FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3041519
·
Received April 8, 2013
Report
- Report Number
- 2029214-2013-00341
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- 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 UNRUPTURED CAV (CAVERNOUS) SACCULAR ANEURYSM MEASURING 16MM X 10MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PHYSICIAN HAD A DIFFICULT TIME RELEASING THE PIPELINE FROM THE CAPTURE COIL. AFTER SOME MANIPULATION, THE PIPELINE WAS RELEASED FROM THE CAPTURE COIL AND IMPLANTED IN THE PATIENT. NO INJURY AS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143187 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77475-20 | 9602504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Disability |