FDA Adverse Event
Injury
Summary report: N
NEXUS MORPHEUS DETACHABLE COIL
MDR report key: 860411
·
Received June 5, 2007
Report
- Report Number
- 2029214-2007-00053
- Event Type
- Injury
- Date Received
- June 5, 2007
- Date of Event
- May 9, 2007
- Report Date
- May 9, 2007
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED WILL NOT BE RETURNED FOR EVAL AS IT WAS DISCARDED BY THE HOSP.
Description of Event or Problem · 1
TREATMENT OF A CAROTID OPHTHALMIC ANEURYSM THAT HAS BEEN COILED WITH 3 EA OF X-10-30-T10-MC, 3 EA OF X-9-28-T10-MC AND 1 EA OF X-8-25-T10-MC COIL, THE TIP OF ONE OF THE PREVIOUS IMPLANTED COILS HAD PROTRUDED INTO THE PARENT ARTERY. A MICRO SNARE WAS USED TO RETRIEVE THE COIL AND THE PROCEDURE WAS CONTINUED WITH ADD'L COILS. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXUS MORPHEUS DETACHABLE COIL | ELECTROLYTICALLY DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | X-6-20-T10-MC | 1884333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |