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

Model Number PLC271400

Device Problems Complete Blockage (1094); Unintended Movement (3026)

Patient Problem Thrombus (2101)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, component migration and occlusion of device or native vessel.

Event Description

On (b)(6) 2020, the patient was treated for left common iliac aneurysm.A gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprosthesis were implanted.The procedure was successful, but it was later seen that a separation had occurred between the two devices.In addition, the iliac had completely clotted off.A reintervention is planned.Images were returned for evaluation.The imaging evaluation stated: there appears to be significant tortuosity within aorta, right and left common iliac arteries.Tortuosity significance is greatest in l>r > aorta.No procedural or post implant images were provided.As no additional images were provided, unable to determine how devices were implanted to accommodate the anatomical curvature once the stiff wires were removed.

• 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: 10992715
• MDR Text Key: 220956459
• Report Number: 3013164176-2020-01090
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: 00733132618606
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: PLC271400
• Device Catalogue Number: PLC271400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2020
• Date Device Manufactured: 06/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR