FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2821492
·
Received November 6, 2012
Report
- Report Number
- 2029214-2012-00591
- Event Type
- Injury
- Date Received
- November 6, 2012
- Date of Event
- August 4, 2011
- Report Date
- October 7, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
UPDATED THE MODEL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT.(B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS IMPLANTED IN THE PATIENT.(B)(4).
Description of Event or Problem · 1
INFORMATION FROM (B)(6) CLINICAL DATABASE.POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS EXTUBATED AND EXPERIENCED A LEFT SIDED WEAKNESS. THE PATIENT WAS THEN RE-INTUBATED AND HAD ANOTHER ANGIO PERFORMED SHOWING A SLOW FLOW DUE TO A LEFT POSTERIOR INTERNAL CAROTID ARTERY (PICA) THROMBUS FORMATION. BOLUS OF ABCIXIMAB MARKED IMPROVEMENT OF BLOOD FLOW.THE ISSUES SUBSEQUENTLY RESOLVED AND NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | EMBOLIZATION DEVICE | OUT | EV3 NEUROVASCULAR | FA-77475-20 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Unknown | Disability |