FDA Adverse Event
Injury
Summary report: N
COVERED C-P STENT
MDR report key: 17527533
·
Received August 12, 2023
Report
- Report Number
- MW5134465
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- January 17, 2012
- Manufacturer
- NUMED, INC
- Product Code
- PNF
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS FOLLOWING VALVE IMPLANT, FLUOROSCOPY CONFIRMED THAT A NON-MEDTRONIC (MANUFACTURER NUMED INC.) SINGLE WIRE COVERED C-P STENT FRAGMENT EMBOLIZED TO THE RIGHT PULMONARY ARTERY. NO INTERVENTION WAS DONE AND THE PATIENT WILL BE FOLLOWED UP IN 6 MONTHS. 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 |
|---|---|---|---|---|---|---|---|
| 2182599 | COVERED C-P STENT | AORTIC STENT | PNF | NUMED, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |