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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD TRUE BALLOON VALVULOPLASTY CATHETER; BALLOON AORTIC VALVULOPLASTY

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BARD TRUE BALLOON VALVULOPLASTY CATHETER; BALLOON AORTIC VALVULOPLASTY Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)
Event Type  Injury  
Event Description
Medtronic received information that following the implant of a transcatheter bioprosthetic valve, a 26mm bard true balloon damaged the commissure of the valve causing aortic regurgitation.Subsequently, a second transcatheter bioprosthetic valve was implanted.No adverse patient effects were reported.Pe (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
TRUE BALLOON VALVULOPLASTY CATHETER
Type of Device
BALLOON AORTIC VALVULOPLASTY
Manufacturer (Section D)
BARD
MDR Report Key17524400
MDR Text Key321135846
Report NumberMW5131347
Device Sequence Number1
Product Code OZT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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