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

Catalog Number	PLA280300
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: patient medications include toprol, synthroid, nitroglycerin, zocor, lasix, and niacin.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Engineering evaluation findings: the gore® excluder® aortic extender component was received by gore from the facility and an engineering evaluation was performed.The device was returned with the endoprosthesis deployed off the delivery catheter.During investigation, it was confirmed that the deployment line had broken at the deployment knob.Visual examination of the deployment line showed the length of the deployment line was longer than the catheter.Engineering also noted kinks in the deployment line from where it was part of the stitching of the constrained sleeve.The deployment line appeared to have broken at only one location at the deployment knob, and the broken end of the line showed no fraying or hairing.The findings from the evaluation were consistent with the reported procedural observations.However, the cause for the break in the deployment line could not be determined by the currently available information.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with a gore® excluder® aortic extender component to treat a proximal type i endoleak from a previously implanted non-gore manufactured stent graft.According to the report, no resistance or other notable issues during catheter advancement were reported.When the deployment knob was pulled, the deployment line was reportedly broken.The physician was reportedly able to successfully complete the deployment, and the endoleak was resolved.The patient tolerated the procedure with no adverse events.
Additional Manufacturer Narrative
Date of implant corrected to (b)(6) 2018.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with a gore® excluder® aortic extender component to treat a proximal type i endoleak from a previously implanted non-gore manufactured stent graft.According to the report, no resistance or other notable issues during catheter advancement were reported.When the deployment knob was pulled, the deployment line was reportedly broken.The physician was reportedly able to successfully complete the deployment, and the endoleak was resolved.The patient tolerated the procedure with no adverse events.

• 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: 8289818
• Report Number: 3013164176-2019-00011
• Device Sequence Number: 16632525
• Product Code: MIH
• UDI-Device Identifier: 00733132618781
• UDI-Public: 00733132618781
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 05/31/2020
• Device Catalogue Number: PLA280300
• Device Lot Number: 16359894
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/16/2019
• 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: 01/30/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 96