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 2020-03-12 for CG FUTURE BAND 638RL30 manufactured by Medtronic Heart Valves Division.
[188623968]
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
[188623969]
Medtronic received information that this patient presented to the hospital following non-st segment myocardial infarction (nstemi). Upon admission the patient required an intra-aortic balloon pump (iabp). The patient was then taken for emergent mitral valve surgery and coronary artery bypass grafting (cabg). The patient's native mitral valve had a torn papillary muscle resulting in a flail anterior and posterior leaflet and severe regurgitation. A medtronic mitral annuloplasty ring was used in conjunction with neochords in an attempt to repair the native mitral valve. It was reported that initially the repair appeared to be successful, but after removing the cross-clamp, moderate to severe residual mitral regurgitation was noted. As a result, the annuloplasty ring was explanted and replaced with a non-medtronic bioprosthetic valve. The patient was supported via venous-arterial extracorporeal membrane oxygenation (ecmo) and the pre-existing iabp at the conclusion of the operation. No additional adverse patient effects related to a medtronic device were reported.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00766 |
| MDR Report Key | 9827582 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-01-28 |
| Date Added to Maude | 2020-03-12 |
| 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 | CG FUTURE BAND |
| Generic Name | RING, ANNULOPLASTY |
| Product Code | KRH |
| Date Received | 2020-03-12 |
| Model Number | 638RL30 |
| Catalog Number | 638RL30 |
| 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 | 2020-03-12 |