MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G32548

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 04/21/2020

Event Type  Injury  

Event Description

According to the initial reporter:: "zfen was involved in procedure, but physician believes icast was allegedly the problem device (limited blood flow into the patient's right renal)." it was further reported: an icast was used on rt renal.5x22x120.Other devices used during the procedure: cook distal body 12-28-76 , zsle rt iliac, zsle.Left iliac and icast in left renal 6x22x120.This was a fenestrated case.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 10009535
• MDR Text Key: 191426485
• Report Number: 3005580113-2020-00357
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325484
• UDI-Public: (01)10827002325484(17)220930(10)AC1045694
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2020,04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: G32548
• Device Catalogue Number: ZFEN-P-2-36-122-R
• Device Lot Number: AC1045694
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2020
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR