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

Model Number PLC271000

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The device was not returned for evaluation.The evaluation was completed using a picture of the device provided.The device evaluation showed the following: the delivery catheter was broken at the trailing olive.The leading end had fractured at the trailing olive.The device was deployed off the delivery catheter.The findings from the evaluation are consistent with the physician¿s observations.The cause for the catheter breakage could not be determined with the available information.The version of the ifu in place at the time of the implant provided the following potentially relevant warnings: the gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly states: do not advance the device outside of the sheath.The sheath will protect the device from catheter breakage or premature deployment while tracking it into position.Do not rotate the contralateral leg delivery catheter during delivery, positioning or deployment.Catheter breakage or premature deployment may occur.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.

Event Description

It was reported that the patient presented with an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.After the gore® excluder® contralateral leg device was successfully implanted, the catheter was removed through the valve of the used gore® dryseal flex sheath (dsf).During the removal through the valve, some resistance was felt and it appeared that the leading end separated from the device catheter.The catheter and the broken leading end were removed from the sheath and the procedure was completed successfully with no reported issues to the patient.

Manufacturer Narrative

Updated g1 g9: please note, the device was manufactured in a different facility than originally reported and the site number should be 3013164176.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9716506
• MDR Text Key: 191176507
• Report Number: 2953161-2020-00003
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618538
• UDI-Public: 00733132618538
• 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
• Report Date: 06/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: PLC271000
• Device Catalogue Number: PLC271000
• Device Lot Number: 21184194
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR