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

Model Number	PLA260300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2020, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm (aaa).The patient presented to the emergency room with chest and abdominal pain.Computed tomography images showed a 7.4cm aaa.It was reported that during the implant procedure the distal tip of the aortic extender endoprosthesis (from the proximal olive down) broke off, it stayed on the guidewire and was snared back into the sheath and out of the body with no harm to patient.An 18fr cook sheath was used on the right side and 12fr gore dry seal on the left side.The trunk-ipsilateral leg endoprosthesis, iliac extender endoprosthesis, and aortic extender endoprosthesis went through the 18fr sheath.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6: code 10-the device was returned to gore for evaluation.Per the evaluation the leading end of the catheter had separated from the catheter body at the trailing olive.The guidewire lumen had pulled out of the trailing olive bond on the catheter.There were imprints of the polyimide guidewire inside the trailing olive indicating that the olive had been bonded to the polyimide guidewire lumen.The findings from the evaluation are consistent with the physician¿s observations.The cause for the catheter separation could not be determined with the currently available information.Addition h6: code 4315-the gore® excluder® aaa endoprosthesis instructions for use (ifu) states: do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter separation and reintervention.

• 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: 10039697
• Report Number: 3013164176-2020-00065
• Device Sequence Number: 2937632
• Product Code: MIH
• UDI-Device Identifier: 00733132618774
• UDI-Public: 00733132618774
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 02/21/2021
• Device Model Number: PLA260300
• Device Catalogue Number: PLA260300
• Device Lot Number: 17817181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 07/07/2020
• 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: PATIENT MEDICATIONS: ASPIRIN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR