MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for MITRO VALVE manufactured by .
[99185038]
Pt was in surgery for "high risk" re-do aortic valve replacement after receiving mitroflo 23mm valve in 2012, per dr (b)(6). Pt did not sustain blood pressures in attempt to come off cardio-pulmonary bypass in several attempts. Pt died in operating room after incision was closed. Pt's family did not wish to attempt mechanical support. On (b)(6) 2017 we had a pt who had a mitroflow valve dysfunction which lead to another surgery that was completed by dr. Rl solutions was filed and the device was sequestered from pathology and given to safety and security. (b)(6) brought to my attention that on (b)(6) 2017 we had a pt who had to have a mitroflow valve removed (placed in 2012). According to dr (b)(6)'s note, the mitroflow aortic valve leaflets had severe calcification involving all 3 cusps and the left and right cusps were fused. This pt ended up dying in the operating room. An rl solutions has been completed and i sequestered the valve from pathology and gave it to safety and security as well. This is the 2nd pt in 90 days that we have operated on to remove this kind of valve. I asked for assistance in wha...
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7237925 |
| MDR Report Key | 7237925 |
| Date Received | 2018-02-02 |
| Date of Report | 2018-01-23 |
| Date of Event | 2017-07-20 |
| Date Facility Aware | 2017-07-28 |
| Report Date | 2018-01-23 |
| Date Reported to FDA | 2018-01-23 |
| Date Added to Maude | 2018-02-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MITRO VALVE |
| Generic Name | MITRO VALVE |
| Product Code | LWR |
| Date Received | 2018-02-02 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Brand Name | MITRO VALVE |
| Generic Name | MITRO VALVE |
| Product Code | DTI |
| Date Received | 2018-02-02 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-02-02 |