MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-15 for 19 MM ST. JUDE PROTHESIS 460870 manufactured by St. Jude Medical Inc..
[15441617]
Physician reqlized valve leaflet was not functioning and patient was scheduled surgery to replace a 20 mm redtronic-hall valve on 1/22/93. At the time of the procedure, a mobile piece of calcium was wedged between the hinge mechanism of one of the st. Jude leaflets, preventing it from opening. Device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, none or unknown, other, leaflet. Conclusion: other. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5377 |
| MDR Report Key | 5377 |
| Date Received | 1993-03-15 |
| Date of Report | 1993-02-09 |
| Date of Event | 1993-01-22 |
| Report Date | 1993-02-09 |
| Date Reported to Mfgr | 1993-02-09 |
| Date Added to Maude | 1993-07-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 19 MM ST. JUDE PROTHESIS |
| Generic Name | AORTIC VALVE |
| Product Code | ISP |
| Date Received | 1993-03-15 |
| Catalog Number | 460870 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 5073 |
| Manufacturer | ST. JUDE MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-03-15 |