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

Catalog Number	PLC121400
Medical Device Problem Codes	Separation Failure (2547); Activation Failure (3270)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release specifications.The imaging could not be performed as the images were not available.The device was returned, the engineering evaluation is undergoing.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient was implanted with gore® excluder® aaa endoprosthesis to treat abdominal aortic aneurysm.The physician advanced the device to the target lesion and initiated the deployment line.However, the entire deployment line was pulled out and the endoprosthesis could not be expanded.Both the endoprosthesis and delivery system were retracted out of the patient.The physician used another new gore® excluder® aaa endoprosthesis, and deployed successfully without any reported issue to the patient.The deployment line was broken when the device was checked.
Additional Manufacturer Narrative
H6: code1 213 - the images were not available, the imaging evaluation could not be performed.The device was returned and the engineering evaluation was performed on the device.The evaluation results stated that the device was returned with the endoprosthesis still on the delivery catheter.The deployment knob had been pulled out of the delivery catheter.A length of deployment line was still attached to the deployment knob.The length of the deployment line was lined up with the catheter.The end of the deployment line met up with the other broken end that was still attached to the undeployed device.The deployment line was frayed and broken approximately halfway to the leading end of the constrained endoprosthesis.The deployment line loop at the leading end had been pulled out indicating that the deployment line had been partially pulled prior to the deployment line breaking.The end of the deployment line was pulled to see if there were any obstructions to deployment.There were no difficulties pulling the deployment line.The device deployed successfully when pulling the broken deployment line.The findings from the evaluation are consistent with the physician¿s observations.The likely cause for the break in the deployment line could not be determined by 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: 9248391
• Report Number: 3013164176-2019-00139
• Device Sequence Number: 1864852
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: 00733132618644
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2022
• Device Catalogue Number: PLC121400
• Device Lot Number: 20245813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• 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: 10/28/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR