FDA Adverse Event
Malfunction
Summary report: N
CONCERTO NYLON HELICAL DETACHABLE COIL
MDR report key: 4202309
·
Received August 14, 2014
Report
- Report Number
- 2029214-2014-00489
- Event Type
- Malfunction
- Date Received
- August 14, 2014
- Date of Event
- July 18, 2014
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVAL.
Description of Event or Problem · 1
ON (B)(4) 2014, THE PT UNDERWENT COILING EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT PART OF THE IMPLANT COIL PREMATURELY DETACHED. THE PHYSICIAN WAS ABLE TO PULL THE PARTIALLY DETACHED IMPLANT COIL BACK INTO THE MICROCATHETER TO REMOVE IT FROM THE PT. THE ENTIRE SYSTEM WAS REMOVED FROM THE PT AND ACCESS WAS REGAINED THROUGH THE GASTRODUODENAL ARTERY. THE PT WAS REPORTED TO BE IN STABLE CONDITION. NO PT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487491 | CONCERTO NYLON HELICAL DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | NV-6-20-HELIX | 9912992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |