MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G55233

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that saline leaked through the valve of a zenith flex with spiral-z technology aaa endovascular graft iliac leg device during flushing.During preparation, while flushing through the stopcock, the valve was reported to have leaked "as if it were broken".No patient contact was made.Another device was used to successfully complete the intended procedure.

Event Description

Upon device receipt, an inspection was completed confirming that the leak for the complaint device did not come from the valve but rather from the pin vise.The failure mode "pin vise leaks" for this device does not meet the qualifications for a reportable product malfunction.Therefore, no further reports concerning this event will be submitted.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9627310
• MDR Text Key: 177373647
• Report Number: 1820334-2020-00203
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002552330
• UDI-Public: (01)10827002552330(17)210327(10)8675304
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/27/2021
• Device Model Number: G55233
• Device Catalogue Number: ZSLE-13-90-ZT
• Device Lot Number: 8675304
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1