MAUDE Adverse Event Report: W.L. GORE EXCLUDER AAA ENDOPROSTHESIS; SYSTEM ENDOVASCULAR GRAFT

Catalog Number	PLC161000
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
After graft was deployed it was noted that a piece of the delivery device had broken off inside the artery.Broken piece was immediately retrieved by surgeon.

• Brand Name: EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM ENDOVASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE; flagstaff AZ 8003
• MDR Report Key: 5640760
• Report Number: MW5062145
• Device Sequence Number: 2508
• Product Code: MIH
• UDI-Device Identifier: 00733132618668
• UDI-Public: (01)00733132618668
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: PLC161000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2016
• 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: 67 YR
• Patient Weight: 77