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

Model Number	ETBF3216C166E
Medical Device Problem Codes	Kinked (1339); Occlusion Within Device (1423); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Unspecified Infection (1930); Occlusion (1984); Injury (2348)
Date of Event	06/12/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: the main component of the system.Other relevant device(s) are: product id: etlw1628c124e, serial/lot (b)(4), ubd: 21-apr-2016, (b)(4).Product id: etlw1613c124e, serial/lot (b)(4), ubd: 21-jun-2015, (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an unknown condition.It was reported by the patient's wife that the stent graft didn't open and that the physician has stated there was a kink in it.5 days after the index procedure, there was not sufficient blood flow to the patients left leg and a fem-fem bypass was performed.It was noted by the patients wife that blood flow problems to the patients legs continues, the patient is not healing and has an infection.The cause of the event is unknown.No additional clinical sequelae were reported and the patient is not doing well as per the complainant.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7518042
• Report Number: 2953200-2018-00713
• Device Sequence Number: 1225263
• Product Code: MIH
• UDI-Device Identifier: 00613994990990
• UDI-Public: 00613994990990
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 03/12/2016
• Device Model Number: ETBF3216C166E
• Device Catalogue Number: ETBF3216C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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: 72 YR