MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETLW1616C93E
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 55mm abdominal aortic aneurysm.It was reported that during the index procedure, the main body bifurcate stent graft implanted.The physician then proceeded to cannulate the contralateral limb.It was reported that after a few attempts to cannulate, the guide wire advanced up into the bifurcate stent graft and this was confirmed by pigtail flush.A retrograde type sheath injection was injected through the left sheath and a16x16x93 endurant limb was advanced into the bifurcated graft and was thought to be advancing in the contralateral side.After completing this deployment, the physician began to proceed with completing the deployment of the ipsilateral limb of the bifurcate stent graft, when it was noticed the the ipsilateral limb had auto- deployed.The physician then proceeded to remove the delivery system of the bifurcate and began using another retrograde sheath injection from the left groin.Another limb 16x 13 x 124 was chosen and while deploying, it was noticed that the left limb proximally looked abnormal and following completion of oblique projections from a fixed x-ray unit, it was found that this limb had deployed in the ipsilateral side of the bifurcate and not the left contralateral limb as originally thought.It was confirmed it that etlw1616c93e was the only device that was inaccurately deployed during the procedure.As a result, the physician decided to implant an aui stent graft into the patients right side extending into the bifurcate graft.The patients left common iliac artery was then occluded by the physician and a right to left fem-fem bypass was performed.As per the physician the cause of the event was misinterpretation of the x-ray imaging that were confirming the cannulation of the gate.No additional clinical sequalae were provided and the patient is fine.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10249167
• Report Number: 9612164-2020-02488
• Device Sequence Number: 2577092
• Product Code: MIH
• UDI-Device Identifier: 00643169467569
• UDI-Public: 00643169467569
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/09/2020
• 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
• Patient Age: 69 YR