FDA Adverse Event
Malfunction
Summary report: N
MICRUS MICROCOIL SYSTEM
MDR report key: 1162288
·
Received September 5, 2008
Report
- Report Number
- 2954740-2008-00004
- Event Type
- Malfunction
- Date Received
- September 5, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 7, 2008
- Manufacturer
- MICRUS ENDOVASCULAR CORPORATION
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED FROM EVAL. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.
Description of Event or Problem · 1
AFTER THE COILING, NOTICED A DISSECTION IN THE CAROTID ARTERY AND ENDED UP STENTING THE CAROTID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRUS MICROCOIL SYSTEM | EMBOLIC COIL | HCG | MICRUS ENDOVASCULAR CORPORATION | NEUROPATH | F38475 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |