ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG G48451 TFLE-12-90-ZT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-30 for ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG G48451 TFLE-12-90-ZT manufactured by Cook Inc.

MAUDE Entry Details

• Report Number: 1820334-2020-00711
• MDR Report Key: 9898697
• Report Source: DISTRIBUTOR,FOREIGN,HEALTH PR
• Date Received: 2020-03-30
• Date of Report: 2020-03-30
• Date of Event: 2019-06-11
• Date Mfgr Received: 2020-03-16
• Device Manufacturer Date: 2019-04-22
• Date Added to Maude: 2020-03-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. JENNIFER CANADA
• Manufacturer Street: 750 DANIELS WAY
• Manufacturer City: BLOOMINGTON IN 47404
• Manufacturer Country: US
• Manufacturer Postal: 47404
• Manufacturer Phone: 8123392235
• Manufacturer G1: COOK INC
• Manufacturer Street: 750 DANIELS WAY
• Manufacturer City: BLOOMINGTON IN 47404
• Manufacturer Country: US
• Manufacturer Postal Code: 47404
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG
• Generic Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Product Code: MIH
• Date Received: 2020-03-30
• Returned To Mfg: 2019-06-18
• Model Number: G48451
• Catalog Number: TFLE-12-90-ZT
• Lot Number: 9647374
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK INC
• Manufacturer Address: 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-30