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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device catheter of the gore® excluder® iliac extender component pll161207/18865617 has not yet been returned to gore for a device evaluation.However, the gore dryseal flex introducer sheath dsf(12/33)/unk also involved in this event as well as the deployed endoprosthesis have been returned and are currently being investigated.
Event or Problem Description
The following was reported to gore: on (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.Due to a partly aneurysmatic common iliac artery on the left patient side, it was decided to perform an extension reaching to the level of the iliac artery bifurcation.A gore® excluder® iliac extender component pll161207 was advanced to the intended location and reportedly deployed safely outside of the gore dryseal flex introducer sheath dsf(12/33).Following deployment, and for the first few centimeters, there were no problems retracting the device catheter but then severe resistance was met.To overcome the resistance, the attempt was made to retract the device catheter with force back into the sheath, realizing that the pll endoprosthesis, believed to have been released from the catheter during deployment, was also pulled back again into the sheath.This was confirmed by fluoroscopy imaging.To remedy the situation, it was decided to remove the sheath and retrieve from it the device catheter and the deployed pll device.Reportedly, a new sheath was subsequently advanced into the patient and a new stent graft was deployed at the intended location.The patient tolerated the procedure.
Additional Manufacturer Narrative
The delivery system comprising of the delivery catheter and the deployment knob with attached deployment line of the gore® excluder® iliac extender component (b)(4) were not returned to gore for an evaluation.Only the deployed stent graft and the gore dryseal flex introducer sheath dsf(12/33)/unk were available.An engineering evaluation was performed and the device evaluation showed that there was no damage to the leading end of the introducer sheath.The stent graft was fully deployed.No irregularities were noted on the deployed stent graft which were consistent with the stent graft being attached to the delivery catheter after deployment.The returned stent graft had some tape delamination on the distal end.The damage to the tape seen is not likely the cause of the reported catheter withdrawal interference.There were no irregularities seen in the deployment line stitch holes in the deployment sleeve.The deployment sleeve was detached at the distal end of the deployed device.The sleeve had been torn out of the suture attaching it to the stent graft.The suture was still intact attached to the stent graft.The sleeve was still attached to the deployed device at the proximal end.The physician¿s observation that the stent graft was still attached to the delivery catheter after deployment could not be confirmed with the currently available information.The cause for the catheter withdrawal interference could not be determined with the 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: 8932814
• Report Number: 3013164176-2019-00109
• Device Sequence Number: 13520227
• Product Code: MIH
• UDI-Device Identifier: 00733132618798
• UDI-Public: 00733132618798
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 11/25/2021
• Device Catalogue Number: PLL161207
• Device Lot Number: 18865617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• 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: 08/26/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: 82 YR