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

Catalog Number	PLL161007
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During the case a contralateral leg component (plc121400/20569329) was implanted.An iliac extender component (pll161007/1878556) was needed to complete appropriate coverage from the contralateral leg component into the left external iliac artery.Upon removal of the delivery catheter, the olive tip and approximately 3-4" of the polyimide tubing separated from the rest of the delivery catheter.The physician noted resistance as the olive tip was being pulled into the sheath (dsf1833/unk).An audible sound was heard just as the catheter popped back into the sheath.The catheter delivery system was removed.The broken portion of the catheter and the olive tip were still over the wire (boston scientific amplatz, 260cm,.035 in).The sheath was advanced over the olive tip.The sheath, wire, and catheter were pulled back simultaneously until the sheath and broken piece were outside the patient's body.Once the broken piece was determined by examination and fluoroscopy to be intact and out of the body, the case proceeded in the usual fashion.The delivery catheter and sheath will be sent to gore for evaluation.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data - the device was returned to gore for an engineering evaluation.The results showed the following: the delivery catheter was broken at the trailing olive.The leading end had pulled out of trailing olive.The inside of the trailing olive had imprints from the polyimide guidewire lumen.There was damage to the leading end of the introducer sheath.The findings from the evaluation are consistent with the physician¿s observations.The excluder instructions for use (ifu) clearly states: do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter separation and reintervention.The cause for the resistance removing the catheter was the leading olive catching on the leading end of the introducer sheath during catheter removal.The cause for the leading olive catching on the introducer sheath could not be determined with the available information.The force used to remove the device catheter through the introducer sheath when the reported resistance was felt may have contributed to catheter breakage, however the cause for the catheter breakage could not be determined from 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: 8867523
• Report Number: 3013164176-2019-00101
• Device Sequence Number: 19430580
• Product Code: MIH
• UDI-Device Identifier: 00733132618811
• UDI-Public: 00733132618811
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/13/2019

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: 11/01/2021
• Device Catalogue Number: PLL161007
• Device Lot Number: 18785556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• 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: 08/06/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR