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

Model Number ESBF2814C103E

Device Problem Difficult To Position (1467)

Patient Problem Perforation of Vessels (2135)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An endurant iis stent graft system was planned to be implanted in a patient for treatment of a 50 mm abdominal aortic aneurysm.However, it was reported that, during the procedure the right external iliac was transected or dissected with the introduction and removal of the device three times.The physician was able to gain proximal control with vessel loops and a 16fr sheaths and completed the evar with a 28mm aui and limb, followed by bilateral femoral endarterectomies and a fem-fem bypass.The physician attributed the cause of the event to diseased external iliac arteries, along with a calcified distal aorta that inhibited the device from passing through the anatomy.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The distal tip was curved.Multiple kinks were observed along the stent graft cover.There was no further damage observed to the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7501815
• MDR Text Key: 107821371
• Report Number: 2953200-2018-00683
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: 00643169439979
• 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,Followup,Followup
• Report Date: 10/03/2018

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: 02/01/2020
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 07/25/2018; 08/08/2018
• Supplement Dates FDA Received: 07/26/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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: 70 YR
• Patient Weight: 97