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

Model Number	PLC181400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note: the device is being returned to gore for analysis but has not yet been received.The results of any analysis will be provided in a supplemental medwatch.
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment and was implanted with gore® excluder® aaa endoprostheses.Post deployment of a contralateral leg component, during removal of the device delivery catheter the leading olive became detached from the catheter and remained in the patient.The detached portion was snared and removed from the patient without issue.The patient tolerated the procedure.
Additional Manufacturer Narrative
The device was not returned for evaluation.The evaluation was completed based only on the event descriptions as reported to gore.Without a physical sample to evaluate, the physician¿s observation that the leading olive became detached from the catheter could not be confirmed with the available information.The likely cause for the detached leading olive could not be determined with the currently available information.The evaluation of the reported event appears consistent with a leading olive separation; however, it is not possible to determine if there was a tensile failure of the bond, no bond or a break in the catheter polyimide because the device was not available for evaluation.

• 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: 11290031
• Report Number: 3013164176-2021-01114
• Device Sequence Number: 19880820
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: 00733132618699
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2023
• Device Model Number: PLC181400
• Device Catalogue Number: PLC181400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR