MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON; CATHETER, PERCUTANEOUS

Model Number REL46

Device Problem Device Damaged by Another Device (2915)

Patient Problem Injury (2348)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that five months post index procedure the physician performed an angiogram during follow-up and it was determined that there was a type ib endoleak coming from the right limb in the common iliac artery.The physician stated the cause of the event is unknown.A 16/10/93 endurant stent graft was implanted to extend the limb.A balloon was then used, but pushed up on the limb and displaced it into the right common iliac artery.Ballooning was performed and another angiogram was performed.Another type ib was noticed.Another 10/10/82 endurant stent graft was used to extend into the right external iliac artery.Another ballooning and angiogram was performed and the endoleak was resolved.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: RELIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IR
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5206332
• MDR Text Key: 30578454
• Report Number: 2953200-2015-01919
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050038
• 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: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• 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: 00086 YR