MAUDE Adverse Event Report: MEDTRONIC TRUE BALLOON; BALLOON AORTIC VALVULOPLASTY

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2020

Event Type  Injury  

Event Description

As reported by the clinical specialist, during a tf tavr (viv case) a bard true balloon was used to post dilate the existing surgical valve.While inflating the balloon it ruptured.The rupture was substantial and the team tried to remove the balloon and balloon catheter through the esheath but the wings of the balloon got caught and would not let it pass.While pulling on the balloon it separated from the balloon catheter and was floating in the infra renal aorta.The physician had to snare the floating balloon in the infrarenal aorta and pulled out through a 16f non-edwards sheath.Once everything was successfully removed the implanter placed three viabahns in the right common iliac artery above the hypogastric.The end result for the patient was good and the patient went home today without incident.The vascular injury was caused by the wings of the bard true balloon not folding and thus not reentering the esheath.Images received by the fcs clearly show delamination of the sheath.The lot number of the device is unknown and the device was not retained for evaluation.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRUE BALLOON
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17535642
• MDR Text Key: 321154711
• Report Number: MW5142537
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: CATHETER, INTRODUCER