FDA Adverse Event
Injury
Summary report: N
NEUROPFORM3 MICRODELIVERY STENT SYSTEM
MDR report key: 1050228
·
Received May 22, 2008
Report
- Report Number
- 2939204-2008-00201
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- April 26, 2008
- Report Date
- April 26, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- NJE
- PMA / PMN Number
- H020002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A STENT ASSISTED COILING EMBOLIZATION PROCEDURE WAS PERFORMED IN THE C4 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY ( ICA). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DELIVERING THE SUBJECT DEVICE DUE TO THE CURVATURE OF THE LESION AND THE PT'S TORTUOUS ANATOMY. THE SUBJECT DEVICE WAS RELEASED EARLY IN THE RIGHT C3 BUT WAS REPORTEDLY UNSUCCESSFUL. THE STENT WAS LEFT IMPLANTED. THE PHYSICIAN USED ANOTHER STENT TO COVER THE NECK OF THE ANEURYSM AND FINISHED THE COILING PROCEDURE SUCCESSFULLY. CURRENTLY, THE PT'S CONDITION IS REPORTED AS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROPFORM3 MICRODELIVERY STENT SYSTEM | INTERCRANIAL STENT (NJE) | NJE | BOSTON SCIENTIFIC CORP. | E340015 | 9548180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |