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

Model Number	PLC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2021, the patient underwent treatment for an abdominal aortic aneurysm with the implant of a gore® excluder® aaa endoprosthesis featuring c3® delivery system.Post-op, the patient developed back pain.A ct and cta were obtained, which were suspicious for extravasation.Review of earlier films showed some extravasation at the distal end of the left limb, (plc201400).It was felt that this likely occurred during ballooning with a mob37 balloon.The patient was brought back on the same day for successful extension of the left limb using another plc201400.Final angiogram showed a well placed device with no evidence of endoleak or extravasation.The final angiogram during the index procedure was suboptimal due to the physician trying to limit contrast and they did not recognize the small extravasation at that time.The ct scan showed what appeared to be blood collected in the pelvis but no active bleeding was seen at the time of the scan.The index procedure films were reviewed again and the small extravasation was found at the distal end of the left limb.It was felt the bleeding probably started after ballooning the limb and then stopped by the time the ct was obtained.The patient was pain free today and doing well.The balloon was a mob37, lot 22597123.

• 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: 11634529
• Report Number: 3013164176-2021-01151
• Device Sequence Number: 3683540
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: 10/26/2023
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 93