FDA Adverse Event
Injury
Summary report: N
ADVANTA SST
MDR report key: 2963639
·
Received January 2, 2013
Report
- Report Number
- 1219977-2012-00135
- Event Type
- Injury
- Date Received
- January 2, 2013
- Report Date
- February 12, 2009
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- DSY
- PMA / PMN Number
- K010516
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED FOR EVALUATION. IT WAS A MISUNDERSTANDING OF WHICH END THE SLIDER GDS WAS ON AND THE DIAMETER DIFFERENCES WHEN THE ADVANTA SST IS LAID FLAT VERSUS IN A CIRCULAR (GRAFT LIKE) SHAPE.
Description of Event or Problem · 1
THE GRAFT DIDN'T TAPER AND WHEN IT WAS LAID FLAT IT MEASURED 10MM AT THE GDS CONNECTION UP UNTIL THE IMMEDIATE CONNECTION WHERE IT MEASURED 6MM (A SUDDEN TAPER OF LESS THAN 5MM IN LENGTH). THE PHYSICIAN DETACHED, REMOVED THE GRAFT AND THEN USED A 4-7.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1517 | ADVANTA SST | DSY | ATRIUM MEDICAL CORP. | 25042 | P411212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | HEPARINIZED THE GRAFT |