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

Model Number	PLC121200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: rlt281218/20189804, udi: (b)(4) and plc271000/18600079, udi: (b)(4).
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses, and treatment of an iliac aneurysm treated with gore® excluder® iliac branch endoprostheses.Reportedly the patient had extreme tortuosity in his abdominal and iliac arteries.It was reported that computed tomography images dated (b)(6) 2019, revealed the gore® excluder® contralateral leg endoprosthesis (plc121200/20695184) migrated proximally (amount of migration is unknown) and pulled up into the aneurysm sac.The gore® excluder® contralateral leg endoprostheses (plc271000/18600079) which was used to bridge the trunk-ipsilateral leg endoprosthesis (rlt281218/20189804) and the aortic excluder iliac branch endoprosthesis (ceb231210a/20775751) had all lost seal in the iliac artery.The physician reintervened on (b)(6) 2019, and relined the two contralateral leg endoprostheses with an additional contralateral leg endoprosthesis, extended the iliac artery with implanting an additional device and implanted an aortic extender endoprosthesis.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Addition b7:- patient comorbidities: hypertension and current substance abuse.Addition h6: code 213-a review of the manufacturing records for the devices verified that these lots met all pre-release specifications.Addition h6: code 22-according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events which may occur and require intervention include component migration.
Additional Manufacturer Narrative
Correction upon review, it has been determined there is no allegation of deficiency on the (b)(6).Udi-(b)(4).Device.

• 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: 9378573
• Report Number: 3013164176-2019-00160
• Device Sequence Number: 14245714
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/09/2020

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: 06/09/2022
• Device Model Number: PLC121200
• Device Catalogue Number: PLC121200
• Device Lot Number: 20695184
• 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: 11/26/2019
• Supplement Report FDA Received Date: 02/04/2020; 04/09/2020
• 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; Required Intervention