FDA Adverse Event
Death
Summary report: N
MEDTRONIC EVOLUT TRANSCATHETER AORTIC VALVE
MDR report key: 19937852
·
Received August 6, 2024
Report
- Report Number
- MW5158126
- Event Type
- Death
- Date Received
- August 6, 2024
- Date of Event
- July 12, 2024
- Report Date
- August 5, 2024
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT HAD A BAILOUT PROCEDURE WITH A MEDTRONIC (NON-(B)(6)) EVOLUT; AFTER SEVERAL RECAPTURES, THE PATIENT CODED ON THE TABLE. A 29MM SAPIEN 3 VALVE WAS THEN IMPLANTED IN THE NATIVE AORTIC POSITION VIA TRANSCAROTID APPROACH. POST TAVR, THE PATIENT HAD MULTIPLE COMPLICATIONS FROM THE PROLONGED CPR (CARDIOPULMONARY RESUSCITATION), TRACHEOSTOMY, PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE PLACEMENT, PERMANENT PACEMAKER, MULTIPLE PRESSORS FOR BEING IN SHOCK, AND NEW DIALYSIS. THE PATIENT PASSED AWAY AFTER A PROGRESSIVE DECLINE. THERE WAS NO ALLEGATION OF AN (B)(6) DEVICE DEFICIENCY. 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 |
|---|---|---|---|---|---|---|---|
| 1636139 | MEDTRONIC EVOLUT TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |