FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2113034
·
Received June 3, 2011
Report
- Report Number
- 2029214-2011-00126
- Event Type
- Injury
- Date Received
- June 3, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 4, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A LEFT PCA FUSIFORM ANEURYSM. IT WAS REPORTED AFTER THE PIPELINE WAS DEPLOYED, DURING ANGIOGRAPHY RUN, A SMALL DISSECTION OF THE P1 PROXIMAL TO THE ANEURYSM WAS NOTED. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | EMBOLIZATION DEVICE | HCG | EV3 NEUROVASCULAR | FA-77250-20 | 9387845 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |