SolitaireTM SFR3-6-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536020559), received between Apr 9, 2019 and Jan 22, 2024 — classified as 2 deaths, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT AT 0:22, 2023-NOV-28, THE PATIENT SUDDENLY SUFFERED FROM UNSTABLE VITAL SIGNS, DEEP COMA, BILATERAL PUPIL ASYMMETRY, AND LOSS OF LIGHT REFLEX. DOCTOR'S EMERGENCY BEDSIDE TREATMENT. ON (B)(6) 2023 THE PATIENT WAS IN A DEEP COMA AND BREATHING WAS ASSISTED BY AN INVASIVE VENTILATOR. THE PATIENT WAS GENERALLY GIVEN HYPOTHERMIA BRAIN PROTECTION TREATMENT. AT 17:14 ON (B)(6) 2023 THE PATIENT'S BLOOD PRESSURE DROPPED ABOUT 71/40MMHG. 20:32 THE PATIENT'S HEART STOPPED, THE MAJOR ARTERY BEAT DISAPPEARED, THE ELECTROCARDIOGRAM SHOWED A STRAIGHT LINE, AND THE PATIENT DIED. THIS EVENT WAS NOT A RECURRENT OR NEW STROKE AND WAS NOT RELATED TO THE DISEASE UNDER STUDY  OR AN UNDERLYING CONDITION OR DISEASE. THIS EVENT DID NOT RESULT FROM A DEVICE DEFICIENCY. MODIFIED RANKIN SCALE (MRS) SCORE 0, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE 11. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE. PRE-PROCEDURE MTICI SCORE 0, FINAL POST-PROCEDURE MTICI SCORE 3.

  Patient problems: Coma; Hemorrhagic Stroke; Low Blood Pressure/ Hypotension; Paraplegia; Thrombosis/Thrombus; Ventilator Dependent

  MAUDE report 18556378 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD UNDERGONE A THROMBECTOMY PROCEDURE WITH A SOLITAIRE PLATINUM STENT RETRIEVER. THERE WAS NOT NOTED DEVICE DEFICIENCY OR INTRA-OPERATIVE ISSUE. POST-OPERATIVELY, IT WAS NOTED THAT THE PATIENT HAD A FEMORAL ACCESS VESSEL PSEUDOANEURYSM DUE TO THE TEAR IN THE POSTERIOR WALL OF THE RIGHT FEMORAL ARTERY WHICH WAS FOUND WITH ULTRASOUND ON (B)(6) 2022. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY AND THE EVENT WAS NOTED TO BE RESOLVED ON (B)(6) 2022. THE STUDY SPONSOR ASSESSMENT NOTED THE EVENT TO BE CONSIDERED SERIOUS. THE EVENT WAS NOT RELATED TO THE SOLITAIRE DEVICE BUT HAD A CAUSAL RELATIONSHIP TO THE PROCEDURE.

  Patient problems: Pseudoaneurysm

  MAUDE report 15138311 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS AN OPENING UP OF LARGE VESSELS INCLUDING THE LEFT ICA AND MCA REPERFUSION CAUSED AND RESULTED IN AN REPERFUSION INJURY BUT WITHOUT ANY SIGNIFICANT WORSENING. THERE WAS A CT SCAN TAKEN OF THE BRAIN, WHICH SHOWED PH2 HEMORRHAGIC TRANSFORMATION OF THE LEFT MCA INFARCT OF 6ML VOLUME. THIS WAS CONSIDERED CLINICALLY SIGNIFICANT. THE AVERSE EVENT WAS CASUALLY RELATED TO THE STUDY PROCEDURE AND THE DISEASE UNDER STUDY. THE ADVERSE EVENT WAS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE OTHER THAN THE DISEASE UNDER STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14458492 ↗
• DeathDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT DIED DUE TO CEREBRAL HEMORRHAGE DURING A SOLITAIRE PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT FOR ISCHEMIC CEREBRAL INFARCTION IN THE INTERNAL CAROTID ARTERY. TWO PASSES HAD BEEN MADE WITH THE SOLITAIRE DEVICE. THE PATIENT'S VESSEL TORTUOSITY WAS STRONG. IT WAS REPORTED THAT PATIENT DEVELOPED CEREBRAL INFARCTION ASSOCIATED WITH OCCLUSION FROM THE INTERNAL CAROTID ARTERY TO THE MIDDLE CEREBRAL ARTERY (M1, M2) AND WAS TRANSPORTED TO THE HOSPITAL. A SOLITAIRE REVASCULARIZATION DEVICE WAS DEPLOYED TWICE IN THE C2 OCC LUSION SITE OF THE INTERNAL CAROTID ARTERY. SUBSEQUENTLY, AN EMBOTRAP REVASCULARIZATION DEVICE WAS DEPLOYED TWICE IN THE INTERNAL CAROTID ARTERY TERMINAL OCCLUSION SITE, AND WAS DEPLOYED TWICE IN THE MIDDLE CEREBRAL ARTERY BRANCH OCCLUSION SITE. IT WAS STUCK ON THE DISTAL SIDE WHEN THE LAST THROMBUS WAS COLLECTED. WHEN THE CATHETER WAS WITHDRAWN AS IS, STRAIGHTENING OF THE BLOOD VESSEL WAS OBSERVED FROM THE MIDDLE CEREBRAL ARTERY M1 TO THE M2 REGION, AND WHEN THE CATHETER WAS WITHDRAWN CONTINUOUSLY, THE STUCK WAS COME OFF. SUBSEQUENTLY, HEMORRHAGING OCCURRED. TREATMENT FOR HEMORRHAGING IS UNKNOWN. THE FINAL REVASCULARIZATIO

  Patient problems: Intracranial Hemorrhage

  MAUDE report 13005443 ↗
• MalfunctionSep 1, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT, UPON REMOVAL OF THE SOLITAIRE AFTER RETRIEVAL, IT WAS RECOGNIZED THAT THE TIP OF THE STENT WAS NO LONGER CONNECTED. FLUOROSCOPY SHOWED THE TIP WAS RETAINED IN THE RIGHT MCA, PREVENTING RECANALIZATION. THE DETACHED PORTION WAS ABLE TO BE RETRIEVED. THE PATIENT WAS UNDERGOING THROMBECTOMY OF A RIGHT-SIDED MIDDLE CEREBRAL ARTERY STROKE WITH COMPLETE OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY AND M1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10476634 ↗
• MalfunctionJul 20, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE FR SEPARATED WITHIN THE LUMEN OF THE REACT 71 CATHETER. IT WAS REPORTED THAT DURING THROMBUS COLLECTION, THE SOLITAIRE EXPERIENCED RESISTANCE NEAR THE MIDDLE OF THE CATHETER. IT WAS PULLED STRONGLY, AND THE JOINT PORTION OF THE SOLITAIRE AND THE PUSHWIRE DETACHED. THE STENT PORTION WAS WITHIN THE CATHETER AND WAS RETRIEVED AND REMOVED FROM THE BODY WITH THE CATHETER. THE PROXIMAL MARKER ON THE STENT HAD BEEN INSIDE THE MICROCATHETER. TWO PASSES HAD BEEN MADE WITH THE STENT. THE DOCTOR DID NOT TORQUE THE DELIVERY PUSHER. NO SYMPTOMS OR COMPLICATIONS WERE RELATED TO THIS EVENT. AFTER THROMBUS COLLECTION, A CAROTID ARTERY STENT WAS IMPLANTED IN THE STENOSIS SITE. AT THAT TIME, THE GUIDING WAS ADVANCED TOO MUCH, AND A CAROTID-CAVERNOUS SINUS FISTULA (CCF) WAS CAUSED AND THE PATIENT DIED. IT HAD BEEN CONFIRMED THAT THE PHYSICIAN ADMITTED THIS WAS A PROCEDURAL MISTAKE. WHEN THE CCF WAS CAUSED, THE MEDTRONIC DEVICE WAS NOT IN USE. IT WAS STATED THAT THERE WAS NO RELATIONSHIP BETWEEN THE PATIENT¿S DEATH AND THE MEDTRONIC DEVICE. TISSUE PLASMINOGEN ACTIVATOR HAD BEEN ADMINISTERED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10295091 ↗
• MalfunctionJun 17, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT UPON THE FIRST RETRIEVAL OF THE SOLITAIRE PLATINUM, IT UNINTENTIONALLY SEPARATED. THE SFR3 WAS ENGAGED IN THE CLOT AND PARTIALLY INSIDE OF MEDTRONIC CATHETER WHEN IT MET RESISTANCE. THE PHYSICIAN PULLED A BIT MORE WHEN THE SFR3 FRACTURED INSIDE OF THE REACT. EVERYTHING WAS REMOVED FROM THE PATIENT. THE PATIENT DID NOT HAVE VESSEL STENOSIS PROXIMAL TO THE THROMBUS SITE. THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE. THE MICROCATHETER TIP DID NOT COVER THE STENT¿S PROXIMAL MARKER DURING THE RETRIEVAL. NO PATIENT INJURY WAS REPORTED. THE POST INTERVENTION TICI WAS REPORTED TO HAVE BEEN 3. THE VESSEL ANATOMY WAS REPORTED TO HAVE BEEN MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8703693 ↗
• InjuryApr 9, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE SOLITAIRE PLATINUM WAS RETRIEVED THROUGH THE CAROTID STENT, WHEN IT BECAME CAUGHT IN STENT AND BROKE OFF. ALL WIRES AND CATHETERS WERE REMOVED FROM THE PATIENT. THE STENT WAS LEFT BEHIND. THERE WERE NO REPORTS OF PATIENT SYMPTOMS POST-PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8498144 ↗