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

Model Number	PLA360400
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical history includes but is not limited to: aaa, carotid endarterectomy, afib, cad, cva, hyperlipidemia, tia.Concomitant medical products: medications include but are not limited to: crestor, warfarin, levos sporaxine, vitamin e, potassium acetate.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, the aortic extender endoprosthesis (aortic extender) provides an extension of approximately 1.6 cm or 2.2 cm of the leading (proximal) end of the trunkipsilateral leg endoprosthesis (trunk).
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.Two gore® aortic extender components were placed proximally and coverage was extended distally on either side with two contralateral leg components.A pla36060 device was reported to be the most proximal device; no trunk ipsilateral leg component was implanted.The patient tolerated the procedure.On (b)(6) 2020, the patient underwent reintervention for a possible type i or type iii endoleak.The type of endoleak was unable to be determined intraprocedure.An additional aortic extender component was implanted proximally, but did not resolve the endoleak.Another aortic extender component was then placed just above the aortic bifurcation, however the endoleak still persisted.The physician then chose to reline the entire system originally implanted.A trunk ipsilateral leg component was placed proximally, and extended with another contralateral leg component.This successfully resolved the endoleak.There was no reported migration or aneurysm enlargement.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Additional Manufacturer Narrative
D11: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pla320400/20086581.Medications include but are not limited to: crestor, warfarin, levos sporaxine, vitamin e, potassium acetate.Medical history includes but is not limited to: aaa, carotid endarterectomy, afib, cad, cva, hyperlipidemia, tia.

• Brand Name: GORE EXCLUDER CONFORMABLE 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: 10203977
• Report Number: 3013164176-2020-01000
• Device Sequence Number: 14027796
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2020

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: 01/23/2022
• Device Model Number: PLA360400
• Device Catalogue Number: PLA360400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 06/24/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/17/2020; 07/31/2020
• 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: SEE H10/11.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 88 YR
• Patient Weight: 65