FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2821496
·
Received November 6, 2012
Report
- Report Number
- 2029214-2012-00592
- Event Type
- Injury
- Date Received
- November 6, 2012
- Date of Event
- September 6, 2011
- Report Date
- October 7, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RECEIVED INFORMATION ON OTHER DEVICE INVOLVED IN THE EVENT AS FOLLOWS:MODEL#: FA-77375-14 / LOT#: NOT REPORTED / DOM: N/A / EXP: NA.(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).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INFORMATION FROM (B)(6) CLINICAL DATABASE. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT COMPLAINED OF A SEVERE HEADACHE ON THE LEFT SIDE IN THE OPHTHALMIC (V1) AND INNERVATIONS ARE IN LEFT TRIGEMINAL NERVE. SHE STATES THAT THE HEADACHES ARE CONSTANT AND DISABLING. THESE ISSUES SUBSEQUENTLY RESOLVED AND NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | EMBOLIZATION DEVICE | OUT | EV3 NEUROVASCULAR | FA-77375-20 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Disability |