FDA Adverse Event
Malfunction
Summary report: N
NEUROFORM MICRODELIVERY STENT SYSTEM
MDR report key: 916389
·
Received September 17, 2007
Report
- Report Number
- 6000078-2007-00233
- Event Type
- Malfunction
- Date Received
- September 17, 2007
- Date of Event
- September 3, 2007
- Report Date
- September 5, 2007
- Manufacturer
- NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
- Product Code
- NJE
- PMA / PMN Number
- H02002/S4
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO REPORTED PATIENT COMPLICATIONS AND PATIENT CONDITION WAS GOOD. STENT LOCATION IS UNKNOWN; HOWEVER, RETURN OF THE DEVICE IS EXPECTED. ADD'L: H020002/S5.
Description of Event or Problem · 1
IT WAS REPORTED IN 2007, A STENTING PROCEDURE OF THE ICA (INTERNAL CAROTID ARTERY). WHILE ADVANCING, THE STENT PREMATURELY DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS GOOD. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROFORM MICRODELIVERY STENT SYSTEM | NJE - STENT, INTRACRANIAL NEUROVASCULAR | NJE | NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION | SNF34520 | 9693966 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |