MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-24 for SJM MASTERS SERIES MECHANICAL HEART VALVE 31MJ-501 manufactured by St. Jude Medical Puerto Rico, Inc..
[146091395]
An event of improper leaflet function was reported. Morphological and hydrodynamic examination indicated the valve met abbott specifications. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally. This test ensures proper leaflet coaptation and hemodynamic performance. The cause of the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[146091396]
On (b)(6) 2019, a 31mm masters valve was implanted in a (b)(6) male. Following implant, an echo revealed improper leaflet function and the patient was reported to be hemodynamically unstable. The valve was exchanged for another 31mm masters valve (serial number: (b)(4)) and the patient is reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648612-2019-00035 |
| MDR Report Key | 8641223 |
| Report Source | FOREIGN |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-24 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2018-02-22 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL PUERTO RICO, INC. |
| Manufacturer Street | P.O. BOX 998 LOT 20 B ST. |
| Manufacturer City | CAGUAS, PUERTO RICO 00725 |
| Manufacturer Postal Code | 00725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SJM MASTERS SERIES MECHANICAL HEART VALVE |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2019-05-24 |
| Model Number | 31MJ-501 |
| Catalog Number | 31MJ-501 |
| Lot Number | 6332997 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL PUERTO RICO, INC. |
| Manufacturer Address | P.O. BOX 998 LOT 20 B ST. CAGUAS, PUERTO RICO 00725 00725 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-24 |