MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-10 for MOSAIC AORTIC BIOPROSTHETIC HEART VALVE 30525 manufactured by Medtronic Heart Valves Division.
[33259985]
(b)(4). Title: efficacy of stentless aortic bioprosthesis implantation for aortic stenosis with small aortic annulus citation: thorac cardiovasc surg 2015;63:446? 451 authors: takashi murashita, yukikatsu okada, hideo kanemitsu, naoto fukunaga, yasunobu konishi, ken nakamura, tadaaki koyama month and year of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.
Patient Sequence No: 1, Text Type: N, H10
[33259986]
Medtronic received information via literature review that a study was performed to investigate long-term impact of stentless aortic bioprosthesis on clinical outcomes compared with stented aortic bioprosthesis. The study population included 140 patients (predominantly female, mean age of 73 years), 69 of which were implanted with a medtronic stentless bioprosthesis (serial numbers not provided) and 71 of which were implanted with a medtronic stented bioprosthesis (serial numbers not provided). Among all patients three early deaths occurred due to low output syndrome (2) and stroke (1), and twelve late deaths occurred (four cardiac and eight non-cardiac) without causes provided. One of the late deaths due to congestive heart failure was deemed valve-related. Among all patients seven adverse events occurred which included: stroke (3), readmission for congestive heart failure (3) and structural valve deterioration requiring reoperation (1). No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[33349525]
Patient Sequence No: 1, Text Type: N, H10
[33349526]
Additional information received from the physician stated that medtronic product did not cause or contribute to a death or other adverse event, no serial number identifiers were available, and no product was available for return to medtronic.
Patient Sequence No: 1, Text Type: D, B5
[99334856]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025587-2015-01310 |
| MDR Report Key | 5287181 |
| Date Received | 2015-12-10 |
| Date of Report | 2015-12-10 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-12-10 |
| Date Added to Maude | 2015-12-10 |
| 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 | 2015-12-10 |
| 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 | 2015-12-10 |