FDA Adverse Event
Injury
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 2071876
·
Received April 28, 2011
Report
- Report Number
- 2029214-2011-00087
- Event Type
- Injury
- Date Received
- April 28, 2011
- Date of Event
- March 25, 2011
- Report Date
- April 1, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. THE PUSHER ASSEMBLY WAS FOUND BROKEN AND THE RELEASE WIRE HAD BEEN PULLED BACK. THE IMPLANT LIKELY DETACHED WHEN THE PUSHER WAS BROKEN AND THE RELEASE WIRE WAS RETRACTED (THIS IS AN ALTERNATE METHOD OF DETACHMENT STATED IN THE IFU). (B)(4).
Description of Event or Problem · 1
COILING TREATMENT OF A MCA ANEURYSM. IT WAS REPORTED THE COIL COULD NOT BE DETACHED. UPON REMOVAL, THE COIL DETACHED INSIDE THE CATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE COIL INTO THE ANEURYSM WITH A GUIDEWIRE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-6-15-3D | 9251711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |