Solitaire™ X SFR4-6-40-10 (UDI 00847536034730)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00847536034730), received between May 21, 2019 and Mar 18, 2026 — classified as 16 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (16 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break; Retraction Problem

  MEDTRONIC RECEIVED A REPORT OF SOLITAIRE STENT PUSHWIRE BREAK AND RESISTANCE WITH THE MARKSMAN MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE IN THE A3 REGION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED. THE NUMBER OF PASSES WITH THE DEVICE WAS 2. IT WAS REPORTED THAT AFTER THE MICROCATHETER REACHED THE THROMBUS LOCATION, THE SOLITAIRE FR STENT WAS DELIVERED THROUGH THE THROMBUS. AFTER WAITING FOR INTEGRATION, THE STENT WAS PULLED TO PERFORM THROMBECTOMY. THE FIRST PULLING WAS SMOOTH. DURING THE SECOND PULLING, THE STENT BECAME STUCK IN THE MARKSMAN MICROCATHETER AND COULD NOT BE WITHDRAWN. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE OPERATOR GAVE A FORCEFUL PULL, RESULTING IN FRACTURE OF THE PROXIMAL END OF THE STENT AND BREAKAGE OF THE DELIVERY WIRE, WITH THE STENT STUCK INSIDE THE MICROCATHETER. THE STENT AND THE MICROCATHETER WERE THEN REPLACED, AND THE THROMBECTOMY WAS COMPLETED. THERE WAS PUSHWIRE BREAK/SEPARATION IN THE DISTAL SECTION. ALL BROKEN SEGMENTS OF THE PUSHWIRE WERE REMOVED FROM THE PATIENT. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT'S BO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626393 ↗
• MalfunctionMay 27, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THROMBECTOMY 3 TIMES, THE RESISTANCE TO STENT RETRIEVAL INCREASED. AFTER THE STENT WAS REMOVED, IT WAS FOUND TO BE DEFORMED, SO THE STENT WAS REPLACED AND THE THROMBECTOMY WAS PERFORMED AGAIN. THERE WAS STENT DAMAGE DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED. THE MIDDLE PART OF THE STENT WAS KINKED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC STROKE LOCATED IN THE MIDDLE CEREBRAL ARTERY (MCA). IV TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT CONTRAINDICATED. THERE WERE 3 PASSES WITH THE DEVICE. THE PARENT VESSEL WAS 4MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. STROKE ONSET TO REPERFUSION TIME WAS 4 HOURS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088912 ↗
• InjuryMay 19, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE STENT RETRIEVER THAT HAD RESISTANCE AT THE Y-VALVE AND WAS DAMAGED. THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT ISCHEMIC STROKE AND RETRIEVE THROMBUS OCCLUSION LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY BIFURCATION, C6 AND C7 SEGMENTS. THE PATIENT'S BASELINE MRS 3, NIHSS WAS 15, TICI WAS 0. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER THE MICROCATHETER WAS DELIVERED IN PLACE, THE SOLITAIRE STENT RETRIEVER WAS SELECTED AND HYDRATED. WHILE ATTEMPTING TO ADVANCE THE SOLITAIRE STENT THROUGH THE Y-VALVE AT THE PROXIMAL END OF THE MICROCATHETER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE ANGLE WAS ADJUSTED BUT THE RESISTANCE CONTINUED. THE SOLITAIRE WAS WITHDRAWN. IN VITRO, WHEN THE SOLITAIRE WAS PUSHED OUT OF THE SHEATH, IT WAS FOUND THAT THE PUSHWIRE WAS BENT/TWISTED WHERE THE WIRE CONNECTS TO THE STENT, SO THE SOLITAIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TICI 5 ACHIEVED. THOUGH IT WAS NOTED THERE WAS NO PATIENT INJURY OR COMPLICATION ASSOCIATED WITH THIS EVENT, THERE WAS A DECLINE IN PATIENT'S POST-OP

  Patient problems: Muscle Weakness/Atrophy; Nervous System Injury

  MAUDE report 22043187 ↗
• MalfunctionJan 3, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. CATHETER RESISTANCE OCCURRED IN THE REMOTE MIDDLE SECTION. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE INTERMEDIATE CATHETER AND MICROCATHETER WERE NOT MEDTRONIC PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071152 ↗
• MalfunctionNov 7, 2024Break; Packaging Problem; Physical Resistance/Sticking; Break; Packaging Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PROCEDURE WAS COMPLETED USING ANOTHER DEVICE FROM A DIFFERENT BRAND. THE CAUSE OF THE SOLITAIRE RESISTANCE/DAMAGE WAS UNABLE TO BE DETERMINED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629280 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A SOLITAIRE SFR4 STENT HAD COMPLICATIONS. HEAD COMPUTER TOMOGRAPHY (CT) WITHOUT CONTRAST, DIAGNOSTIC TEST RESULT: COMPRESSION NARROWED THE RIGHT VENTRICLE AND RIGHT LATERAL FISSURE CISTERNA. CT REEXAMINATION ON (B)(6) 2024 SHOWED INCREASED CEREBRAL EDEMA. DECOMPRESSIVE CRANIECTOMY WAS PERFORMED ON (B)(6) 2024. THE PATIENT WAS HOSPITALIZED AND INTERVENTION WAS REQUIRED. THE EVENT IS NOT RESOLVED. THE EVENT WAS POSSIBLY RELATED TO THE STUDY PROCEDURE.   PRE-PROCEDURE MTICI SCORE: INDETERMINATE. FINAL POST-PROCEDURE MTICI SCORE: 3.

  Patient problems: Cerebral Edema; Vasoconstriction

  MAUDE report 19481527 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT EXPERIENCED A CEREBRAL ARTERY EMBOLISM IN THE SAME TERRITORY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THERE WAS NO TREATMENT OR ACTIONS REQUIRED. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERED/RESOLVED. THE ADVERSE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY AND NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE SITE ASSESSED THE ADVERSE EVENT AS NOT RELATED TO THE DEVICES OR STUDY PROCEDURE. THE SPONSOR ASSESSED THE ADVERSE EVENT AS CASUALLY RELATED TO THE STUDY PROCEDURE AND POSSIBLE RELATED TO THE DEVICE UTILIZED.

  Patient problems: Embolism/Embolus

  MAUDE report 19277115 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO INTERVENTION WAS PERFORMED TO TREAT THE PROCEDURE COMPLICATIONS.

  Patient problems: Nervous System Injury

  MAUDE report 19228732 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG CANNOT BE FLIPPED TO 'NO' AS A REGULATORY REPORT EXISTS IN THIS PE.

  Patient problems: Nervous System Injury

  MAUDE report 19226228 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT DURING THE SUBJECT'S INDEX PROCEDURE ON (B)(6) 2024, INTRACRANIAL STENTING AND ANGIOPLASTY WERE PERFORMED AFTER MECHANICAL THROMBECTOMY TO TREAT AN UNSPECIFIED PROCEDURAL COMPLICATION. THE PATIENT'S BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS 7, DISCHARGE NIHSS 9. FINAL MTICI POST PROCEDURE 3. IT IS UNKNOWN IF THERE WAS ANY IMPACT TO THE PATIENT. IT WAS UNKNOWN IF ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. IT WAS UNKNOWN IF THERE WAS AN ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE INVESTIGATOR, SPONSOR, OR CLINICAL EVENTS COMMITTEE (CEC).

  Patient problems: Nervous System Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221660 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING THE SUBJECT'S INDEX PROCEDURE ON (B)(6) 2024, INTRACRANIAL STENTING AND ANGIOPLASTY WERE PERFORMED AFTER MECHANICAL THROMBECTOMY TO TREAT AN UNSPECIFIED PROCEDURAL COMPLICATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC STROKE LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE PATIENT'S BASELINE TICI SCORE WAS INTERMEDIATE, TICI SCORE POST PROCEDURE WAS 3. STROKE ONSET TO REPERFUSION TIME WAS (B)(6) 2024 AT 8:30 TO (B)(6) 2024 AT 12:45.

  Patient problems: Nervous System Injury

  MAUDE report 19221575 ↗
• MalfunctionNov 11, 2021Break; Break

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THE SOLITAIRE X STENT DETACHED IN THE PATIENT WHEN THE PHYSICIAN ATTEMPTED TO PULL IT. IT WAS NOTED THAT THE SOLITAIRE DEVICE AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  2 PASSES HAD BEEN MADE WITH THE DEVICE. IT WAS NOT INDICATED IF THE SOLITAIRE WAS LEFT IN THE PATIENT OR ABLE TO BE REMOVED, HOWEVER IT WAS REPORTED THAT THE PATIENT HAD NO SYMPTOMS, INJURIES, OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE IN THE M1 TO TREAT ISCHEMIC STROKE. VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICE: PHENOM 27 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 12798615 ↗
• MalfunctionJul 31, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE FR 4 EXPERIENCED RESISTANCE IN A PHENOM 21 MICROCATHETER, AND IT WAS LATER FOUND TO BE DAMAGED. THE PATIENT WAS UNDERGOING TREATMENT FOR A MECHANICAL THROMBECTOMY. PATIENT MEDICAL HISTORY INCLUDED STROKE. IT WAS REPORTED THAT ONE PASS WAS PERFORMED USING THE PHENOM 21 MICROCATHETER AND RESISTANCE WAS PERCEIVED. THE PHYSICIAN REPLACED WITH CATHETER WITH A MICROVENTION .027 CATHETER, AND THE DEVICE TRAVELED MORE SMOOTHLY. AFTER TWO MORE PASSES THE DEVICE WAS NOTED TO HAVE BEEN BROKEN AND THE PLASTIC SHEATH WAS STUCK TO THE PUSHER WIRE. THE SOLITAIRE WAS REPLACED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND A TICI SCORE OF 2B/C WAS ACHIEVED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO KINK OR DAMAGE ON THE CATHETER. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER. IT WAS STATED THE DEVICE WAS NOT FLUSHED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT RESISTANCE WAS FELT IN THE MIDDLE PART OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257056 ↗
• MalfunctionJul 23, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER REMOVING THE SOLITAIRE FROM THE BODY, ON THE THIRD PASS, IT WAS HARD TO PULL FROM THE CATHETER TO CHECK IT FOR CLOT. IT WAS NOTICED THAT IT HAD FRAYED ON THE END. IT LOOKED LIKE IT PULLED APART FROM THE MARKERS AT THE END, AND WAS ALSO WAS VERY COMPRESSED IN THE CENTER OF THE STENT RETRIEVER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12220925 ↗
• MalfunctionApr 23, 2021Display or Visual Feedback Problem; Physical Resistance/Sticking; Display or Visual Feedback Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE DISTAL PART OF THE CATHETER. THERE WAS NO DAMAGE TO THE SOLITAIRE PUSHWIRE, AND THERE WAS SOME MINOR DAMAGE AT THE TIP OF THE CATHETER, LIKELY DUE TO THE TENSION APPLIED TO TRY TO REMOVE THE STENT RETRIEVER. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER, AND THERE WERE NO PROBLEMS WITH INSERTION. THE DEVICES HAD BEEN PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720209 ↗
• InjuryApr 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE WOULD NOT COME OUT OF THE CATHETER AND COULD BARELY BE BROUGHT BACK INTO THE SHEATH. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN NOTED THAT THEY HAD THE OPINION THAT PERHAPS IT WAS A ¿ROCK¿ THAT DISLODGED DUE TO THE PATIENT¿S TAVR PROCEDURE THEY HAD 6MOS PRIOR. THE RESISTANCE WAS FELT AT THE STENT RETRIEVER, AND THAT BROKEN OFF RETRIEVER WAS LEFT BEHIND IN PATIENT. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL AND THAT THE DEVICES WERE PREPARED PER THE IFU.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11703943 ↗
• InjuryApr 15, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE BROKE OFF AT THE WELD POINT OF THE STENT AND THE PUSHER WIRE. THERE WERE NO ISSUES PRIOR, AND THE DOCTOR FELT RESISTANCE WHEN PULLING DEVICE BACK AND USED A LOT OF FORCE. THE DEVICE WAS LEFT IN THE PATIENT IN THE DISTAL ICA.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11676247 ↗
• InjuryMar 24, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT SOLITAIRE BROKE OFF IN THE SOFIA CATHETER AND WAS NOT LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563362 ↗
• MalfunctionMar 4, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. ONE PASS WAS MADE WITH THE SOLITAIRE PRIOR TO SEPARATION. RESISTANCE WAS FELT WHEN PULLED THE SOLITAIRE BACK TO THE REACT CATHETER TIP, THIS WAS WHEN THE FRACTURE OCCURRED. THE SOLITAIRE WAS NOT TORQUED OR REPOSITIONED DURING DELIVERY OR RETRIEVAL. THE PATIENT DID NOT HAVE ANY REPORTED STENOSIS, HOWEVER, SMALL VESSELS AND TORTUOSITY WERE NOTED. THE MICROCATHETER TIP DID NOT COVER THE SOLITAIRE DEVICE PROXIMAL MARKER DURING THE ATTEMPTED RETRIEVAL. THE CLOT CHARACTERISTICS WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11414544 ↗
• MalfunctionMar 2, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE SEPARATION OCCURRED DURING THE SECOND OR THIRD PASS. THERE WAS RESISTANCE FELT DURING RETRIEVAL OF THE SOLITAIRE. THE DEVICE WAS NOT TORQUED OR REPOSITIONED. POST-OPERATIVELY, THE PHYSICIAN DID THINK THERE MAY HAVE BEEN SOME STENOSIS PROXIMAL TO THE THROMBUS THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE MICROCATHETER TIP DID NOT COVER THE SOLITAIRE PROXIMAL MARKER DURING RETRIEVAL. THERE WAS NOTHING REMARKABLE ABOUT THE CONDITION OF THE CLOT. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11400134 ↗
• InjuryFeb 8, 2021Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THE SOLITAIRE STENT BROKE/FRACTURED OFF IN THE DISTAL MIDDLE CEREBRAL ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 11294767 ↗
• MalfunctionJan 29, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE STENT BECAME STRETCHED AND STUCK INSIDE THE INTERMEDIATE CATHETER; THE SOLITAIRE RESISTANCE OCCURRED ABOUT 2-3 CM INTO THE CATHETER. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE TIP OF THE SHEATH WAS SECURED IN THE HUB OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT OF AN ICA-MCA OCCLUSION. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL AND THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. ANCILLARY DEVICE: SOFIA 5FR 125CM CATHETER ***EVENT REPORTABLE DUE TO ANALYSIS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253269 ↗
• InjuryJan 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED PATIENT CONDITION, AND MEDICAL OR SURGICAL INTERVENTION, AND/OR OUTCOME WOULD NOT BE REPORTED DUE TO CONFIDENTIALITY/PRIVACY REASONS. THERE WAS NO KINK OR DAMAGE OBSERVED TO THE PUSHWIRE OF THE SOLITAIRE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11137292 ↗
• MalfunctionNov 19, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10868062 ↗
• InjurySep 3, 2020Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PATIENT VESSEL TORTUOSITY WAS MODERATE TO SEVERE. THE SOLITAIRE FR STENT DETACHED AT THE PUSHWIRE AFTER THE FINAL PASS SO THE THROMBECTOMY PROCEDURE WAS COMPLETED. NO INTERVENTION WAS PLANNED TO REMOVE THE STENT. TISSUE PLAMINOGEN ACTIVATOR (TPA) MEDICATION WAS CONTRAINDICATED SO THE PATIENT WAS ON APIXABAN. THE PATIENT'S STROKE FINDINGS APPEARED IMPROVED ON FOLLOW-UP MRI BUT CLINICAL SYMPTOMS REMAINED. THE PHYSICIAN REPORTED THERE WERE NO ADVERSE INJURY/PATIENT SYMPTOMS RELATED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10490115 ↗