FDA Adverse Event
Injury
Summary report: N
AXIUM HELIX DETACHABLE COIL
MDR report key: 1060636
·
Received June 13, 2008
Report
- Report Number
- 2029214-2008-00110
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 15, 2008
- Report Date
- May 16, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT HAS BEEN RETURNED AND IS BEING EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. SEE SCANNED PAGE.
Description of Event or Problem · 1
COILING TREATMENT OF A RUPTURED ICA ANEURYSM. IT WAS REPORTED DURING COIL DELIVERY, RESISTANCE WAS ENCOUNTERED INSIDE THE CATHETER. THE PHYSICIAN CONTINUED TO ADVANCE THE COIL INTO THE ANEURYSM AND A LOOP OF THE COIL PROTRUDED THROUGH THE ANEURYSM WALL. THE PHYSICIAN ADVANCED THE COIL TO KEEP THE ANEURYSM WALL SEALED. THE PHYSICIAN TRIED TO DETACH THE COIL WITHOUT SUCCESS. THE COIL WAS WITHDRAWN AND AT THIS TIME, THE PT ICP INCREASED. THE PHYSICIAN WAS ABLE TO STOP THE BLEEDING BY PACKING THE ANEURYSM WITH ADD'L COILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM HELIX DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-3-6-HELIX | 5067278 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |