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

Model Number HGB161207A

Device Problems Stretched (1601); Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the patient was treated for an abdominal aortic aneurysm.The physician attempted to implant a gore® excluder® iliac branch endoprosthesis, but due to tortuosity of patient anatomy, was unable to deliver the device to the intended location.The physician attempted to remove the device, but in doing so, it became caught on the sheath.The device was finally removed, and the tube appeared stretched, but the olive did not detach.The physician completed the procedure using a vbx.The patient tolerated the procedure.The physician believes the event was caused by tortuosity of the patient's anatomy.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was returned for evaluation.The engineering evaluation stated: there was a gap between the leading olive and the undeployed stent graft.The polyimide guidewire lumen portion of the catheter was still bonded to the leading and trailing olives.The stent graft was still constrained on the catheter.There was damage on the trailing end of the leading olive consistent with the leading olive catching on the introducer sheath on withdrawal.The findings from the evaluation are consistent with the physician¿s observations.The cause for the device catching on the introducer sheath could not be determined from the currently available information.The reported tortuous anatomy may have contributed to the event.

Manufacturer Narrative

H1: type of report changed to: other.Upon receipt of the engineering evaluation, this event has been determined to be non-reportable, as there was no reported catheter breakage, shaft detachment, or olive separation occurring during the procedure.Therefore, medwatch (mfr.Report # 3013164176-2020-00050), is being retracted.

Manufacturer Narrative

H3: evaluation summary- the engineering evaluation stated; there was a gap between the leading olive and the undeployed stent graft.The polyimide guidewire lumen portion of the catheter was still bonded to the leading and trailing olives.The stent graft was still constrained on the catheter.There was damage on the trailing end of the leading olive consistent with the leading olive catching on the introducer sheath on withdrawal.The findings from the evaluation are consistent with the physician¿s observations.The cause for the device catching on the introducer sheath could not be determined from the currently available information.The reported tortuous anatomy may have contributed to the event.H6: results code 1 - corrected.H6: code 213 - review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code 22 - according to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), additional considerations for patient selection include but are not limited to the patient¿s anatomical suitability for endovascular repair.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and the vascular introducer sheaths and accessories necessary to deliver the endoprostheses.Further, the ifu cautions do not attempt to withdraw any undeployed endoprosthesis through the introducer sheaths.The sheath and undeployed device catheter must be removed together.Catheter breakage or separation or premature deployment have occurred and may result in potential patient harms.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 breakage or separation and reintervention resulting in potential patient harm.

• Brand Name: AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9941065
• MDR Text Key: 190314686
• Report Number: 3013164176-2020-00050
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635320
• UDI-Public: 00733132635320
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: HGB161207A
• Device Catalogue Number: HGB161207A
• Device Lot Number: 21444450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR