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 2015-09-17 for MOSAIC AORTIC BIOPROSTHETIC HEART VALVE 30525 manufactured by Medtronic Heart Valves Division.
[26050377]
(b)(4). Title: early stenosis of an aortic porcine bioprosthesis due to thrombosis: case report and literature review citation: j thorac cardiovasc surg 2015;149:e83-6 (http://dx. Doi. Org/10. 1016/j. Jtcvs. 2015. 02. 039) authors: masahiro dohi, md, kiyoshi doi, md, phd, and hitoshi yaku, md, phd date of publish used for event date.
Patient Sequence No: 1, Text Type: N, H10
[26050378]
Medtronic received information via literature review of an article describing early stenosis and thrombosis of aortic bioprosthetic valves. The case report within the article did not reference medtronic products, however a table summary reference 18 medtronic surgical bioprosthetic valves from two device families (serial numbers not reported) noted with early thrombosis (excluding patients on anticoagulation or thrombolytic therapy). Per the table summary, the patients with medtronic valves had a mean age of 70. 5 years, and a mean time from implant to thrombosis occurrence of 40. 7 months. Of these 18 patients, all but four were noted as having undergone intervention to replace the thrombotic valve. No additional adverse patient effects were reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[27542974]
Conclusion: no device was returned and no unique device identifier numbers were provided. Based on the available information a review of the device history record could not be performed and root cause could not be identified.
Patient Sequence No: 1, Text Type: N, H10
[27542975]
Requests for additional information provided no further details.
Patient Sequence No: 1, Text Type: D, B5
[99333686]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025587-2015-00981 |
| MDR Report Key | 5084311 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-03-24 |
| Date Mfgr Received | 2015-09-29 |
| Date Added to Maude | 2015-09-17 |
| 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 STRUCTURAL HEART |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOSAIC AORTIC BIOPROSTHETIC HEART VALVE |
| Generic Name | TIMER, CLOT, AUTOMATED |
| Product Code | GKN |
| Date Received | 2015-09-17 |
| Model Number | 30525 |
| Catalog Number | 30525 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-09-17 |