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

Model Number PLC201400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Pain (1994)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11634529
• MDR Text Key: 244447476
• Report Number: 3013164176-2021-01151
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/08/2021
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 93