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

Catalog Number	PLL161207
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The gore® excluder® iliac extender component pll161207 / 16460763 was returned to gore and an egineering evaluation was performed.It was found that the device was returned with the endoprosthesis still on the delivery catheter.The deployment knob was not present on the delivery catheter.The deployment knob with a length of deployment line was not returned for evaluation.The deployment line was frayed and broken near the trailing olive.There were some curls at the end of the deployment line where it had broken.The deployment line loop at the leading end had been pulled back 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 findings from the evaluation are consistent with the physician¿s observations.The cause for the break in the deployment line could not be determined by the currently available information.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, this patient underwent endovascular treatment for an abdominal aortic aneurysm as well as bilateral iliac artery aneurysms and was therefore treated with gore® excluder® aaa endoprostheses.During the procedure, a gore® excluder® trunk-ipsilateral leg component rlt261418 was extended with a gore® excluder® iliac extender component pll161207 to intentionally cover the patient's left and previously coiled, hypogastric artery.During the attempt to deploy the pll161207 component, the deployment line was perceived to have detached from the deployment knob and was considered broken.The un-deployed device was removed from the patient and the procedure was concluded as planned with a new endoprosthesis.

• 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: 8180346
• Report Number: 3013164176-2018-00124
• Device Sequence Number: 1734871
• Product Code: MIH
• UDI-Device Identifier: 00733132618798
• UDI-Public: 00733132618798
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 11/20/2018

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: 06/29/2020
• Device Catalogue Number: PLL161207
• Device Lot Number: 16460763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2018
• 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
• Patient Age: 84 YR
• Patient Weight: 87