NEXUS MULTI-DIAMETER CSR AND NXT HELIX SOFT
Report
- Report Number
- 2029214-2008-00324
- Event Type
- Injury
- Date Received
- December 18, 2008
- Date of Event
- January 29, 2008
- Report Date
- November 18, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PT. MODELS AND LOT NUMBERS INVOLVED: MODEL#: X-12-23-T10-TC, LOT#: 2207171, DATE MANUFACTURE: 11/13/2006, EXPIRATION DATE: 11/01/2009. MODEL#: X-8-25-T10-MC, LOT#: 2239390, DATE MANUFACTURE: 11/30/2006, EXPIRATION DATE: 12/01/2009. MODEL#: N-4-10-T10-SO, LOT#: 4742598 (2EA), DATE MANUFACTURE: 12/15/2007, EXPIRATION DATE: 12/01/2010. MODEL#: X-7-15-T10-MC, LOT#: 2089649, DATE MANUFACTURE: 09/28/2006, EXPIRATION DATE: 10/01/2009. MODEL#: X-6-20-T10-MD, LOT#: 1740767 DATE MANUFACTURE: 04/14/2006, EXPIRATION DATE: 04/01/2009. MODEL#: X-6-20-T10-MD, LOT#: 1538916, DATE MANUFACTURE: 01/03/2006, EXPIRATION DATE: 01/01/2009. MODEL#: X-5-15-T10-MD, LOT#: 1740951, DATE MANUFACTURE: 04/14/2006, EXPIRATION DATE: 04/01/2009. MODEL#: NOT REPORTED, LOT#: 1715610, DATE MANUFACTURE, EXPIRATION DATE: REPORTED LOT NUMBER NOT EXISTED IN DATABASE.
TEN COILS WERE USED IN AN ANEURYSM COILING PROCEDURE. POST PROCEDURE, IT WAS REPORTED THE PHYSICIAN OBSERVED A METALLIC ARTIFACT NEAR THE ANEURYSM (FROM MRI IMAGES). NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXUS MULTI-DIAMETER CSR AND NXT HELIX SOFT | ELECTROLYTICALLY DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | X-10-20-T10-TC | 1492458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |