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

Model Number	RLT311415
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, the patient was treated for abdominal aortic aneurysm.A gore® excluder® aaa endoprosthesis featuring c3® delivery system was implanted and deployed successfully.When retracting the delivery catheter, the leading olive became stuck in the seal of the gore® dryseal sheath with hydrophilic coating.In the attempt to remove the catheter from the sheath, the delivery catheter separated approximately 3 inches distal to the leading olive.The patient tolerated the procedure.The physician has no opinion regarding the cause of the event.The device will be returned for evaluation.
Additional Manufacturer Narrative
B2: corrected ¿ intervention was not performed.H6: device code ¿ 2923 ¿ incorrect code.H6: method code ¿ 10 - added.H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.H6: conclusion code ¿ 4315 - added.H3: engineering evaluation summary - the trunk-ipsilateral leg component (rlt311415) delivery catheter was returned to gore for analysis.A visual inspection revealed a break in the polyimide shaft approximately 10 cm from the leading end of the catheter, with no damage to the leading olive being observed.Examination of the mid olive bond identified evidence of a polyimide break at the mid-olive.However, further examination of the broken polyimide did not reveal the cause of the break.A kink was observed approximately 14 cm from the end of the device, but this may have occurred during shipping.The evaluation of the returned device is consistent with the reported observations.However, as the sheath was not returned for examination, the reported observation that the leading olive became stuck in the seal of the sheath could not be confirmed.The cause for the delivery catheter separation could not be determined with the available information.

• 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: 10264928
• Report Number: 3007284313-2020-00171
• Device Sequence Number: 2951580
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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): 08/26/2020

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: 03/16/2023
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Device Lot Number: 21833615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• 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: 07/13/2020
• Supplement Report FDA Received Date: 10/15/2020
• 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: Required Intervention