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

Model Number	PLC231400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the patient presented with an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.It was stated that after a gore® excluder® aaa contralateral leg endoprosthesis (plc) was advanced outside of the sheath, it was tried to retract the plc back into the sheath.It was stated that due to that the device started to deploy and that it deployed in an unintended position.It was realized that after the device catheter was retracted through the sheath, the leading end separated from the device catheter.It was possible to remove the separated leading end with mosquito scissors through the valve of the sheath.The procedure was successfully completed.
Additional Manufacturer Narrative
B5: updated.The device was not returned for evaluation.The evaluation was completed using information and photos provided from the field sales associate.The device evaluation showed the following: the delivery catheter was broken at the trailing olive.The leading end had pulled out of trailing olive.The device had been deployed off the catheter.The deployment line for the device was extending out of the catheter deployment line lumen, indicating the deployment knob had not been pulled for the device.The findings from the evaluation are consistent with the physician¿s observations.The excluder instructions for use (ifu) clearly states: do not advance the device outside of the sheath while tracking it into position.Catheter breakage or premature deployment have occurred.Do not attempt to withdraw any undeployed endoprosthesis through the introducer sheath.The sheath and catheter must be removed together.Catheter breakage or separation or premature deployment have occurred.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.The cause for the catheter separation could not be determined from the currently available information.The attempt to withdraw an undeployed endoprosthesis through the introducer sheath may have contributed to the catheter separation.
Event or Problem Description
It was reported that the patient presented with an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.It was stated that during the advancement of the gore® excluder® aaa contralateral leg endoprosthesis (plc) positioning issues occurred and that the device was deployed in an inadequate position.It was reported that the patient presented with an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.It was stated that after a gore® excluder® aaa contralateral leg endoprosthesis (plc) was advanced outside of the sheath, it was tried to retract the device back into the sheath.It was stated that due to that the device started to deploy and it deployed in an unintended position.It was realized that after the device catheter was retracted through the sheath, the leading end separated from the catheter.It was possible to remove the separated leading end with a mosquito scissor through the valve of the sheath.The procedure was successfully completed.

• 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: 9795141
• Report Number: 3013164176-2020-00032
• Device Sequence Number: 19563486
• Product Code: MIH
• UDI-Device Identifier: 00733132618583
• UDI-Public: 00733132618583
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: PLC231400
• Device Catalogue Number: PLC231400
• Device Lot Number: 20685031
• Was Device Available for Evaluation?: No
• 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: 03/05/2020
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR