FDA Adverse Event
Death
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2878397
·
Received December 18, 2012
Report
- Report Number
- 2029214-2012-00718
- Event Type
- Death
- Date Received
- December 18, 2012
- Report Date
- November 22, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE EVENTS WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENTS.(B)(4).
Description of Event or Problem · 1
INFORMATION RECORDED FROM THE ARTICLE AJNR AM J NEURORADIAL 33:1436-46 PUBLISHED IN SEPTEMBER 2012. DURING A RETROSPECTIVE STUDY INVOLVING 251 ANEURYSMS TREATED WITH PEDS IN 191 CONSECUTIVE PATIENTS, ONE PATIENT DIED DUE TO A THROMBUS FORMATION, TWO PATIENTS DEVELOPED IPSILATERAL REMOTE INTRAPARENCHYMAL HEMATOMAS, ONE PATIENT HAD A SUBARACHNOID HEMORRHAGE, ONE PATIENT HAD DYSPHASIA, AND TWENTY-EIGHT PATIENTS WERE PRESENTED WITH A VISION ABNORMALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | VARIOUS | VARIOUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| S |