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

Model Number ETBF3216C166E

Device Problems Kinked (1339); Occlusion Within Device (1423); Activation, Positioning or Separation Problem (2906)

Patient Problems Unspecified Infection (1930); Occlusion (1984); Injury (2348)

Event Date 06/12/2014

Event Type  Injury  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7518042
• MDR Text Key: 108374225
• Report Number: 2953200-2018-00713
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00613994990990
• UDI-Public: 00613994990990
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2016
• Device Model Number: ETBF3216C166E
• Device Catalogue Number: ETBF3216C166E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 05/18/2018
• Date Device Manufactured: 03/13/2014
• 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): Required Intervention
• Patient Age: 72 YR