FDA Adverse Event
Malfunction
Summary report: N
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
MDR report key: 1032590
·
Received April 21, 2008
Report
- Report Number
- 1058196-2008-00103
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 2008
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- HDE H60001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. ADD'L INFO WILL NOT BE SUBMITTED WITHIN 30 DAYS.
Description of Event or Problem · 1
DURING AN EMBOLIZATION PROCEDURE TO TREAT A WIDE NECK ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY, THE 22MM ENTERPRISE STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE NECK OF THE ANEURYSM . THE VESSEL WAS NOT TORTUOUS, NOR WAS THERE ANY EXCESSIVE MANIPULATION OF THE MICROCATHETER OR DIFFICULTY PLACING THE STENT. THE PHYSICIAN WAS FOLLOWING DIRECTIONS AS PER (IFU) INSTRUCTION FOR USE AND UPON PLACING THE PROWLER SELECT PLUS DISTAL TO THE STENT IMPLANT SITE IN PREPARATION FOR THE MICROCATHETER EXCHANGE, THE STENT MIGRATED A FEW INCHES DISTAL. THE MIGRATION DID NOT COMPROMISE NECK COVERAGE OF THE ANEURYSM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PROWLER SELECT PLUS |