FDA Adverse Event
Death
Summary report: N
Z-MED
MDR report key: 17525750
·
Received August 12, 2023
Report
- Report Number
- MW5132691
- Event Type
- Death
- Date Received
- August 12, 2023
- Report Date
- April 20, 2016
- Manufacturer
- B. BRAUN
- Product Code
- OZT
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF A 22 MM Z-MED BALLOON FOR A POST IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) A RUPTURE IN THE SINUS OF VALSALVA OCCURRED. PER THE PHYSICIAN, THE MINERALIZED NON CORONARY CUSP MADE CONTACT WITH THE MINERALIZED SINUS OF VAISAIVA DURING THE BALLOON AORTIC VALVULOPLASTY, AND RESULTED IN THE RUPTURE. SUBSEQUENTLY, THE PATIENT EXPIRED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 762961 | Z-MED | BALLOON AORTIC VALVULOPLASTY | OZT | B. BRAUN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |