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

Model Number	PLL161007
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, the patient presented with a type iii endoleak originating in a competitor's device.A gore® excluder® iliac branch endoprosthesis was implanted to treat the endoleak.The physician advanced the graft to the desired position.When the device was deployed, and the physician attempted to retract the delivery catheter, the device became stuck in the sheath.When the physician continued to remove the device from the sheath, the olive detached from the device.The physician deflated the sheath, and used forceps to remove the deployed device and olive from the patient.A second gore® excluder® iliac branch endoprosthesis was implanted using the same sheath.The device was implanted successfully, and the patient is doing fine.The physician had no opinion on the cause of the event, but the fsa suspected that the first device was deployed partially in the sheath.I was also reported that the common and external iliac arteries had significant tortuosity, and that the device had to be advanced through existing devices.
Additional Manufacturer Narrative
B5: describe event or problem - updated with additional information from completed engineering evaluation.
Event or Problem Description
On (b)(6) 2019, the patient presented with a type iii endoleak originating in a competitor's device.A gore® excluder® iliac branch endoprosthesis was implanted to treat the endoleak.The physician advanced the graft to the desired position.When the device was deployed, and the physician attempted to retract the delivery catheter, the device became stuck in the sheath.When the physician continued to remove the device from the sheath, the olive detached from the device.The physician deflated the sheath, and used forceps to remove the deployed device and olive from the patient.A second gore® excluder® iliac branch endoprosthesis was implanted using the same sheath.The device was implanted successfully, and the patient is doing fine.The physician had no opinion on the cause of the event, but the fsa suspected that the first device was deployed partially in the sheath.I was also reported that the common and external iliac arteries had significant tortuosity, and that the device had to be advanced through existing devices.The device was not returned for evaluation.The evaluation was completed using the information provided for the event.The following was reported for the event.The device was deployed in the desired position.When the physician attempted to retract the delivery catheter the device became stuck in the introducer sheath.The catheter separated when physician tried to remove the catheter from the sheath.The deployed device and leading end of the catheter (leading olive attached to the gold braided guidewire lumen) were pulled out of the introducer sheath using forceps after deflating the introducer sheath valve.The fsa suspected the device was deployed inside the sheath by accident.Without a physical sample to evaluate, the physician¿s observation that while removing the delivery catheter from the introducer sheath the olive detached from the device cannot be conclusively confirmed.The cause for the reported broken leading end of the catheter is consistent with the device being deployed inside the introducer sheath and forcibly removed from the sheath after deployment, however this cause could not be confirmed with the available information.
Additional Manufacturer Narrative
Updated h7.Updated conclusion codes.The ifu in place at the time of the procedure included the following relevant warnings: 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.

• Brand Name: AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9521534
• Report Number: 3013164176-2019-00181
• Device Sequence Number: 10844693
• Product Code: MIH
• UDI-Device Identifier: 00733132618811
• UDI-Public: 00733132618811
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: PLL161007
• Device Catalogue Number: PLL161007
• Device Lot Number: 19941419
• 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; Not provided
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/13/2020; 01/29/2020
• 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