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

Model Number G32551

Device Problem Material Separation (1562)

Patient Problem Death (1802)

Event Type  Death  

Event Description

According to the initial reporter: "fenestrated systems are supposed to overlap.The device came disconnected over the past few years, patient died in (b)(6).One device migrated, not confirmed but initial reporter speculates that distal piece is more likely to have migrated.Customer alleging that disconnecting was a contributing factor.Patient presented to er with belly pain at (medical facility), ct scan performed that observed a rupture, patient was transported to (medical facility), facility tried to repair disconnection, and patient died from complications subsequent to the attempt to repair.Subsequent to repair, patient developed compartment syndrome and patient's family declined to have patient go back to surgery." it was reported that the patient expired.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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: 10515247
• MDR Text Key: 206359167
• Report Number: 3005580113-2020-00412
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)181104(10)AC963113
• 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: 09/10/2020

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: 11/04/2018
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC963113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2020
• Date Device Manufactured: 11/04/2015
• 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): Death
• Patient Age: 78 YR