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

Model Number ESBF3214C103E

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ischemia (1942); Occlusion (1984); Reaction (2414)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: etlw1610c156e sn (b)(4), expiration date: 2018-05-20, udi # (b)(4), etlw1613c156e sn (b)(4), expiration date: 2018-02-03.Additional patient codes: (b)(4).

Event Description

An endurant iis stent graft system was implanted in a patient for the endovascular treatment of the pre-operative rupture of a 44x60 cm abdominal aortic aneurysm.It was reported that the on the same day as the implant procedure, the patient was taken to the or with bilateral occlusions from the external iliac arteries all the way down.It was noted that the patient either had the bilateral occlusions from another manufactures closure system cinching down the vessels too much; or, the patient had onset of heparin induced thrombocytopenia (hit).It was further noted that the stent graft itself was fully patent and the implant procedure was a technical success with no endoleaks.Two days after the procedure the patient was doing poorly and was on a ventilator with multi-organ failure likely due to the hit.Three days post-procedure the patient had not improved and a below the knee amputation was performed due to the occlusion and ischemia.The physician stated that the cause of the event was anatomy related; specifically, the patient was allergic to heparin.No additional clinical sequelae were reported and the patient is being monitored by the physician.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6687794
• MDR Text Key: 79116917
• Report Number: 2953200-2017-01070
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439962
• UDI-Public: 00643169439962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2019
• Device Model Number: ESBF3214C103E
• Device Catalogue Number: ESBF3214C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/05/2017
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR