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

Model Number AB46

Device Problems Difficult to Remove (1528); Compatibility Problem (2960)

Patient Problem Injury (2348)

Event Date 07/08/2015

Event Type  Injury  

Event Description

An endurant stent graft system was implanted in a patient for the endovascular treatment of a 5.5x5.4mm abdominal aortic aneurysm on (b)(6) 2015.The proximal neck was 22-24mm in diameter and 25mm in length.The left common iliac artery was 17-14-13-12-10mm in diameter and the right common iliac artery was 12-11-10-9mm in diameter.The right external iliac artery measured 4.5-6mm in diameter and the left external iliac artery measured 5.5-6mm in diameter.It was reported that during the index procedure a reliant balloon was selected for use.After the physician successfully ballooned the proximal seal zone in the bifurcated stent graft, the balloon was fully deflated and retracted to balloon the contralateral limb/main body overlap in the "gate" segment.While the balloon was entering the gate segment, the physician visualized the proximal limb markers/proximal bare stents being pulled distally within the gate.The physician immediately stopped retracting the balloon, advanced it proximally, recognizing that the deflated balloon material had likely snagged on a proximal bare stent, pulling it distally.By rotating the balloon while slowly retracting the balloon catheter, the physician was able to remove the balloon without further moving the limb.An endurant ii 16x16x82 limb was then implanted within the gate segment to achieve adequate overlap seal between the bifurcated stent graft and the 16x13x124 contralateral iliac limb.The final angiogram confirmed adequate overlap seal was achieved and no presence of an endoleak.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

(b)(4).

• 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: 4956808
• MDR Text Key: 6640197
• Report Number: 2953200-2015-01197
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB46
• Device Catalogue Number: AB46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2015
• 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: 00068 YR