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 07/07/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was inserted in a in a patient for the endovascular treatment of a 63mm diameter abdominal aortic aneurysm.The aortic neck was 23mm in diameter and 15mm in length with 10 degree angulation.It was reported that post implant the balloon pulled the bifur distal enough to create type 1 endoleak.This was immediately resolved with an aortic cuff.Per the physician the cause of the event was anatomy related (conical neck).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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6744907
• MDR Text Key: 81078183
• Report Number: 2953200-2017-01177
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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: 07/07/2017
• 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: 68 YR