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	G32550
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician decided to modify the graft and make his own fenestration prior to attempted implant.The device top cap did not push off during the procedure.The physician had to convert to open repair for attempted explant.The delivery system had to stay in the patient when going to open repair.
Additional Manufacturer Narrative
The device was not returned for evaluation.Work order (b)(4) was reviewed and appears complete and correct.Additional information was received: could you please clarify ¿this was a case that (b)(6) decided to do modify the graft and make his own fenestration prior to attempted implant.¿ does this mean the physician changed the configuration of the fenestration? the physician removed the graft prior to implantation and made his own fenestration.He then placed the graft back in the sheath and proceeded with the procedure.Can you please clarify the reason for the graft modification? was the graft not manufactured according to the physician¿s expectations? the physician modified the graft because he needed an additional fenestration.The graft was built as he requested.He added an additional fenestration to the proximal graft.Did the patient receive a standard open repair graft, or was the endoluminal graft left in place after removal of the top cap? they attempted to do a standard open repair, but were unable to do so due to the patient bleeding so much.The graft, with top cap still attached was left in the patient.What does the physician believe was the reason for the difficulty with the top cap? he said he has never had that happen and was unsure on why he had the issue top cap.William cook australia medical director reviewed the images provided and stated: "looking at the imaging for this case, it shows a very tortuous aorta and iliac arteries, with multiple directional changes.The fact that the physician modified the graft by pulling it out of the sheath to add an extra fenestration, then replaced it, coupled with the very tortuous nature of the aortoiliac arteries, could well have contributed to the failure of the top cap to separate.We can¿t guarantee that the re-loading of the device into the delivery system complied to the very tight specifications that our loading personnel would have to use.The central cannula may have become twisted, and taking the tortuosity of the access into account, the line of push and pull for the top cap may have been a long way from straight, causing the failure.I note that the open repair was attempted, but couldn¿t be completed due to bleeding, so the top cap and the endograft were left in situ.Presumably, the patient may be being planned for an elective explant and open repair attempt after recovering from the endovascular attempt.It would be very difficult to say that there was a fault with the device or the delivery system, given that the physician modified the device and reloaded it." the device ifu states: "the zenith fenestrated aaa endovascular graft is supplied sterile and pre-loaded in peel-open packages.The device is intended for single use only and the fenestration/scallop location is individually tailored for each patient." based on the information provided there is no evidence to suggest that the product was not manufactured to specification.The device was used off label as the physician unsheathed the graft to make his own fenestration and then reloaded the graft.Work order (b)(4) was reviewed and appears complete and correct.Additional information was received: could you please clarify ¿this was a case that (b)(6) decided to do modify the graft and make his own fenestration prior to attempted implant.¿ does this mean the physician changed the configuration of the fenestration? the physician removed the graft prior to implantation and made his own fenestration.He then placed the graft back in the sheath and proceeded with the procedure.Can you please clarify the reason for the graft modification? was the graft not manufactured according to the physician¿s expectations? the physician modified the graft because he needed an additional fenestration.The graft was built as he requested.He added an additional fenestration to the proximal graft.Did the patient receive a standard open repair graft, or was the endoluminal graft left in place after removal of the top cap? they attempted to do a standard open repair, but were unable to do so due to the patient bleeding so much.The graft, with top cap still attached was left in the patient.What does the physician believe was the reason for the difficulty with the top cap? he said he has never had that happen and was unsure on why he had the issue top cap.William cook australia medical director reviewed the images provided and stated: "looking at the imaging for this case, it shows a very tortuous aorta and iliac arteries, with multiple directional changes.The fact that the physician modified the graft by pulling it out of the sheath to add an extra fenestration, then replaced it, coupled with the very tortuous nature of the aortoiliac arteries, could well have contributed to the failure of the top cap to separate.We can¿t guarantee that the re-loading of the device into the delivery system complied to the very tight specifications that our loading personnel would have to use.The central cannula may have become twisted, and taking the tortuosity of the access into account, the line of push and pull for the top cap may have been a long way from straight, causing the failure.I note that the open repair was attempted, but couldn¿t be completed due to bleeding, so the top cap and the endograft were left in situ.Presumably, the patient may be being planned for an elective explant and open repair attempt after recovering from the endovascular attempt.It would be very difficult to say that there was a fault with the device or the delivery system, given that the physician modified the device and reloaded it." the device ifu states: "the zenith fenestrated aaa endovascular graft is supplied sterile and pre-loaded in peel-open packages.The device is intended for single use only and the fenestration/scallop location is individually tailored for each patient." based on the information provided there is no evidence to suggest that the product was not manufactured to specification.The device was used off label as the physician unsheathed the graft to make his own fenestration and then reloaded the graft.
Event or Problem Description
The physician decided to modify the graft and make his own fenestration prior to attempted implant.The device top cap did not push off during the procedure.The physician had to convert to open repair for attempted explant.The delivery system had to stay in the patient when going to open repair.

• 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: 7524528
• Report Number: 9680654-2018-00018
• Device Sequence Number: 1438599
• Product Code: MIH
• UDI-Device Identifier: 10827002325507
• UDI-Public: (01)10827002325507(17)210309(10)AC1013435
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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 Model Number: G32550
• Device Catalogue Number: ZFEN-P-2-36-137-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/03/2018
• 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
• Patient Age: 76 YR