FDA Adverse Event Injury Summary report: N

ZENITH FENESTRATED GRAFT

MDR report key: 15911518 · Received December 2, 2022

Report

Report Number
3005580113-2022-00129
Event Type
Injury
Date Received
December 2, 2022
Report Date
December 2, 2022
Manufacturer
WILLIAM A. COOK AUSTRALIA, PTY LTD
Product Code
MIH
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENTS WERE DIVIDED INTO LARGE DIAMETER (LD) GROUP AND NORMAL DIAMETER (ND) GROUP. PATIENTS IN THE LARGE DIAMETER (LD) GROUP WERE TREATED WITH LARGER DIAMETER ZFEN DEVICES (EITHER 34 MM OR 36 MM). PATIENTS IN THE NORMAL DIAMETER (ND) GROUP WERE TREATED WITH LESS THAN/EQUAL TO 32 MM ZFEN DEVICES. PATIENTS WERE FOLLOWED POSTOPERATIVELY BY CTA [COMPUTER TOMOGRAPHY ANGIOGRAM] AND/OR DUPLEX ULTRASOUND. MEAN FOLLOW-UP TIME WAS 22 MONTHS. ONE HUNDRED (100) PATIENTS WERE TREATED FROM 2012-2017 WITH THE ZFEN DEVICE. IN ADDITION TO LARGER NECKS, PATIENTS IN THE LARGE DIAMETER (LD) GROUP HAD SHORTER, AND LESS ANGULATED INFRARENAL NECKS. PERCENT OVERSIZING WAS SIGNIFICANTLY LESS IN THE LARGE DIAMETER (LD) GROUP. LARGE DIAMETER (LD) GROUP 19.05% +/- 18.25%. NORMAL DIAMETER (ND) GROUP 24.27% +/- 12.01%. AAA DIAMETER FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 58.5 MM +/- 9.6 MM. AAA DIAMETER FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 61.0 MM +/- 17.4 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 23.4 MM +/- 3.2 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 30.1 MM +/- 5.3 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 4.7 MM +/- 3.44 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 2.6 MM +/- 2.9 MM. INFRARENAL ANGULATION FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 31.7 DEGREES +/- 19.4 DEGREES. INFRARENAL ANGULATION FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 21.5 DEGREES +/- 12.1 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 24.8 DEGREES +/- 18.9 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 16.5 DEGREES +/-15.8 DEGREES. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 18. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 8. 1 PATIENT (NORMAL DIAMETER (ND) GROUP) HAD SMA STENT OCCLUSION THAT REQUIRED REINTERVENTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2430390 ZENITH FENESTRATED GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 Unknown Required Intervention