MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for SJM? MECHANICAL HEART VALVE manufactured by St. Jude Medical, Inc. (cs-woodridge).
[187560487]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[187560488]
Reference manufacturing report number 3008452825-2020-00162. On an unknown date, an abbott mechanical aortic valve was implanted. On (b)(6) 2015, mechanical valve was explanted due to stenosis that led to obstruction of flow and was replaced with a 21mm trifecta valve. Pannus was observed on the mechanical valve and calcification was also observed on the native aorta at left sinus level just above the left common trunk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007113487-2020-00005 |
| MDR Report Key | 9886653 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-26 |
| 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, INC. (CS-WOODRIDGE) |
| Manufacturer Street | 177 EAST COUNTY ROAD B |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | 2020-03-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) |
| Manufacturer Address | 177 EAST COUNTY ROAD B ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-26 |