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 2020-03-26 for MOSAIC AORTIC BIOPROSTHETIC HEART VALVE 30519 manufactured by Medtronic Heart Valves Division.
[186529734]
Citation: paparella d et al. Minimally invasive surgical versus transcatheter aortic valve replacement: a multicenter study. Int j c ardiol heart vasc. 2019 apr 28;23:100362. Doi: 10. 1016/j. Ijcha. 2019. 100362. Earliest date of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without the return of the product, no definitive conclusion can be made regarding the clinical observations. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186529735]
Medtronic received information via literature regarding a comparison of the outcomes in patients who either underwent minimally invasive surgical aortic valve replacement (mini-savr) or transcatheter aortic valve implantation (tavi). All data were retrospectively collected from ten centers between january 2011 and december 2016. The overall study population included 2,904 patients (2,407 mini-savr; 497 tavi) and was predominantly male with a mean age of 74 years. Of those, 453 were implanted with medtronic corevalve transcatheter aortic valves and an unidentified number of mini-savr patients were implanted with medtronic hancock ii or mosaic surgical aortic valves. No serial numbers were provided. Among all patients, the 30-day mortality rate was 1. 8% (51 patients). Multiple manufacturers were involved in the study and no further details about the deaths were provided. Based on the available information, medtronic product was not directly associated with the deaths. Among all patients, adverse events included: permanent pacemaker implantation, stroke (disabling or non-disabling), reopening for bl eeding/complications, wound infection, atrial fibrillation, re-intubation, tracheostomy, blood transfusion, and low cardiac output. Based on the available information, medtronic product may have been associated with the adverse events. No additional adverse patient effects or product performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00969 |
| MDR Report Key | 9885309 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-04-28 |
| Date Mfgr Received | 2020-03-18 |
| 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 | 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 | MOSAIC AORTIC BIOPROSTHETIC HEART VALVE |
| Generic Name | HEART-VALVE, REPLACEMENT |
| Product Code | DYE |
| Date Received | 2020-03-26 |
| Model Number | 30519 |
| Catalog Number | 30519 |
| 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 | 2020-03-26 |