MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PLC161200
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Refer to field for the results of the imaging evaluation.
Event or Problem Description
The following was reported to gore: on (b)(6) 2016, the patient presented with a ruptured abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses in an emergency procedure.On (b)(6) 2018, a type iii endoleak on the patients left was discovered due to insufficient overlap between two contralateral leg endoprostheses.It was also stated that the aneurysm diameter increased from 82-83mm to 84mm.On (b)(6) 2018, a reintervention was successfully performed by relining the separated components with an additional contralateral leg endoprosthesis.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7760893
• Report Number: 2953161-2018-00070
• Device Sequence Number: 19271821
• Product Code: MIH
• UDI-Device Identifier: 00733132618705
• UDI-Public: 00733132618705
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: 10/31/2018
• Device Catalogue Number: PLC161200
• Device Lot Number: 14471833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2018
• 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: PXC141000/(B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR