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

Model Number AB46

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 50 mm in diameter abdominal aortic aneurysm.It was reported that after implant of the bifurcate stent graft and the contralateral limb the physician performed a kissing ballooning procedure with two reliant balloons.At the angiographic control an endoleak was observed, there was a type iii endoleak as the guidewire was able to be passed through the stent graft.The physician implanted an additional endurant limb within the ipsilateral leg of the bifurcate to cover the hole, but the angiographic control still shows the presence of the endoleak, however, smaller compared to the initial situation.The physician finally decided to extend up to the bifurcation with an endurant stent graft.At the final angiography the endoleak was later but still unresolved.It is possible that the bifurcate may have been damaged during the kissing balloon procedure, due to the calcium presence.A 20 cc syringe was used to inflated the balloons with 50% contrast and 50% saline solution.It is unknown how much fluid was injected.The balloon was inflated once in each position from the proximal neck down to the distal landing zone, always inside the graft fabric.The physician ballooned with normal pressure.The patient will be monitored.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 CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5324487
• MDR Text Key: 34938175
• Report Number: 2953200-2015-02400
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2017
• Device Model Number: AB46
• Device Catalogue Number: AB46
• Device Lot Number: 0007804322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Date Device Manufactured: 10/28/2015
• 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 Age: 00077 YR