FDA Adverse Event
Injury
Summary report: N
PALMAZ GENESIS OPTA PRO
MDR report key: 1080184
·
Received July 21, 2008
Report
- Report Number
- 9610978-2008-00186
- Event Type
- Injury
- Date Received
- July 21, 2008
- Date of Event
- June 19, 2008
- Report Date
- June 24, 2008
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- FGE
- PMA / PMN Number
- K012590
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
THE PHYSICIAN PLACED THE STENT IN THE SUBCLAVIAN ARTERY, ON THE SAME NIGHT AS THE PROCEDURE, THE VESSEL BECAME TOTALLY OCCLUDED. THE PATIENT WAS SENT FOR AN EMERGENCY BYPASS SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALMAZ GENESIS OPTA PRO | ENDOVASCULAR SDS/STENTS (FGE) | FGE | CORDIS EUROPA, N.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| L| R |