FDA Adverse Event
Injury
Summary report: N
SOLITAIRE FR
MDR report key: 4233373
·
Received November 6, 2014
Report
- Report Number
- 2029214-2014-00635
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- September 1, 2014
- Report Date
- October 9, 2014
- Manufacturer
- COVIDIEN
- Product Code
- NRY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE (B)(4) STUDY. ON (B)(6) 2014, THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY. POST PROCEDURE, PUNCTATE HIGH DENSITY AREA WAS OBSERVED AT THE LEFT SYLVIAN FISSURE THROUGH XPERCT. ON DAY POST PROCEDURE, SLIGHT SAH (SUBARACHNOID HEMORRHAGE) WAS CONFIRMED THROUGH MRI T2 STAR. RELATIONSHIP TO THE SOLITAIRE DEVICE WAS UNKNOWN SINCE THE OTHER DEVICE (TREVO) WAS ALSO USED AND ACCESSED TO THE SAME AREA OF M2. THE PATIENT WAS REPORTED TO BE DOING FINE AND THE SAH WAS MINOR AND DID NOT GET ANY WORSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712984 | SOLITAIRE FR | FLOW RESTORATION | NRY | COVIDIEN | SFR-6-30 | 9894841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |