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

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546)

Patient Problems Rupture (2208); Unspecified Tissue Injury (4559)

Event Date 07/14/2021

Event Type  Injury  

Event Description

Edwards received notification from a field clinical specialist (fcs), that after deployment of a 23mm sapien 3 ultra edwards lifesciences valve in a 25mm edwards lifesciences mitroflow, the delivery system was removed and a 24mm true? balloon was placed across valves for a planned valve fracture.The patient was rapid paced and the true'" balloon inflated for approximately 10-12 seconds when the balloon ruptured.The patient was hemodynamically stable and echo showed no effusion.The true'" balloon was pulled down to the abdominal aorta when resistance was met.After observation under fluoro, it was felt that the true'" balloon had entered the 14 fr esheath.The true? balloon, wire, and sheath was pulled as a unit, when the scrub felt excessive resistance pulling and decided to stop.Attendings removed the true'" balloon and sheath as a unit.Upon removal, it was noted that the true'" balloon never entered the esheath and it had "broken the seam" of the esheath.The patient immediately became hemodynamically unstable.A reliant balloon was placed through the contralateral side and inflated above the iliac bifurcation and below the renals.The vascular surgeon was called and the patient was intubated.Chest compressions were started and the vascular surgeon performed an abdominal cutdown to clamp the aorta.The physician stated the iliac was visibly "shredded" and the aorta was ruptured at the site of the reliant balloon inflation.An ecmo was attempted without success.The patient's death was called in the room.It was thought that the iliac artery injury was related to the withdrawal difficulties.(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): UNKNOWN
• MDR Report Key: 17523141
• MDR Text Key: 321082558
• Report Number: MW5130089
• 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: 08/05/2021

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