SOLITAIRE FR
Report
- Report Number
- 2029214-2026-00601
- Event Type
- Malfunction
- Date Received
- April 3, 2026
- Date of Event
- March 24, 2026
- Report Date
- May 6, 2026
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- NRY
- UDI-DI
- 00763000927363
- PMA / PMN Number
- K113455
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B5: ADDITIONAL INFORMATION SHOULD'VE BEEN A PART OF THE INITIAL REPORT. CORRECTION SENT TO INCLUDE THIS INFORMATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT FOR SOLITAIRE FR (LOT NO. D054625) IT WAS CLARIFIED THAT "FAILED TO RETRIEVE CLOT" WAS IN REFERENCE TO, "AFTER MULTIPLE ATTEMPTS, THE EMBOLUS COULD NOT BE REMOVED, AND IT WAS SUCCESSFULLY REMOVED AFTER REPLACEMENT." THERE WERE NO CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO RETRIEVE IDENTIFIED. FOR THE SOLITAIRE FR (LOT NO. D060303) THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE PACKAGE WAS NOT DAMAGE ON DELIVERY IT WAS NOTED TO BE INTACT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT, "THE PATIENT¿S POST-THROMBECTOMY CONDITION WAS THROMBUS REMOVAL WAS SUCCESSFULLY COMPLETED AFTER REPLACEMENT; THE PATIENT IS IN GOOD CONDITION."
MEDTRONIC RECEIVED A REPORT OF ONE SOLITAIRE FR THAT WAS NOT RECEIVED AND ANOTHER SOLITAIRE FR THAT FAILED TO RETRIEVE THE PATIENTS CLOT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ACUTE CEREBRAL INFARCTION. THE STROKE ONSET TO REPERFUSION TIME WAS 6. IT WAS REPORTED THAT ONE SOLITAIRE FR LOT NO. D060303: THE OUTER PACKAGING WAS INTACT AND THE INNER PACKAGING WAS ALSO INTACT, BUT AFTER OPENING, THE PHYSICIAN FOUND THAT THERE WAS NO PRODUCT IN THE PLASTIC TRAY. ANOTHER SOLITAIRE FR LOT NO. D054625: MULTIPLE THROMBECTOMY ATTEMPTS WITH THIS PRODUCT FAILED TO RETRIEVE THE CLOT. AFTER REPLACING IT WITH A NEW DEVICE, THE CLOT WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270457 | SOLITAIRE FR | CATHETER, THROMBUS RETRIEVER | NRY | MICRO THERAPEUTICS, INC. DBA EV3 | SFR-6-30 | D054625 | 00763000927363 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |