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 2015-10-05 for MOSAIC AORTIC BIOPROSTHETIC HEART VALVE 305 manufactured by Medtronic Heart Valves Division.
[27505800]
(b)(4). Title: transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score? Matched case-control study citation: am heart j. 2012 dec;164(6):910-7 (doi: 10. 1016/j. Ahj. 2012. 09. 005) authors: azeem latib, mb chb, francesco maisano, md, letizia bertoldi, md, andrea giacomini, md, joanne shannon, md, micaela cioni, md, alfonso ielasi, md, filippo figini, md, kensuke tagaki, md, annalisa franco, md, remo daniel covello, md, antonio grimaldi, md, pietro spagnolo, md, gill louise buchannan, md, mauro carlino, md, alaide chieffo, md, matteo montorfano, md, ottavio alfieri, md, and antonio colombo, md date accepted by publisher used for event date.
Patient Sequence No: 1, Text Type: N, H10
[27505801]
Medtronic received information via literature review of a study performed to compare outcomes after transcatheter aortic valve replacement (tavr) and surgical aortic valve replacement (savr) in patients with severe symptomatic aortic stenosis. The study population included 405 patients (mean age 79. 8 years), 276 of which underwent tavr from november 2007 thru february 2011 and 129 of which un derwent savr from august 2003 thru june 2008. A propensity score matching based on clinical characteristics and surgical risk scores was then utilized to compare 222 patients (111 from each the tavr and savr groups). Of the 111 tavr patients, 41 received a medtronic transcatheter bioprosthetic valve (serial numbers not reported). Of the 111 savr patients, 26 received a medtronic surgical bioprosthetic valve (serial numbers not reported). Among all 222 matched patients, 16 total cardiovascular deaths (7 tavr; 9 savr) occurred within one year follow-up. No deaths were directly attributed to medtronic products. Among all 222 matched patients, peri-procedural and in-hospital adverse events included: 150 life-threatening/major bleeding complications (68 tavr; 82 savr), 38 acute kidney injury (9 tavr; 29 savr), 16 permanent pacemaker (13 tavr; 3 savr), 16 major vascular complications (tavr only), 4 repeated intervention for unspecified valve-related malfunction (3 tavr; 1 savr), and 2 surgical interventions (savr only). Adverse events up to one year post-implant included: 15 stroke/transient ischemic attack (5 tavr; 10 savr), and 2 myocardial infarction (savr only). The authors noted a significantly higher incidence of permanent pacemaker required for medtronic transcatheter bioprosthetic valves (10/41) as compared with non-medtronic transcatheter bioprosthetic valves (3/70). Apart from this statement, no other adverse events were directly attributed to medtronic products. No additional adverse patient effects were reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[28494891]
No device was returned and no unique device identifier (serial/lot) numbers were provided. Without unique device identifier information a review of the device history record could not be performed and root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[28494892]
Requests for additional information provided no further details.
Patient Sequence No: 1, Text Type: D, B5
[99336073]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025587-2015-01039 |
| MDR Report Key | 5128338 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2015-10-05 |
| Date of Report | 2015-10-09 |
| Date of Event | 2012-09-05 |
| Date Mfgr Received | 2015-10-09 |
| Date Added to Maude | 2015-10-05 |
| 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 | 2015-10-05 |
| Model Number | 305 |
| Catalog Number | 305 |
| 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 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-05 |