FDA Adverse Event
Injury
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 2180342
·
Received July 27, 2011
Report
- Report Number
- 2029214-2011-00192
- Event Type
- Injury
- Date Received
- July 27, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. THE TACK WELD ON THE PUSHER ASSEMBLY WAS FOUND BROKEN. THE BROKEN TACK WELD LIKELY CAUSED THE COIL TO DETACH. (B)(4)
Description of Event or Problem · 1
COILING TREATMENT OF AN ANEURYSM. IT WAS REPORTED THE COIL PREMATURELY DETACHED DURING COIL REPOSITIONING. APPROXIMATELY 2 LOOPS OF THE COIL WAS OBSERVED PROTRUDING INTO THE PARENT ARTERY. AS A PRECAUTION, THE PATIENT WAS PLACED ON HEPARIN AND ASPIRIN. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-2-6-3D | 9432852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |