MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-28 for SHILEY LSLM 33 N/A manufactured by Shiley.
[164]
Patient had a paravalvular leak in the mitral portion. The valve appeared to be calcified on small areas of leaflets but appeared to be functioning well. Aortic valve was replaced due to agedevice 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: none or unknown. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor, invalid data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 226 |
| MDR Report Key | 226 |
| Date Received | 1992-01-28 |
| Date of Report | 1992-01-09 |
| Date of Event | 1992-01-06 |
| Date Facility Aware | 1992-01-06 |
| Report Date | 1992-01-09 |
| Date Reported to FDA | 1992-01-09 |
| Date Reported to Mfgr | 1992-01-06 |
| Date Added to Maude | 1992-04-13 |
| 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 | SHILEY |
| Generic Name | MITRAL IONESCU SHILEY LOW PROFILE VALVE |
| Product Code | ISP |
| Date Received | 1992-01-28 |
| Model Number | LSLM 33 |
| Catalog Number | N/A |
| Lot Number | NA |
| ID Number | 33 MM |
| Device Availability | Y |
| Device Age | 01-MAY-84 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 222 |
| Manufacturer | SHILEY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-01-28 |