MAUDE Adverse Event Report: B. BRAUN Z-MED; BALLOON AORTIC VALVULOPLASTY

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Unintended Deflation (4061)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, as the 23 mm z-med balloon was deflating, the balloon was pulled in the aortic direction and caught on the edge of the valve resulting in the valve dislodging into the sinus of vaisaiva (sov).Subsequently, the valve was snared into the ascending aorta and a second transcatheter bioprosthetic valve was implanted.No adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: Z-MED
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 17530615
• MDR Text Key: 321274942
• Report Number: MW5137533
• 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: 09/16/2016

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