MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PLC121400
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.As the device remains implanted, and the delivery catheter was not returned, no evaluation of the device could be performed.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that the patient had a previously implanted bifurcated stent with exoskeleton (type unknown).The previously implanted device was being relined with the gore® excluder® aaa system.Reportedly the trunk-ipsilateral leg component was successfully deployed.The contralateral gate was cannulated, and the contralateral leg component was advanced.Upon initiating deployment of the contralateral limb, the device reportedly deployed about 4cm and then stopped.It was noted that deployment stopped at the level of the flow divider of the previously implanted device.It was suspected that the deployment line was caught on the exoskeleton of the device.The deployment line was pulled with excessive force in an attempt to deploy the remaining constrained limb.Reportedly the deployment line broke.No further device deployment was noted.Ballooning was attempted multiple times without success.Reportedly access was gained through the patient's arm as a precautionary measure.The physician then pulled the catheter from the lower limb access site with excessive force.The attempt was successful, and the contralateral leg component deployed fully.The leading olive tip of the delivery catheter remained intact.The delivery system was successfully removed from the patient.The procedure was concluded.The final angiogram determined that the devices were placed successfully with full exclusion of the aneurysm.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
B.1.Updated - product problem.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8629917
• Report Number: 3013164176-2019-00057
• Device Sequence Number: 1655642
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: 00733132618644
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2022
• Device Catalogue Number: PLC121400
• Device Lot Number: 20268699
• 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: 05/21/2019
• Supplement Report FDA Received Date: 09/03/2019
• 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: Hospitalization; Other
• Patient Age: 84 YR
• Patient Weight: 104