PulseCath iVAC 2L Post-Market Surveillance Form

Operator *

First

Last

Layout

Hospital *

Country *

Date *

(dd/mm/yyyy)

Serial number: *

NYHA (Heart failure classification)

Value (1 - 4)

Layout

Age *

Weight (Kg) *

Gender *

Height (cm) *

Indication *

*Other, please specify:

Layout

SYNTAX 1 *

EF (%) *

STS mort. *

Antecedents

Mark if present *

Lesion

	REGURG	STENOSIS
Valve	REGURGValve REGURG	STENOSISValve STENOSIS
Aortic	REGURGAortic REGURG	STENOSISAortic STENOSIS
Mitral	REGURGMitral REGURG	STENOSISMitral STENOSIS
Tricuspid	REGURGTricuspid REGURG	STENOSISTricuspid STENOSIS
Pulmonic	REGURGPulmonic REGURG	STENOSISPulmonic STENOSIS

Severity

	MILD	MOD	SEVERE
Valve	MILDValve MILD	MODValve MOD	SEVEREValve SEVERE
Aortic	MILDAortic MILD	MODAortic MOD	SEVEREAortic SEVERE
Mitral	MILDMitral MILD	MODMitral MOD	SEVEREMitral SEVERE
Tricuspid	MILDTricuspid MILD	MODTricuspid MOD	SEVERETricuspid SEVERE
Pulmonic	MILDPulmonic MILD	MODPulmonic MOD	SEVEREPulmonic SEVERE

Treatment - indicate lesion severity and mark "STENT' if treated

Layout

LM (Left Main) *

LAD (Left Ant. Desc.) *

1DG (1st Diagonal) *

2DG (2nd Diagonal) *

SB (Septal Branch) *

LCx (Circumflex) *

1OM (1st Obtuse Marginal) *

2OM (2nd Obtuse Marginal) *

LPD (Left Posterior Desc.) *

RI (Intermediate Branch) *

RCA (Right Coronary) *

RPD (Post. Desc.) *

PL (Posterolateral) *

Bypass Graft *

Other, fill in on line below*: *

*Other, please specify:

Layout

N. of lesions treated *

N. of stents deployed *

Highest ACT *

Click on what applies *

Layout

iVAC Start *

Date

Time

(dd/mm/yyyy) (xx:xx)

Max. iVAC2L flow (L/min) *

Sheath (name/size/serial n) *

iVAC end *

Date

Time

(dd/mm/yyyy) (xx:xx)

Access site *

Layout

Assist Mode *

1:1 synch
1:3 synch
Internal

Total IV fluids (mL) *

Hospital Admission *

Date

Time

(dd/mm/yyyy) (xx:xx)

Vasc. Closure *

MANTA
PROGLIDE
SURGICAL

Total contrast (mL) *

Hospital Discharge *

Date

Time

(dd/mm/yyyy) (xx:xx)

Intraprocedural Events & Clinical Outcomes

Mark if present *

*Other, please specify:

No Major adverse Events at 30 days *

No major events
Major events: check below

Major Adverse events (mark if occurred)

	Pre Discharge	<30 Days	<90 Days	<1 Year
Cerebrovasc. event	Pre DischargeCerebrovasc. event Pre Discharge	<30 DaysCerebrovasc. event <30 Days	<90 DaysCerebrovasc. event <90 Days	<1 YearCerebrovasc. event <1 Year
Acute MI	Pre DischargeAcute MI Pre Discharge	<30 DaysAcute MI <30 Days	<90 DaysAcute MI <90 Days	<1 YearAcute MI <1 Year
Acute Kidney Injury	Pre DischargeAcute Kidney Injury Pre Discharge	<30 DaysAcute Kidney Injury <30 Days	<90 DaysAcute Kidney Injury <90 Days	<1 YearAcute Kidney Injury <1 Year
Cardiac/vasc. operation	Pre DischargeCardiac/vasc. operation Pre Discharge	<30 DaysCardiac/vasc. operation <30 Days	<90 DaysCardiac/vasc. operation <90 Days	<1 YearCardiac/vasc. operation <1 Year
Major bleeding	Pre DischargeMajor bleeding Pre Discharge	<30 DaysMajor bleeding <30 Days	<90 DaysMajor bleeding <90 Days	<1 YearMajor bleeding <1 Year
Death	Pre DischargeDeath Pre Discharge	<30 DaysDeath <30 Days	<90 DaysDeath <90 Days	<1 YearDeath <1 Year
Emergent Revasc.	Pre DischargeEmergent Revasc. Pre Discharge	<30 DaysEmergent Revasc. <30 Days	<90 DaysEmergent Revasc. <90 Days	<1 YearEmergent Revasc. <1 Year

Pre support

Layout

Heart rate

Pulmonary pressure

Blood pressure

Cardiac output

Sp02 (%)

mPCWP

Sp02 (%) (iVAC2L LEG/ CONTRALATERAL LEG)

During support (minimal 10 min)

Layout

Heart rate

Pulmonary pressure

Blood pressure

Cardiac output

Sp02 (%)

mPCWP

Sp02 (%) (iVAC2L LEG/ CONTRALATERAL LEG)

Post-removal

Layout

Heart rate

Pulmonary pressure

Blood pressure

Cardiac output

Sp02 (%)

mPCWP

Sp02 (%) (iVAC2L LEG/ CONTRALATERAL LEG)

We would greatly appreciate if you could inform PulseCath of any adverse events detected post PCI and post discharge. Thank you for contributing to our PMS registry!

RF-64-03 February 2023

Antecedents

Treatment - indicate lesion severity and mark "STENT' if treated

Intraprocedural Events & Clinical Outcomes

Pre support

During support (minimal 10 min)

Post-removal

iVAC 2L Procedure Steps

iVAC 2L Setup

iVAC 2L Trouble Shooting

iVAC 2L Clinical Effect

PulseCath iVAC 2L Post-Market Surveillance Form