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

Model Number	PXL161407
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the devices verified the lot met all pre-release specifications.Also were implanted: pxt261414 /8398133 udi# (b)(4).Pxc201200/ 8607067 udi# (b)(4).(b)(4).According to the gore® excluder® aaa endoprostheses instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and aneurysm enlargement.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.For pxl161407 the intended iliac inner diameter is 12-13.5mm.As the date of the follow up examination where the distal type i endoleak was discovered is unknown, the reintervention date (b)(6) 2020 will be used as an event date.
Event or Problem Description
On (b)(6) 2011, this patient underwent endovascular treatment using gore® excluder® aaa endoprostheses for abdominal aortic aneurysm.On an unknown date, a follow-up examination revealed a distal type i endoleak in the left limb.On (b)(6) 2020, the patient underwent reintervention.The left internal iliac artery was coil embolized, and an additional stent graft was deployed to extend the device to the left external iliac artery.The endoleak was resolved.Reportedly, no endoleak was observed in the proximal neck and the right limb, however, an aortic extender endoprosthesis and a contralateral leg endoprosthesis were deployed to prevent a future type i endoleak.The patient tolerated the procedure.It was suggested as a possible cause of distal type i endoleak was that the left limb device would be undersized.In addition, it was reported that the blood vessel diameter around the left limb was enlarged from approx.13 mm to 16 mm.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10463559
• Report Number: 2953161-2020-01015
• Device Sequence Number: 19555549
• Product Code: MIH
• UDI-Device Identifier: 00733132610082
• UDI-Public: 00733132610082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 07/31/2013
• Device Model Number: PXL161407
• Device Catalogue Number: PXL161407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/27/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 78 YR