MAUDE Adverse Event Report: MEDTRONIC IRELAND UNK-CV-SR; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Injury (2348); Claudication (2550)

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; limb graft occlusion following endovascular aortic repair: incidence, causes, treatment and prevention in a study cohort guoquan wang, shuiting zhai, tianxiao li, xuan li, danghui lu, bo wang, dongbin zhang, shuaitao shi, zhidong zhang, kai liang, kewei zhang, xiaoyang fu, kun li and weixiao li doi: 10.3892/etm.2017.4658.If information is provided in the future, a supplemental report will be issued.

Event Description

An unknown medtronic bifurcated stent graft system was implanted in a patient for the endovascular treatment of a ruptured abdominal aortic aneurysm.It was reported approximately 3 months post the index procedure the patient presented with claudication and ct confirmed right limb occlusion of the stent graft.Intervention was completed where stenting and a fem fem bypass was performed.Antiplatelet medication was also administered to treat the event.The cause of the event was assessed as device related.No additional clinical sequalae were reported and the patient is fine.

Manufacturer Narrative

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

• Brand Name: UNK-CV-SR
• 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: 7647579
• MDR Text Key: 112701197
• Report Number: 2953200-2018-00909
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 10/24/2018
• 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: 64 YR