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

Model Number PLC121000

Device Problems Material Separation (1562); Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

This event also includes device (b)(4).

Event Description

On (b)(6) 2020, the patient was treated for an abdominal aortic aneurysm.The physician successfully implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system.He then implanted a gore® excluder® aaa endoprosthesis.After it was deployed, the physician went to remove the delivery system, and in doing so, the balloon valve on the gore® dryseal sheath with hydrophilic coating was ruptured.The delivery system, and sheath were removed, and a second gore® dryseal sheath with hydrophilic coating was used to complete the procedure.The patient tolerated the procedure.After the procedure, the sheath and delivery catheter were examined.The distal nose cone on the delivery system was found to have broken, with about 1 cm of the distal end separated from the rest of the nose cone.The sheath and delivery catheter will be returned for investigation.The physician is requesting a response.The physician reported that the neck of the aorta was heavily calcified.

Manufacturer Narrative

The device evaluation showed the following: the tip of the leading olive was missing from the catheter leading olive.The guidewire lumen of the catheter was exposed due to the leading olive tip separation.The tip of the leading olive was not returned for evaluation.The fsa was asked during the evaluation if the tip of the leading olive was found.The fsa reported that the tip of the olive was found in the device packaging.The packaging materials were not returned for evaluation.The findings from the evaluation are consistent with the physician¿s observations.The cause for the tip of the separating from the catheter could not be determined with the currently available information.

• 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
• MDR Report Key: 10730375
• MDR Text Key: 214599730
• Report Number: 3013164176-2020-01063
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618613
• UDI-Public: 00733132618613
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: PLC121000
• Device Catalogue Number: PLC121000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 09/28/2020
• Supplement Dates FDA Received: 02/02/2021; 07/07/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104