SOLITAIRE FR
Report
- Report Number
- 2029214-2025-02548
- Event Type
- Malfunction
- Date Received
- December 5, 2025
- Date of Event
- December 3, 2025
- Report Date
- February 3, 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
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
H3 PRODUCT ANALYSIS: ¿ AS FOUND CONDITION: THE SOLITAIRE FR DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, A PLASTIC POUCH, AND ITS ORIGINAL INNER POUCH. ¿ DAMAGE LOCATION DETAILS: THE SOLITAIRE FR DEVICE WAS RETURNED WITHIN ITS INTRODUCER SHEATH. NO DAMAGE WAS FOUND WITH THE INTRODUCER SHEATH. THE STENT¿S PUSHWIRE WAS FOUND DAMAGED (BENT) ~11.5 CM FROM THE DISTAL END. THE MARKER COIL WAS FOUND BENT AT MULTIPLE LOCATIONS. THE STENT¿S NON-WORKING LENGTH TEAR DROP STRUT WAS FOUND BENT. THE STENT¿S WORKING LENGTH STRUTS WERE FOUND TO BE IN GOOD CONDITION. ¿ TESTING/ANALYSIS: THE SOLITAIRE FR DEVICE WAS PUSHED OUT FROM WITHIN ITS INTRODUCER SHEATH WITHOUT RESISTANCE. THE SOLITAIRE FR DEVICE COULD NOT BE USED FOR RESISTANCE TESTING WITH AN IN-HOUSE CATHETER DUE TO ITS DAMAGED CONDITION. ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿RESISTANCE DURING DELIVERY¿ REPORT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES PUSHING THE DEVICE OUT FROM WITHIN ITS INTRODUCER SHEATH. IN ADDITION, THE DEVICE COULD NOT BE USED FOR RESISTANCE TESTING. HOWEVER, THE CUSTOMER¿S ¿KINK/DAMAGE¿ REPORT WAS CONFIRMED AS THE RETURNED SOLITAIRE FR DEVICE WAS FOUND DAMAGED (BENT) AT THE PUSHWIRE ~11.5 CM FROM THE DISTAL END, THE STENT¿S MARKER COIL WAS FOUND BENT AT MULTIPLE LOCATIONS, AND THE STENT¿S NON-WORKING LENGTH TEAR DROP STRUT WAS FOUND BENT. DAMAGE CAN OCCUR IF THE DEVICE IS ADVANCED AGAINST RESISTANCE. HOWEVER, THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. POTENTIAL CONTRIBUTORS TO ¿RESISTANCE¿ INCLUDE USE OF AN INCOMPATIBLE CATHETER, CATHETER DAMAGE, PATIENT VESSEL TORTUOSITY, OR NOT MAINTAINING A CONTINUOUS SALINE FLUSH. A CONTINUOUS FLUSH WAS MAINTAINED, RULING OUT ¿NOT MAINTAINING A CONTINUOUS FLUSH¿ AS A POTENTIAL CAUSE. THE CATHETER INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, CATHETER-RELATED CONTRIBUTION (I.E., CATHETER DAMAGE/COMPATIBILITY) COULD NOT BE EVALUATED. IT IS POSSIBLE THAT THE PATIENT¿S ¿MODERATE¿ VESSEL TORTUOSITY CONTRIBUTED TO THE REPORTED RESISTANCE. HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE SPECIFIC CAUSE OF THE REPORTED RESISTANCE COULD NOT BE DETERMINED. 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 SUBSEQUENT TO THROMBUS ASPIRATION PROCEDURES, A NON-MEDTRONIC GUIDEWIRE AND STENT CATHETER WERE POSITIONED INTO THE RIGHT M3 SEGMENT. ¿SMOKE¿ IMAGING REVEALED THROMBUS IN THE RIGHT M2 SEGMENT, AS WELL AS IN THE RIGHT C6¿C7 SEGMENTS. THE STENT CATHETER WAS INSERTED INTO THE NON-MEDTRONIC INFUSION CATHETER AND POSITIONED AT THE DISTAL M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. ANGIOGRAPHY THROUGH THE CATHETER SHOWED GOOD VISUALIZATION OF THE DISTAL VESSELS. THE SOLITAIRE FR (SFR-6-30) INTRACRANIAL THROMBECTOMY STENT (LOT NO.: D035328) WAS FULLY HYDRATED AND INTENDED TO BE DELIVERED TO THE LESION SITE VIA THE INFUSION CATHETER. THE STENT INTRODUCER AND THE PROXIMAL END OF THE INFUSION CATHETER WERE PROPERLY CONNECTED, BUT THE STENT COULD NOT BE ADVANCED INTO THE INFUSION CATHETER DESPITE MULTIPLE ATTEMPTS. AFTER REMOVING THE INFUSION CATHETER AND CONFIRMING THAT THERE WERE NO ISSUES WITH THE PRODUCT, THE INFUSION CATHETER WAS RE-INSERTED; HOWEVER, THE STENT HAD ALREADY BECOME DEFORMED AT THE STENT CONNECTION POINT. TO ENSURE THE SMOOTH PROGRESS OF THE SURGERY, AN SFR-4-20 INTRACRANIAL THROMBECTOMY STENT (LOT NO.: D032937) WAS IMMEDIATELY REP LACED AND PREPARED ACCORDING TO THE STANDARD HYDRATION PROCEDURE. THE THROMBECTOMY STENT WAS SUCCESSFULLY DELIVERED TO THE DISTAL END OF THE STENT CATHETER. THE STENT CATHETER WAS SLOWLY WITHDRAWN, AND AFTER WAITING FOR 5 MINUTES, THE STENT WAS RETRIEVED WHILE CONTINUOUS ASPIRATION WAS PERFORMED THROUGH THE INTERMEDIATE CATHETER. UPON REMOVAL, A SMALLAMOUNT OF THROMBUS WAS OBSERVED ON THE STENT AND INSIDE THE ASPIRATION CATHETER. ANGIOGRAPHY SHOWED PATENCY OF THE RIGHT INTERNAL CAROTID ARTERY, BUT OCCLUSION OF THE RIGHT M2 SEGMENT. THE SAME STENT THROMBECTOMY PROCEDURE WAS PERFORMED TWICE MORE FOR THE M2 THROMBUS, BUT RECANALIZATION WAS NOT ACHIEVED. CONSIDERING THAT THE PATIENT HAD RECEIVED ALTEPLASE THROMBOLYSIS BEFORE SURGERY, FURTHER STENT THROMBECTOMY WOULD INCREASE THE RISK OF BLEEDING. THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS UNDERGOING A THROMBECTOMY SURGERY FOR TREATMENT OF A ISCHEMIC STROKE IN THE RIGHT M2. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE AND THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERTENSION. THE PATIENT'S BASELINE MODIFIED RANKIN SCORE (MRS) WAS 4 AND WAS 4 POST-PROCEDURE. THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE REMAINED THE SAME WITH BASELINE SCORE OF 14 TO 14 POST-PROCEDURE. THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE IMPROVED FROM 1 AT BASELINE TO 2B POST-PROCEDURE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED IN THIS CASE. THE PROCEDURE INVOLVED TWO PASSES WITH THE DEVICE. THE STROKE ONSET TO REPERFUSION TIME WAS 6.5 HOURS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED: FATHOM-14 MICRO GUIDEWIRE, PROWLER PLUS STENT CATHETER, 606S255X INFUSION CATHETER. THE FOLLOWING HAS BEEN RULED OUT AS A NON-COMPLAINT: THE REPORTED OCCLUSION OF THE RIGHT M2 SEGMENT, RECANALIZATION NOT ACHIEVED, AND PATIENT POST TREATMENT CONDITION WERE PREEXISTING, AND DID NOT WORSEN DUE TO TREATMENT WITH THE DEVICE THEREFORE THEY ARE NOT CONSIDERED AS A SERIOUS INJURY. THIS DOES NOT MEET THE DEFINITION OF A COMPLAINT. THERE WERE NO SAFETY, PACKAGING, LABELING, IDENTITY, QUALITY, RELIABILITY, DURABILITY, EFFECTIVENESS, PERFORMANCE ISSUE, OR ADVERSE EVENT ALLEGED AGAINST THE REPLACEMENT SFR DEVICE; RULED OUT PER 027-WI185.
ADDITIONAL INFORMATION WAS RECEIVED THAT RESISTANCE OCCURRED IN THE DISTAL SECTION OF THE CATHETER. THE CATHETER FLUSH WAS ADMINISTERED PER IFU DURING THE PROCEDURE. THERE WAS NO KINK OR DAMAGE TO THE CATHETER OR PUSHWIRE OF THE SOLITAIRE. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER. THE CAUSE OF THE RESISTANCE AND DEVICE DAMAGE WAS NOT DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2043503 | SOLITAIRE FR | CATHETER, THROMBUS RETRIEVER | NRY | MICRO THERAPEUTICS, INC. DBA EV3 | SFR-6-30 | D035328 | 00763000927363 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female |