FDA Adverse Event
Injury
Summary report: N
CORMATRIX ECM FOR CARDIAC TISSUE REPAIR
MDR report key: 3060068
·
Received April 11, 2013
Report
- Report Number
- 3005619880-2013-00008
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 11, 2013
- Manufacturer
- CORMATRIX CARDIOVASCULAR, INC.
- Product Code
- DXZ
- PMA / PMN Number
- K063349
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR CARDIAC TISSUE REPAIR RESULTING IN A SURGICAL INTERVENTION FOR A HYPERTROPHIED PATCH. DETAILS OF THE EVENT ARE PROVIDED BELOW. IN LATE (B)(6) 2013, THE PATIENT UNDERWENT AN INTERRUPTED AORTIC ARCH REPAIR PROCEDURE WITH THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR. ON (B)(6) 2013, APPROXIMATELY SIX WEEKS FOLLOWING THE INITIAL PROCEDURE, THE PATIENT REQUIRED A REOPERATION DUE TO A GRADIENT OF 70 MMHG ON THE AORTA. UPON REOPERATION, THE PROXIMAL PART OF THE PATCH (APEX OF THE ARCH) WAS OBSERVED TO HAVE HYPERTROPHIED. THE SURGEON INDICATED THAT, FOLLOWING THE REOPERATION, THE PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155310 | CORMATRIX ECM FOR CARDIAC TISSUE REPAIR | PATCH, PLEDGET AND INTRACARDIAC, PETP | DXZ | CORMATRIX CARDIOVASCULAR, INC. | CMCV-004-404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |