MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-30 for SJM MECHANICAL HEART VALVE (UNKNOWN) CVD0039 manufactured by St. Jude Medical Puerto Rico, Inc..
[187714011]
As reported in a research article, a patient had stenosis, increased gradient, and an immobile leaflet due to a thrombus which resolved after treatment. 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
[187714013]
It was reported through an article (titled - case report of successful low-dose, ultra-slow infusion thrombolysis of prosthetic mitral valve thrombosis in a high risk patient after redo-mitral valve replacement) that a patient underwent a mitral valve replacement with a 25mm mechanical prosthesis because of recurrent moderate to severe mitral regurgitation after mitral valve repair in the same year due to symptomatic severe primary mitral regurgitation of (post-) inflammatory etiology. Seven (7) months post implant, the patient presented to the emergency department with dyspnea, chest pain, and hemoptysis. Imaging revealed increased gradient with impaired movement of one of the prosthesis discs, severe stenosis, a prosthetic valve thrombosis. A therapy with diuretics and iv unfractionated heparin was initiated. The thrombus and disc motion were resolved on the next day, with pressure gradient returning to the baseline value. The patient was reported to be stable at discharge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648612-2020-00042 |
| MDR Report Key | 9901353 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-30 |
| 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 (UNKNOWN) |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2020-03-30 |
| Model Number | CVD0039 |
| Catalog Number | CVD0039 |
| 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 | 2020-03-30 |