SOLITAIRE FR
Report
- Report Number
- 2029214-2025-01380
- Event Type
- Malfunction
- Date Received
- June 16, 2025
- Date of Event
- June 10, 2025
- Report Date
- August 28, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- NRY
- UDI-DI
- 00847536018556
- PMA / PMN Number
- K113455
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: UNK-NV-REBAR (UNKNOWN); IMPLANT DATE: N/A; EXPLANT DATE: N/A. 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: PRODUCT ANALYSIS AS FOUND CONDITION: THE SOLITAIRE FR 6-30 STENT DEVICE WAS RETURNED FOR ANALYSIS, STILL INSIDE ITS INTRODUCER SHEATH, A DISPENSER COIL, IN A POUCH, WITHIN A BIOHAZARD BAG, AND A SHIPPING BOX. THE REPORTED REBAR 18 CATHETER WAS NOT RETURNED WITH THE SOLITAIRE STENT DEVICE. DAMAGED LOCATION DETAILS: THE SOLITAIRE FR 6-30 STENT¿S FINGER MARKERS WERE EXAMINED INSIDE THE INTRODUCER SHEATH. ALL FINGER MARKERS WERE ALIGNED CORRECTLY, AND NO DAMAGE WAS OBSERVED. THE INTRODUCER SHEATH WAS IN GOOD CONDITION. THE STENT¿S WORKING AND NON-WORKING LENGTH STRUTS WERE IN GOOD CONDITION. NO IRREGULARITIES WERE OBSERVED OUTSIDE THE PROXIMAL MARKER. THE MARKER COIL WAS BENT AT ~5.0CM TO ~7.0CM FROM THE DISTAL TIP. THE PUSHER WIRE WAS OBSERVED TO BE KINKED AT ~16.0CM FROM THE DISTAL TIP. NO OTHER ANOMALIES WERE FOUND. TESTING/ANALYSIS: DUE TO ITS DAMAGED CONDITION, THE RETURNED SOLITAIRE FR 6-30 STENT DEVICE COULD NOT BE USED FOR RESISTANCE TESTING. CONCLUSION: BASED ON THE REPORTED INFORMATION AND DEVICE ANALYSIS, THE CUSTOMER¿S ¿RESISTANCE DURING DELIVERY/RETRIEVAL¿ COMPLAINT WAS CONFIRMED, AS THE MARKER COIL AND PUSHER WIRE ON THE RETURNED SOLITAIRE FR 6-30 STENT DEVICE WERE DAMAGED (BENT AND KINKED). THE DAMAGES LIKELY OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE THE SOLITAIRE FR 6-30 STENT DEVICE THROUGH THE REPORTED REBAR 18 CATHETER AGAINST RESISTANCE. IN THIS EVENT, THE ROOT CAUSE OF THE RESISTANCE COMPLAINT WAS THAT THE REBAR 18 CATHETER WAS INCOMPATIBLE WITH THE SOLITAIRE FR 6-30 STENT DEVICE, AS IT HAS A LABELED INSIDE DIAMETER (ID) OF 0.021 INCHES. PER THE SOLITAIRE FR INSTRUCTIONS FOR USE (IFU): ¿SOLITAIRE FR 6-30 SHOULD BE DELIVERED THROUGH A CATHETER WITH A MINIMUM INSIDE DIAMETER (ID) OF 0.027 INCHES.¿ 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.
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.
MEDTRONIC RECEIVED A REPORT THAT DURING THE DELIVERY, THE SOLITAIRE SFR STENT ENCOUNTERED RESISTANCE AT THE REBAR CATHETER IN DISTAL SECTION. THE PATIENT WAS UNDERGOING TREATMENT FOR THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 100 MINUTES. THE VESSEL WAS NOT TORTUOUS IT WAS REPORTED THAT WHILE USING THE REBAR18 MICROCATHETER TO DELIVER THE SFR-6-30 THROMBECTOMY STENT, THE STENT COULD NOT BE ADVANCED TO THE DISTAL END. THE SURGEON REPORTED SIGNIFICANT RESISTANCE. AFTER WITHDRAWING THE STENT AND ATTEMPTING DELIVERY AGAIN, IT STILL COULD NOT BE ADVANCED. THE SURGEON REPLACED IT WITH ANOTHER SFR STENT, WHICH SUCCESSFULLY PASSED THROUGH. THE SURGEON DECIDED NOT TO CHARGE FOR THE INITIAL STENT AND REQUESTED A COMPLAINT TO BE FILED FOR THE ISSUE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S BASELINE NIHSS 24. POST-THROMBECTOMY CONDITION NIHSS 6. CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE OBSERVED TO THE REBAR18 AND STENT AFTER REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1683518 | SOLITAIRE FR | CATHETER, THROMBUS RETRIEVER | NRY | MICRO THERAPEUTICS, INC. DBA EV3 | SFR-6-30 | B799650 | 00847536018556 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | SEE H11... |