SolitaireTM SFR3-4-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536020535), received between Mar 15, 2017 and Jan 12, 2024 — classified as 1 death, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS INCREASED HEMORRHAGE IN THE RIGHT BASAL GANGLIA REGION WITH A NIHSS SCORE OF 4. THE PATIENT HAD AN INDICATION FOR ANTICOAGULATION. ZHONGTIAN ASPIRATION CATHETER WAS USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia

  MAUDE report 18503981 ↗
• InjuryAug 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE WHEN A CONE-BEAM CT IMAGE WAS TAKEN AFTER THE REMOVAL OF THE THROMBUS, IT WAS NOTICED THAT THERE WAS SOMETHING SHINING. IT WAS POSSIBLE THIS WAS THE MARKER FROM THE REACT 71 OR PHENOM CATHETERS OR THE SOLITAIRE STENT RETRIEVER. TWO PASSES HAD BEEN MADE WITH THE SOLITAIRE. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY FOR AN INFARCTION IN THE MIDDLE CEREBRAL ARTERY. THE PATIENT'S TICI SCORE AFTER SURGERY WAS 2C. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS PERFORMED. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE MIDDLE CEREBRAL ARTERY, WHICH WAS 2.5MM IN DIAMETER. ANCILLARY DEVICES INCLUDE A TRAK 21 CATHETER AND A TREVO 3 -32 STENT RETRIEVER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12359300 ↗
• MalfunctionDec 23, 2020No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT A FOREIGN MATERIAL WAS OBSERVED IN ANGIOGRAPHY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC CEREBRAL INFARCTION OF THE RIGHT M1. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE, TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT PERFORMED, AND TIME TO RECANALIZATION WAS ABOUT 1.5 HOURS. IT WAS REPORTED THAT THE M1 THROMBUS WAS RETRIEVED BY THE COMBINED TECHNIQUE WITH THE REACT CATHETER AND SOLITAIRE. THE THROMBUS WAS CAPTURED AND RETRIEVED WITH THE SOLITAIRE. AFTERWARDS, ANGIOGRAPHY SHOWED SOMETHING LIKE A FOREIGN MATERIAL AROUND THE M2 OR M3 REGION. IT WAS UNKNOWN WHETHER IT WAS DUE TO THE RETENTION OF CONTRAST AGENT OR PART OF THE DEVICE. COMPARING THE RETRIEVED DEVICES WITH THE DEMO PRODUCTS, THERE WERE NO ABNORMALITIES IN THE APPEARANCE OF THE SOLITAIRE, REACT 71, OR PHENOM 27. THE FOREIGN MATERIAL WAS NOT RETRIEVED AND REMAINED WITHOUT ANY ACTIONS. A REQUEST FOR INSPECTION RESULTS TO CONFIRM WHETHER THE FOREIGN MATERIAL WAS PART OF THE DEVICE BY DOMESTIC MICROSCOPY. ANCILLARY DEVICES INCLUDE A 9F OPTIMO, PHENOM 27, CHIKAI GUIDEWIRE, REACT 71 CATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT EXPERIENCE

  Patient problems: Foreign Body In Patient

  MAUDE report 11062070 ↗
• InjuryApr 30, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE STENT AND MARKSMAN CATHETER USED DURING A PROCEDURE IN WHICH A FRAGMENT WHICH MAY HAVE BEEN A MARKER WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS BEING TREATED FOR ISCHEMIC CEREBRAL INFARCTION WHICH INCLUDED TANDEM LESIONS OF THE CCA AND M1 OCCLUSION. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT FLOW RESTORATION HAD PREVIOUSLY FAILED TO BE RESTORED FROM THE THROMBUS OF THE CCA WITH PLASMINOGEN ACTIVATOR (T-PA) THERAPY SO A COMPETITOR'S STENT WAS PLACED TO OPEN THE BLOOD VESSEL. ONCE THE BLOOD VESSEL WAS OPEN, THE MARKSMAN WAS ABLE TO BE DELIVERED TO THE M1 DISTAL REGION AND THE SOLITAIRE WAS DEPLOYED TO CAPTURE THE THROMBUS. THE DEVICE WAS PULLED HALFWAY BACK WITHOUT PROBLEMS BUT THEN THE SOLITAIRE GOT CAUGHT ON THE NON-MEDTRONIC STENT THAT WAS IN PLACE AND COULD NOT BE MOVED. IT WAS PULLED FORCIBLY AND WAS THEN ABLE TO BE MOVED AND THE SOLITAIRE WAS RETRIEVED. REVASCULARIZATION WAS ACHIEVED. HOWEVER, IN A POST-OP CT SCAN, IT WAS APPEARED THAT A FRAGMENT REMAINED IN THE PATIENT THAT MAY POSSIBLY HAVE BEEN A MARKER FROM A SOLITAIRE MARKER OR MARKSMAN MARKER. THE PATIENT DID NOT HAVE ANY IMMEDIATE RESIDUAL SYMPTOMS AT THE TIM

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10015508 ↗
• InjuryMay 5, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT OF SOLITAIRE 4X40 SEPARATION. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SOLITAIRE 4X40 WAS USED FOR 2 OR 3 PASSES IN THE M1/M2 JUNCTURE. AFTER REMOVING THE SOLITAIRE DEVICE, THE TECH NOTICED THE STENT WAS NOT ATTACHED TO THE PUSH WIRE (PROXIMAL MARKER). THE PHYSICIAN THEN DID AN ANGIO AND REALIZED THE STENT WAS LOCATED AND OPEN IN THE M1/M2 JUNCTURE. THE RIGHT MCA WAS OCCLUDED (M1/M2). THE PATIENT HAS EXPERIENCED A HEMORRHAGIC BLEED AND HAS BEEN DISCHARGED TO HOSPICE. THE ANATOMY WAS REPORTED TO HAVE BEEN MINIMAL IN TORTUOSITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8580905 ↗
• MalfunctionApr 11, 2019Break; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Break; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF SOLITAIRE PUSHWIRE DETACHMENT. THE PATIENT WAS UNDERGOING TREATMENT OF AN ISCHEMIC STROKE IN THE LEFT SUPERIOR DIVISION M2. THE PATIENT HAD A MODERATE VESSEL TORTUOSITY. STROKE ONSET TO REPERFUSION TIME WAS 4 HOURS. IT WAS REPORTED THAT DURING THE PROCEDURE, A SOLITAIRE WAS USED. THE DEVICE WOULD NOT TRACK BEYOND THE CAVERNOUS SEGMENT AND WAS REMOVED WITH THE INTERMEDIATE CATHETER. AFTER REMOVAL, THE DEVICE WAS FOUND TO BE FRAYED UPON INSPECTION. THERE WAS ALSO A PUSHWIRE BREAK/SEPARATION, WITH IT CONFIRMED THAT THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE. ALL BROKEN SEGMENTS WERE ABLE TO BE REMOVED FROM THE PATIENT. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE NOT PREPARED PER THE IFU AS THE MICROCATHETER WAS REMOVED OVER THE WIRE. MRS BASELINE AND PROCEDURE WAS 4, TICI SCORE BASELINE WAS 0 AND 3 POST PROCEDURE THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8506702 ↗
• DeathMar 15, 2017Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THE SOLITAIRE DETACHED IN THE PATIENT AND WAS LEFT IN THE M1/A1. THERE WAS NO ACCESS TO THE DEVICE TO MAKE A RETRIEVAL ATTEMPT. THE PROCEDURE WAS NOT COMPLETED AND THE VESSEL WAS NOT REVASCULARIZED. THE SOLITAIRE MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED TO TREAT THE LEFT MCA. THE VESSEL TORTUOSITY WAS EXTREMELY TORTUOUS. THE DEVICE WAS EXAMINED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THERE WAS NO RESISTANCE DURING ADVANCEMENT, HOWEVER THERE WAS SIGNIFICANT RESISTANCE DURING RETRIEVAL AND THE SOLITAIRE DETACHED AT THE PROXIMAL END; THE ENTIRE STENT PORTION WAS LEFT IN THE PATIENT. THE DEVICE WAS TORQUED DURING THE PROCEDURE. THE NIHSS PRE AND POST PROCEDURE IS NOT AVAILABLE AS THE PATIENT HAS EXPIRED.

  Patient problems: Death; No Known Impact Or Consequence To Patient

  MAUDE report 6407346 ↗