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	G32501
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Original implant was on (b)(6) 2016.Successful outcome with no leak during final imaging.Patient was seen in (b)(6) 2018 where computerized tomography (ct) was performed and no leak was discovered.On (b)(6) 2019, patient came to hospital complaining of abdominal pain.Ct showed blood in the retroperitoneum coming from type 3 endoleak.The leak was located around the distal bifurcated stent graft.The leak was repaired by relining with gore stent graft.Final imaging showed no leak.Some iliac calcification and tortuosity was noted.
Additional Manufacturer Narrative
Images were provided and reviewed by medical director at william cook australia: "i cannot really see any endoleak, cannot see the retroperitoneal bleeding, and cannot draw any conclusions as to the effectiveness of the re-lining by the gore graft.".
Event or Problem Description
Original implant was on (b)(6) 2016.Successful outcome with no leak during final imaging.Patient was seen in 6/2018 where computerized tomography (ct) was performed and no leak was discovered.On (b)(6) 2019, patient came to hospital complaining of abdominal pain.Ct showed blood in the retroperitoneum coming from type 3 endoleak.The leak was located around the distal bifurcated stent graft.The leak was repaired by relining with gore stent graft.Final imaging showed no leak.Some iliac calcification and tortuosity was noted.
Event or Problem Description
Original implant was on (b)(6) 2016.Successful outcome with no leak during final imaging.Patient was seen in 6/2018 where computerized tomography (ct) was performed and no leak was discovered.On (b)(6) 2019, patient came to hospital complaining of abdominal pain.Ct showed blood in the retroperitoneum coming from type 3 endoleak.The leak was located around the distal bifurcated stent graft.The leak was repaired by relining with gore stent graft.Final imaging showed no leak.Some iliac calcification and tortuosity was noted.
Additional Manufacturer Narrative
The device was not returned for evaluation and remains in-situ.Images were provided and reviewed by medical director at william cook australia: "i cannot really see any endoleak, cannot see the retroperitoneal bleeding, and cannot draw any conclusions as to the effectiveness of the re-lining by the gore graft.".Work order (b)(4) was reviewed and appears complete and correct.The device ifu states: "endoleak" is listed as a potential adverse event."patients with specific clinical findings (e.G.,endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up" "the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up" based on the information provided the exact failure mode cannot be determined as it is unclear if the type iii endoleak is caused as a result of stitch breakage, tearing of material, material degradation, stent detachment, etc.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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: 8661390
• Report Number: 9680654-2019-00017
• Device Sequence Number: 2086961
• Product Code: MIH
• UDI-Device Identifier: 10827002325019
• UDI-Public: (01)10827002325019(17)191125(10)AC985794
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2019

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: 11/25/2019
• Device Model Number: G32501
• Device Catalogue Number: ZFEN-D-12-28-121-C
• Device Lot Number: AC985794
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 05/16/2019
• Initial Report FDA Received Date: 06/02/2019
• Supplement Report FDA Received Date: 06/30/2019; 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATRIUM ICASTS, BOSTON SCIENTIFIC EXPRESS; ATRIUM ICASTS, BOSTON SCIENTIFIC EXPRESS; ATRIUM ICASTS, BOSTON SCIENTIFIC EXPRESS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR