FDA Adverse Event
Malfunction
Summary report: N
AXIUM HELICAL DETACHABLE COIL
MDR report key: 2904182
·
Received January 9, 2013
Report
- Report Number
- 2029214-2013-00016
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 11, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).
Additional Manufacturer Narrative · 1
THE COIL WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND STRETCHED AND STUCK INSIDE THE INTRODUCER SHEATH. THERE WAS NO PREMATURE DETACHMENT OF THE IMPLANT COIL. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHEN PUSHING THE COIL IN THE MICROCATHETER. UPON WITHDRAWAL OF THE COIL INTO THE SHEATH, THE IMPLANT COIL WAS NOTICED TO BE MISSING. THE CATHETER WAS FLUSHED AND THERE WAS NO IMPLANT COIL TO BE FOUND NOR COULD IT BE VISUALIZED UNDER AN ANGIOGRAM. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11090 | AXIUM HELICAL DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-1.5-2-HELIX | 9642040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |