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	G32542
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
The graft in-folded on itself.It did not get to its full diameter.It was over-sized so it crinkled and created a type one endoleak.It invaginated on itself.No reintervention has been performed yet.The doctor will bring the patient back in a few months to see if the problem has resolved on its own.
Event or Problem Description
The graft in-folded on itself.It did not get to its full diameter.It was over-sized so it crinkled and created a type one endoleak.It invaginated on itself.No reintervention has been performed yet.The doctor will bring the patient back in a few months to see if the problem has resolved on its own.
Additional Manufacturer Narrative
The device was not returned for evaluation.Additional information was received: "heparin was administered prior to beginning the procedure.The procedure involved a narrowed neck anatomy, -60 cc of saline in 32 coda balloon was the inflation volume of the balloon used at the proximal seal zone using a -60 cc syringe.No high blood pressure of graft obstruction was detected during the procedure." it was confirmed to be a type 1a (proximal), with zfen accessories and icast stents placed in the renal arteries.The leak was detected on angiogram and confirmed via ct.Three requests have been made for medical imaging however no imaging has been received.Work order (b)(4) was reviewed and appears complete and correct.There are a number of processes and checks in place which would ensure the graft is manufactured to the correct dimensions.The device ifu states: "key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (> 45 degrees for infrarenal neck to axis of aaa or > 45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<4 mm); greater than 10% increase in diameter over 15 mm of proximal aortic neck length; and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.Irregular calcification and/or plaque may compromise the fixation and sealing of the implantation sites.Necks exhibiting these key anatomic elements may be more conducive to graft migration"."potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak and 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".Based on the information provided, the root cause of the difficulty reported by the customer is unknown.It is possible that one of more of the following factors may have contributed to this complaint: inaccurate implant placement.Incomplete expansion of implant.Mismatch of implant dimensions to patient anatomy.Proximal stent detachment.Specification reducing ties tied incorrectly.Patient related factors.Procedural 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: 8726387
• Report Number: 9680654-2019-00019
• Device Sequence Number: 13918284
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)220416(10)AC1035882
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/16/2019

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: 04/16/2022
• Device Model Number: G32542
• Device Catalogue Number: ZFEN-P-2-28-124-R
• Device Lot Number: AC1035882
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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: ICAST STENTS; ICAST STENTS
• Outcome Attributed to Adverse Event: Other