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 04/21/2016

Event Type  Injury  

Event Description

An endurant ii stent graft system was implanted in the patient for the endovascular treatment of a 54 mm in diameter abdominal aortic aneurysm.It was reported that, during the index procedure, the endurant ii stent graft limb was dilated with a reliant balloon in order to address an observed stenosis.After aggressively ballooning the stenosis an angiogram was performed and an endoleak was discovered in the middle portion of the endurant ii limb located in the distal aorta.A pigtail catheter was used to reveal a tear in the graft material of the endurant ii limb and a type iii fabric endoleak was confirmed.The physician elected to implant another endurant ii limb across the tear and the endoleak was resolved.Per the physician, the cause of the type iii fabric endoleak was due the aggressive ballooning during the procedure.No additional sequelae were reported and the patient is fine.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• 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: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5654668
• MDR Text Key: 45192870
• Report Number: 2953200-2016-01031
• 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,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• 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: 04/21/2016
• 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: 76 YR