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	G32554
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
2 months post deployment, physician saw a leak on ct during follow-up (right limb or distal fenestrated piece had an endoleak, but exact location could not be determined.Possibly both.Leak believed to be type 3.Physician scheduled patient for follow-up procedure.Patient brought in for limb extension or cuff procedure, it was unsure what would be needed.Numberous angio runs were done.Right limb was redone from top to bottom.User ballooned device, did another angio run, saw a bit more leaking, did both sides (brought up 2 14x4 atlas balloons, "kissing balloons", to try to inflate it all to expand it, did another angio which improved situation a bit more but it was still leaking a little bit from an undetermined location.User ended up implanting with gore limbs: 20x16x100 (2 ea, one on left side and one on right).User used coda balloons on both sides, inflated, went up and did a final run, and endoleak appeared to be gone.
Event or Problem Description
2 months post deployment, physician saw a leak on ct during follow-up (right limb or distal fenestrated piece had an endoleak, but exact location could not be determined.Possibly both.Leak believed to be type 3.Physician scheduled patient for follow-up procedure.Patient brought in for limb extension or cuff procedure, it was unsure what would be needed.Numberous angio runs were done.Right limb was redone from top to bottom.User ballooned device, did another angio run, saw a bit more leaking, did both sides (brought up 2 14x4 atlas balloons, "kissing balloons", to try to inflate it all to expand it, did another angio which improved situation a bit more but it was still leaking a little bit from an undetermined location.User ended up implanting with gore limbs: 20x16x100 (2 ea, one on left side and one on right).User used coda balloons on both sides, inflated, went up and did a final run, and endoleak appeared to be gone.
Additional Manufacturer Narrative
The device was not returned for evaluation.Work order (b)(4) was reviewed and appears complete and correct.There are a number of processes and checks in place to ensure that there are no holes or tears in the graft prior to shipment.No graft abnormalities were able to be identified from the medical imaging.It was confirmed from review of the medical imaging that the endoleak appeared to be originating from the crutch of the bifurcation of the zfen-d component.The ifu lists endoleak and endoprosthesis issues as potential adverse events, and provides suitable information for safely deploying the distal bifurcated body.Based on the available information, there is no evidence to indicate that a device non-conformance or deficiency contributed to the complaint.The root cause of the endoleak is unknown.

• 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: 10916257
• Report Number: 9680654-2020-00038
• Device Sequence Number: 19166639
• Product Code: MIH
• UDI-Device Identifier: 10827002325545
• UDI-Public: (01)10827002325545(17)230807(10)AC1063736
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 08/07/2023
• Device Model Number: G32554
• Device Catalogue Number: ZFEN-D-12-28-91-C
• Device Lot Number: AC1063736
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/29/2020
• Supplement Report FDA Received Date: 01/31/2021
• 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: Required Intervention