MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	ZFEN-P-2-32-124-R
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The large fenestration for the sma (superior mesenteric artery) vessel ended up posterior instead of anterior on final angio.The graft was properly oriented by physician and dm prior to implant.An additional stent was placed in the sma that extended above fixation stent.
Additional Manufacturer Narrative
Device remains in situ and is not available for evaluation.The work order was reviewed and found to be complete and correct.Review of the order form, submitted by the physician, found no evidence the device was not manufactured to specification.As per qc procedure, the device orientation is checked during manufacturing.Imaging confirmed that the graft was deployed posteriorly instead of anteriorly.Review of the angiographic imaging showed that both the left and right renal arteries were successfully stented with blood flow present, and the sma artery was stented from above, with a catheter/guide wire entering through a strut of the proximal exposed stent of the zfen-p device, into the sma artery, achieving blood flow.The patient's iliac anatomy was reported to be very tortuous.The device was orientated correctly prior to insertion, and no difficulty was experienced in stenting the renal fenestrations.Based on the information provided, there is no evidence that the device was not manufactured to specification, and it appears that the most likely cause of the device rotating was the patient's very tortuous iliac anatomy.Prior to insertion of the device, the physician confirmed the graft orientation by checking the anterior and posterior markers under fluoro, ensuring they formed a cross and rotated correctly, indicating that the device was loaded correctly.Additionally, the two small fenestrations for the renal arteries were the same size and situated almost directly opposite each other, resulting in the anterior and posterior sides of the graft appearing identical under fluoroscopy and making it difficult to determine graft orientation during advancement.The position of the renal fenestrations would also have allowed for them to be successfully stented when the device was deployed posteriorly instead of anteriorly.The ifu sent with the device states to check the orientation of the graft prior to insertion and to avoid twisting the graft.(b)(4).
Event or Problem Description
The large fenestration for the sma (superior mesenteric artery) vessel ended up posterior instead of anterior on final angio.The graft was properly oriented by physician and dm prior to implant.An additional stent was placed in the sma that extended above fixation stent.

• 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: 5506113
• Report Number: 9680654-2016-00003
• Device Sequence Number: 1038037
• Product Code: MIH
• UDI-Device Identifier: 10827002325446
• UDI-Public: (01)10827002325446(17)190112(10)AC966754
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZFEN-P-2-32-124-R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2016
• Supplement Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR