FDA Adverse Event
Injury
Summary report: N
GDC DETACHABLE COIL
MDR report key: 925927
·
Received October 9, 2007
Report
- Report Number
- 6000078-2007-00254
- Event Type
- Injury
- Date Received
- October 9, 2007
- Date of Event
- June 28, 2007
- Report Date
- September 10, 2007
- Manufacturer
- NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
- Product Code
- HCG
- PMA / PMN Number
- K991134
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
OTHER FOR NO MALFUNCTION OF THE DEVICE, BUT IT MAY HAVE CAUSED OR CONTRIBUTED TO THE THROMBUS. ADDITIONAL 510(K) # K001083. THE DEVICE REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
FOLLOWING THE SUCCESSFUL EMBOLIZATION OF THE ANEURYSM WITH THE COIL, A THROMBUS AT THE ANEURYSM NECK WAS OBSERVED. "THE THROMBUS PROTRUDED TO THE ARTERY LUMEN, CAUSING A 50% STENOSIS." THE THROMBUS WAS TREATED WITH REOPRO. THE PHYSICIAN STATED "THE PROCEDURE WAS SUCCESSFUL AND THERE WAS A GOOD EVOLUTION." THE PT WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC DETACHABLE COIL | (HCG) GDC COIL | HCG | NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION | 347509-SR | 9314021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |