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

Catalog Number PLC161000

Device Problem Material Fragmentation (1261)

Patient Problem Not Applicable (3189)

Event Date 12/29/2018

Event Type  malfunction  

Manufacturer Narrative

Gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly states: 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

The following information was reported to gore: on (b)(6) 2018 a patient was treated for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis.The device was accessed from the femoral artery and the left iliac artery was found excessively tortuous during advancing.It was reported that the contralateral leg component was successfully deployed.It was noted the leading olive was separated from the delivery system and left inside the patient's artery when the device was retracted from the patient.Then the physician used the snare to retrieve the leading olive under angiography successfully.The patient did not experience any adverse consequences.

Manufacturer Narrative

Updated h7.Updated conclusion code.

• 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: 9283378
• MDR Text Key: 203686925
• Report Number: 3013164176-2019-00146
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2019

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 Catalogue Number: PLC161000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1