FDA Adverse Event
Injury
Summary report: N
CORMATRIX ECM FOR CAROTID REPAIR
MDR report key: 4143087
·
Received September 23, 2014
Report
- Report Number
- 3005619880-2014-00052
- Event Type
- Injury
- Date Received
- September 23, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 25, 2014
- Manufacturer
- CORMATRIX CARDIOVASCULAR, INC.
- Product Code
- DXZ
- PMA / PMN Number
- K111187
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. NO SAMPLE WAS RETURNED FOR EVALUATION.
Description of Event or Problem · 1
ON (B)(6) 2014, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR CAROTID REPAIR. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT THE CORMATRIX ECM FOR CAROTID REPAIR WAS USED FOR CAROTID ENDARTERECTOMY ANGIOPLASTY ON (B)(6) 2014. APPROXIMATELY 2 WEEKS LATER, THE PATIENT EXPERIENCED A PSEUDOANEURYSM AND THE PATCH WAS REMOVED ON (B)(6) 2014. NO GLUES WERE USED DURING THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591291 | CORMATRIX ECM FOR CAROTID REPAIR | PATCH, PLEDGET, INTRACARDIAC, PETP | DXZ | CORMATRIX CARDIOVASCULAR, INC. | CMCV-006-606 | M14C1037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |