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

Model Number	PLA320400
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a gore® excluder® aaa aortic extender endoprosthesis (pla) was advance over a 0.35¿ lunderquist guidewire outside of the patient and got stuck on the guidewire during an implant procedure.Further advancement into the patient was not possible.It was stated that the guidewire was wiped with a wet gauze and the device was flushed according to the instructions for use previously.During a forceful attempt to remove the device of the guidewire the proximal olive of the pla became detached.The issue had no reported effects on the patient and the implant procedure was completed as planned.
Event or Problem Description
It was reported that a gore® excluder® aaa aortic extender endoprosthesis (pla) was advance over a 0.35¿ lunderquist guidewire outside of the patient and got stuck on the guidewire during an implant procedure.Further advancement into the patient was not possible.It was stated that the guidewire was wiped with a wet gauze and the device was flushed according to the instructions for use before usage.During a forceful attempt to remove the device of the guidewire the device pulled of the leading end of the catheter.Since the issue occurred outside of the patient, no effects to the patient occurred.The implant procedure was completed with a new pla with favorable results.
Additional Manufacturer Narrative
The device was returned to w.L.Gore & associates for evaluation.The device evaluation showed the following: the leading end of the catheter had separated from the catheter body at the trailing olive.The leading end of the catheter was not returned for evaluation.The guidewire lumen had pulled out of the trailing olive bond on the catheter.There were imprints of the polyimide guidewire inside the trailing olive indicating that the olive had been bonded to the polyimide guidewire lumen.The returned portion of the catheter was loaded over a guidewire.The catheter was able to be loaded over a guidewire.The findings from the evaluation are consistent with the physician¿s observations for catheter separation.The physician¿s observation that the catheter was difficult to load over a guidewire could not be confirmed with the currently available information.The gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly states: do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.The cause for difficulty advancing the catheter over a guidewire could not be determined with the currently available information.The cause for the catheter separation could not be determined with the currently available information.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9558153
• Report Number: 3013164176-2020-00003
• Device Sequence Number: 2461072
• Product Code: MIH
• UDI-Device Identifier: 00733132618804
• UDI-Public: 00733132618804
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2021
• Device Model Number: PLA320400
• Device Catalogue Number: PLA320400
• Device Lot Number: 18675849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1