FDA Adverse Event
Injury
Summary report: N
MICROPLEX 10-SYSTEM DETACHABLE COIL (MCS)
MDR report key: 2161989
·
Received May 18, 2011
Report
- Report Number
- 2032493-2011-00011
- Event Type
- Injury
- Date Received
- May 18, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- MICROVENTION, INC.
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SAMPLE ANALYSIS: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE DEPLOYMENT OF AN EMBOLIZATION COIL, THE COIL DID NOT DETACH. UPON WITHDRAW, THE COIL DETACHED PARTIALLY WITHIN THE MICROCATHETER AND THE ANEURYSM. A STENT WAS PLACED TO TACK THE COIL IN PLACE. THE PATIENT WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE. NO HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROPLEX 10-SYSTEM DETACHABLE COIL (MCS) | EMBOLIZATION COIL | HCG | MICROVENTION, INC. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |