MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-20 for SJM? MECHANICAL HEART VALVE CVD0040 manufactured by St. Jude Medical Puerto Rico, Inc..
[184414495]
An event of regurgitation was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[184414497]
As reported in a research article, on an unknown date, a patient underwent mitral valve replacement with a 31-mm abbott mechanical heart valve. This procedure was complicated by mild paravalvular mitral regurgitation. Six months post - procedure, the patient presented with shortness of breath. Patient had a history of advanced type 1 myotonic dystrophy complicated by muscle weakness and recurrent falls, paroxysmal atrial tachycardia, bi-leaflet mitral valve prolapse with severe posteriorly directed mitral valve regurgitation, and non-ischemic cardiomyopathy. He expressed his desire for home hospice without intravenous therapies. A trial of probenecid therapy was proposed, intravenous milrinone was discontinued. He was discharged to inpatient hospice, and he discontinued all intravenous therapies. The patient expired 6 days after the second round of intravenous milrinone was stopped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648612-2020-00027 |
| MDR Report Key | 9861888 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-20 |
| 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 | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| 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 Country | RQ |
| Manufacturer Postal Code | 00725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SJM? MECHANICAL HEART VALVE |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2020-03-20 |
| Model Number | CVD0040 |
| Catalog Number | CVD0040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 RQ 00725 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2020-03-20 |