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	G32538
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A type iii endoleak was noted between the proximal and distal components.The devices were re-ballooned at the overlap and the fabric was torn due to ballooning.An additional graft (esbe-32-39-zt) was placed to repair the tear.The leak persisted, but appeared to partially resolve.The patient was discharged, and will return in 30 days for a scan.
Additional Manufacturer Narrative
The device was not returned for evaluation.Medical imaging was provided for this case and reviewed by william cook australia medical affairs director, who made the following assessment: "when they say that the fabric was torn by the balloon, we don¿t have any imaging to confirm that is what happened ¿ only the site¿s report that it is what they think happened.Also, the sentence about the leak persisting but appeared to partially resolve, is somewhat vague, and i am assuming that the reversal or wearing off of the heparin caused the leak to slow down.This would imply that the leak was small, as a significant tear of the graft fabric would not be sealed by heparin reversal.Having now received the 30-day post procedure ct scans, i can add that it all looks like a good result.Of note, i can see the double layered overlapping grafts at the main body overlap ¿ and the type 3 endoleak they reported no longer appears to be present.I can also see the double layered iliac limb stent grafts where they re-lined the first ones after they had shortened during deployment.The right internal iliac artery has amplatzer plugs in it, but there seems to be good backflow via cross-pelvic collaterals.The main iliac limbs are in crossed configuration, an incidental noting, but of no clinical significance.To summarize, the problems reported in the original complaint appear to have resolved with a good end result.I can¿t shed any light or confirm any possible cause of the type 3 endoleak originally reported, as we don¿t have imaging from the index procedure." work order: (b)(4) was reviewed and appears complete and correct.The ifu provided with the device states: "potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak; endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion".From the information provided in the complaint it is difficult to determine a definitive root cause to explain the difficulty experienced by the customer and patient.It is most likely that one or more of the following factors contributed to the complaint: tearing of graft material due to over-ballooning of overlap area wear/abrasion/biodegradation at interface site between components procedural factors.
Event or Problem Description
A type iii endoleak was noted between the proximal and distal components.The devices were re-ballooned at the overlap and the fabric was torn due to ballooning.An additional graft (esbe-32-39-zt) was placed to repair the tear.The leak persisted, but appeared to partially resolve.The patient was discharged, and will return in 30 days for a scan.

• 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: 9270651
• Report Number: 9680654-2019-00045
• Device Sequence Number: 145990
• Product Code: MIH
• UDI-Device Identifier: 10827002325385
• UDI-Public: (01)10827002325385(17)220314(10)AC1033772
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 03/14/2022
• Device Model Number: G32538
• Device Catalogue Number: ZFEN-P-2-30-109-R
• Device Lot Number: AC1033772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/03/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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: Required Intervention
• Patient Age: 72 YR