FDA Adverse Event
Malfunction
Summary report: N
HERO GRAFT
MDR report key: 5094958
·
Received September 22, 2015
Report
- Report Number
- 1063481-2015-00231
- Event Type
- Malfunction
- Date Received
- September 22, 2015
- Date of Event
- August 29, 2015
- Report Date
- August 27, 2015
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- DSY
- PMA / PMN Number
- K124039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
ACCORDING TO THE REPORT, A PATIENT RECEIVED A HERO GRAFT ON (B)(6) 2014 AND THROMBECTOMY WAS SUCCESSFULLY PERFORMED ON (B)(6) 2015. THIS REPORT SUBMITTED UNDER HERO 1001 BUT THE SCOPE OF THE INVESTIGATION WILL INCLUDE BOTH HERO 1001 AND 1002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 626939 | HERO GRAFT | VASCULAR GRAFT | DSY | CRYOLIFE, INC. | HERO 1001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |