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
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Event or Problem Description
According to the initial reporter: "fenestrated systems are supposed to overlap.The device came disconnected over the past few years, patient died in april.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.
Event or Problem Description
According to the initial reporter: "fenestrated systems are supposed to overlap.The device came disconnected over the past few years, patient died in april.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.
Additional Manufacturer Narrative
The device was not returned for evaluation.Three request were made to obtain medical imaging but no imaging were provided.The work order ac963112 was reviewed and appears correct and complete.The graft appears to be manufactured as per the approved by physician order.The device ifu states that the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established, and all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak, component migration.Based on the information provided, the root cause of the difficulty reported by the healthcare facility is unknown.It is possible that the separation was due to: insufficient fixation (friction) between the proximal and distal components.Inadequate retention forces.Distal device separation.Patient-related factors.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: 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: 10449963
• Report Number: 9680654-2020-00027
• Device Sequence Number: 3524680
• Product Code: MIH
• UDI-Device Identifier: 10827002325484
• UDI-Public: (01)10827002325484(17)181104(10)AC963112
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2018
• Device Model Number: G32548
• Device Catalogue Number: ZFEN-P-2-36-122-R
• Device Lot Number: AC963112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR