FDA Adverse Event
Injury
Summary report: N
SOLITAIRE FR
MDR report key: 2840741
·
Received November 20, 2012
Report
- Report Number
- 2029214-2012-00658
- Event Type
- Injury
- Date Received
- November 20, 2012
- Date of Event
- October 24, 2012
- Report Date
- October 24, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- NRY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION AND THE STENT WAS FOUND DETACHED.(B)(4).
Description of Event or Problem · 1
THROMBECTOMY IN THE M1. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN USED THE 4X20 SOLITAIRE WITH AN ORION CATHETER AND WAS ABLE TO RESTORE BLOOD FLOW, BUT WAS NOT ABLE TO REMOVE THE CLOT. THE PHYSICIAN CHANGED OUT THE ORION FOR A MARKSMAN AND 6X30 SOLITAIRE AND GOT FLOW RESTORATION WITH THE FIRST PAST BUT WAS NOT ABLE TO REMOVE THE CLOT. ON THE SECOND PASS, MORE FLOW WAS RESTORED, BUT THE SOLITAIRE WAS STUCK. THE PHYSICIAN NOTED THAT HE THEN PULLED HARDER THAN NORMAL AND THE STENT DETACHED AND REMAINED IN THE PATIENT. IT WAS REPORTED THE PATIENT HAD NEUROLOGICAL COMPLICATIONS, BUT THEY IMPROVED AS OF (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLITAIRE FR | FLOW RESTORATION | NRY | EV3 NEUROVASCULAR | SFR-6-30 | 9597290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Disability |