MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-22 for HANCOCK 11 PORCINE HEART VALVE, SIZE TI 33M12J5378 manufactured by Medtronic.
[4411437]
On (b)(6) 2014, a (b)(6) year old female patient was taken to the operating room for mitral and tricuspid valve surgery. During surgery, upon the surgeon seating the 33-hancock ii mitral prosthesis, the surgeon could see disruption of leaflets from the sewn ring. Because of this, the prosthesis was not seated and it was removed. The prosthesis was replaced with a 231 bovine pericardial valve and this prosthesis was successfully seated with good apposition on the annulus. The procedure was completed and the patient was transferred to the cardiac surgery icu for routine postoperative care. Site was subsequently discharged on (b)(6) 2014. There was no adverse event to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036325 |
| MDR Report Key | 3840199 |
| Date Received | 2014-05-22 |
| Date of Report | 2014-05-22 |
| Date of Event | 2014-03-20 |
| Date Added to Maude | 2014-06-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANCOCK 11 PORCINE HEART VALVE, SIZE TI |
| Generic Name | HANCOCK 11 PORCINE HEART VALVE, SIZE TI |
| Product Code | DTI |
| Date Received | 2014-05-22 |
| Returned To Mfg | 2014-04-11 |
| Model Number | 33M12J5378 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-22 |