MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-11 for SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND 700FC27 manufactured by Medtronic Heart Valves Division.
[182594333]
Product analysis: no product was returned. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182594434]
Medtronic received information that during the repair of the patient's native mitral valve due to severe regurgitation, the native valve was noted to have diminutive leaflets as well as leaflet perforation following what appeared to be healed endocarditis. The surgeon performed various suturing repairs to the mitral valve, but the valve still had regurgitation. Subsequently, this 27mm mitral annuloplasty band was implanted. It was reported that the regurgitation improved, however, residual regurgitation remained. As such the 27mm band was explanted and replaced with a 25mm band of the same model. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00429 |
| MDR Report Key | 9691266 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-10 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-11 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Street | 1851 E DEERE AVE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND |
| Generic Name | RING, ANNULOPLASTY |
| Product Code | KRH |
| Date Received | 2020-02-11 |
| Model Number | 700FC27 |
| Catalog Number | 700FC27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |