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

Model Number	ETLW1613C199E
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Rupture (2208)
Date of Event	10/11/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 90 mm abdominal aortic aneurysm.It was reported that the bifurcated stent graft was successfully implanted, however, the stent graft limb etlw1613c199e could not be tracked through the iliac artery.The physician then successful doddered a 12f sheath and a second attempt was made to track the device, but this was again unsuccessful.A 16f dilator was then successfully tracked through the iliac using the same doddering technique and a third attempt was made to track the device, but this was again unsuccessful.It was reported that after the delivery system was removed the patient¿s blood pressure dropped.Angiogram performed and an iliac rupture was noted.Three non-mdt covered stents were placed, but the patient continued to crash.An endurant aui device etuf2814c102e was then implanted inside the bifurcated stent graft and extended with an endurant stent graft limb etlw1613c156e.The patient remained unstable and the physician decided to convert to an open repair.The bleeding was controlled, a fem-fem bypass was carried out and the midline incision left open/packed.As per the physician, the cause of the event was due to the patient¿s torturous and calcified iliac arteries.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Additional information received: it was reported that the endurant iis bifurcated stent graft was not explanted during the open repair and remained implanted in the patient.It was also reported that the patient expired the next day.Per the physician the cause of death was related to rupture, the implant procedure and specifically the endurant device (b)(4) film evaluation summary: the cause of the reported iliac artery rupture occurring during implant of the iliac limb could not be determined from the pre-implant films provided.Image during implant were not available for review and an assessment of the reported vessel rupture could not be performed.The location (side) of the iliac rupture was not reported; however, both the left and right common iliac arteries were long and extensively calcified.Therefore, it is possible that implanting within the diseased iliac anatomy may have led to the limb positioning difficulties, iliac rupture, and subsequent implant of additional devices and open repair to eventually control the bleeding.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9196758
• Report Number: 9612164-2019-04382
• Device Sequence Number: 11500809
• Product Code: MIH
• UDI-Device Identifier: 00643169467705
• UDI-Public: 00643169467705
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: ETLW1613C199E
• Device Catalogue Number: ETLW1613C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: Death; Life Threatening; Required Intervention
• Patient Age: 74 YR