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

Model Number	PLA320400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications include but are not limited to: doxycycline, amoxicillin, azathioprine, meteor in, clopidogrel, rivaroxaban, pantoprazole, lisinopril, hydrochlorothiazide, glipizide, atorvastatin, aspirin, insulin.Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pla320400/16451607, udi:(b)(4).Pla360400/20741938 udi: (b)(4)., please note that this event was reported in medwatch 2017233-2020-00423.Details of the event required a separate medwatch submission for the aortic extender components.As such this medwatch is being submitted.Results pending completion of manufacturing evaluation.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to aneurysm enlargement.
Event or Problem Description
On (b)(6) 2010, this patient underwent treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.It was reported that the proximal placement of the trunk ipsilateral leg component was landed approximately 2 cm below the lowest (accessory) renal artery.On (b)(6) 2018, the patient underwent reintervention for a proximal type i endoleak and aneurysm enlargement (amount unknown).Two gore® excluder® aortic extender components were placed proximally to extend coverage of the trunk and resolved the endoleak.The patient tolerated the procedure.On (b)(6) 2020, the patient underwent reintervention due to expansion of the aneurysm sac and a gore® aortic extender component was implanted to reline the proximal end.The cause of the enlargement was not determined; a type ii endoleak was suspected however no visible endoleak was determined by contrast imaging at the time.The patient tolerated the procedure.On (b)(6) 2020, the patient underwent reintervention due to one of the aortic extender component appearing to have a distal bird beak and the patient was experiencing belly pain.An additional aortic extender component was placed proximally and two contralateral leg component were relined within the main body.The patient tolerated the procedure.The physician reported that follow up computed tomography (ct) scan looked good, with stable sac size and no belly pain.
Additional Manufacturer Narrative
H6: code 213: a review of the manufacturing records verified the device met all pre-release specifications.
Additional Manufacturer Narrative
G5: additional/corrected information.H6: code 213: a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.Images were provided to gore for evaluation and showed the following: the com log states that the patient had a re-intervention on (b)(6) 2020 where an excluder aortic extender was placed just distal to the lowest renal artery.However, the imaging provided for review is dated (b)(6) 2020, and there is an aortic extender in situ just distal to the lowest renal artery.Centerline reconstruction illustrates that the trunk ipsilateral component was placed approximately 15mm distal to the left renal artery and it also illustrates an aortic cuff implanted just distal to the left renal artery.Axial images from the non-con, arterial, and venous phases illustrate a density of unknown origin.Endoleak indeterminate.

• 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: 10169401
• Report Number: 2953161-2020-00017
• Device Sequence Number: 11298511
• Product Code: MIH
• UDI-Device Identifier: 00733132618804
• UDI-Public: 00733132618804
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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: 06/27/2020
• Device Model Number: PLA320400
• Device Catalogue Number: PLA320400
• Device Lot Number: 16451624
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/13/2020; 09/16/2020
• 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; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 60