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 2020-03-25 for SJM? MECHANICAL HEART VALVE CVD0040 manufactured by St. Jude Medical Puerto Rico, Inc..
[187083200]
Multiple events were reported through a research article, which included paravalvular leakage, regurgitation, perforation, obstructed leaflets and a number of patient outcomes including death. 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
[187083201]
It was reported that a study was conducted where medical records from january 2008 to december 2018 for 25 mitral valve patients, including 4 abbott mechanical heart valves, requiring reoperation were collected. The majority of mitral valve dysfunction were paravalvular leaks, open - closure dysfunction, and perforation. Two patients died of cardiac causes before reoperation (one died in the hospital due to malignant arrhythmia, the other self-discharged due to financial issues and died of heart failure after 22 days) and an unknown number of patients required blood transfusions. Post-operative complications included cardiac dysfunction, arrhythmia, sepsis, pulmonary infection, gastrointestinal bleeding, cerebral hemorrhage, chronic renal dysfunction, and surgical hemorrhage. Five (5) patients died after reoperation from cardiac dysfunction, septic shock, and self-discharge. No abbott devices caused any deaths. Manufacturer report number: 2648612-2020-00031.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648612-2020-00032 |
| MDR Report Key | 9878540 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| 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 | 2020-03-25 |