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-2-36-137-R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The physician opened the package and noticed that the hydrophilic coating on the sheath was flaking off.He wiped down the coating with saline and tried remove all the flakiness from the device.
Additional Manufacturer Narrative
The product was not returned therefore no physical evaluation of the device could be completed however a photo of the complaint device was supplied confirming the complaint.The work order record for ac980695 was reviewed and appeared complete and correct.One-hundred percent (100%) of sheath assemblies are qc inspected at incoming qc for any surface non-conformities, including flaking and peeling, based on the information present, a definitive root cause for the complaint could not be determined.Appropriate personnel will continue to monitor for similar events.The product was not returned therefore no physical evaluation of the device could be completed however a photo of the complaint device was supplied confirming the complaint.The work order record for ac980695 was reviewed and appeared complete and correct.One-hundred percent (100%) of sheath assemblies are qc inspected at incoming qc for any surface non-conformities, including flaking and peeling, based on the information present, a definitive root cause for the complaint could not be determined.Appropriate personnel will continue to monitor for similar events.
Event or Problem Description
The physician opened the package and noticed that the hydrophilic coating on the sheath was flaking off.He wiped down the coating with saline and tried remove all the flakiness from the device.

• 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: 6084552
• Report Number: 9680654-2016-00015
• Device Sequence Number: 1136216
• Product Code: MIH
• UDI-Device Identifier: 10827002325507
• UDI-Public: (01)10827002325507(17)190826(10)AC980695
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/07/2016

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ZFEN-P-2-36-137-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1