Solitaire™ X SFR4-6-40-10 (UDI 00763000425739)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00763000425739), received between Aug 27, 2021 and Sep 14, 2026 — classified as 2 deaths, 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Break

  Medtronic received a report that the Solitaire fractured and remained inside the patient's body. It was reported that when the physician used the SFR4-6-40 in (b)(6), a Solitaire device fractured and remained inside the patient's body. Due to patient privacy concerns (personal data protection), the physician is currently unwilling to disclose the patient's condition. There was separation. The patient had vessel stenosis proximal to the thrombus site. The stent remains in the patient's internal carotid artery (ICA). The pushwire was discarded by the hospital after the procedure and is not available for return. The physician did not attempt to detach the stent. It was unknown if there were any patient symptoms or complications associated with this event. It was unknown if the reported device and any accessory devices prepared as indicated in the IFU. The patient is alive with no injury. Ancillary devices include a Phenom microcatheter.

  Patient problems: Foreign Body In Patient; Stenosis

  MAUDE report 50753805 ↗
• MalfunctionFeb 9, 2026Break

  MEDTRONIC RECEIVED A REPORT THAT DURING MECHANICAL THROMBECTOMY FOR A STROKE INTERVENTION PROCEDURE, AFTER THE SECOND PASS WAS MADE WITH THE SOLITAIRE FR4 STENT RETRIEVER AND IT WAS TAKEN OUT, IT WAS NOTICED THAT THE DEVICE HAD COME APART VERTICALLY, WITH COMPLETE FRACTURE FROM TOP TO BOTTOM OF THE DEVICE. GOOD BLOOD FLOW WAS RESTORED TO THE BRAIN, SO ANOTHER DEVICE WAS NOT NEEDED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296837 ↗
• MalfunctionDec 8, 2025Break; Retraction Problem; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Retraction Problem; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE FR STENT ENCOUNTERED RESISTANCE, THERE WAS PUSHWIRE BREAK/SEPARATION, AND THE TIPS BROKE OFF IN M1 DURING RETRIEVAL. THE STENT REMAINED IN THE PATIENT AND THE BROKEN SEGMENT REMAINED IN M1. PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE REPORTED AS "M1 GONE POST STROKE WHEN SOLITAIRE BROKE". STROKE ONSET TO REPERFUSION TIME WAS REPORTED AS 0. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Stenosis

  MAUDE report 23743995 ↗
• MalfunctionNov 6, 2025Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE X STENT RETRIEVER THAT COULD NOT BE RESHEATHED AND WAS DAMAGED. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT ISCHEMIC STROKE. THE SOLITAIRE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE FIRST PASS WAS COMPLETED NORMALLY. OUTSIDE THE PATIENT'S BODY, THE SOLITAIRE WAS RINSED/CLEANED NORMALLY. HOWEVER, WHEN RESHEATHING, THE SOLITAIRE STENT COULD NOT BE RESHEATHED AND "CRUMPLED ON ITSELF." THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487996 ↗
• InjuryAug 15, 2025Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PHYSICIAN DID NOT FEEL THE DETACHED DEVICE HAD ANY EFFECT ON THE PATIENT OUTCOME. THE CAUSE OF THE EVENT WAS NOT DETERMINED. INITIALLY A CONTINUOUS SALINE FLUSH WAS NOT ADMINISTERED. HOWEVER, WHEN THIS WAS DISCOVERED, THE PHYSICIAN REMOVED AND DISCARDED THE CATHETER AND PULLED A NEW ONE WHERE CONTINUOUS FLUSH WAS MAINTAINED. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22821608 ↗
• MalfunctionJul 24, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE FR STENT SEPARATED FROM THE DELIVERY SYSTEM. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING THE THROMBECTOMY PROCEDURE, THE SOLITAIRE STENT BECAME DETACHED (BROKE OFF) FROM THE DELIVERY SYSTEM ON THE FIRST PASS. ANOTHER SOLITAIRE DEVICE WAS USED TO RETRIEVE THE ONE THAT HAD DETACHED INSIDE THE VESSEL AND THE PROCEDURE WAS COMPLETED USING A MEDTRONIC DEVICE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22589550 ↗
• MalfunctionJun 25, 2025Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF AN ISCHEMIC STROKE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, A SOLITAIRE STENT DETACHED AT THE SOFT WIRE PORTION OF THE DELIVERY PUSHER WIRE AND REMAINED IN THE PATIENT. THE PATIENT HAD A MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND WAS A CURRENT SMOKER. THE SOLITAIRE STENT WAS DEPLOYED FOR FIVE MINUTES, AND RESISTANCE WAS ENCOUNTERED DURING RETRIEVAL. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE STENT USING A DIFFERENT SOLITAIRE AND AN EMBOTRAP. THE PUSHWIRE BROKE AND SEPARATED AT THE DISTAL SECTION, BUT ALL BROKEN SEGMENTS OF THE PUSHWIRE WERE REMOVED FROM THE PATIENT. THE PROCEDURE DID NOT ACHIEVE REPERFUSION. THE PATIENT SURVIVED BUT SUSTAINED INJURY. THE SOLITAIRE REMAINS IN PATIENT.

  Patient problems: Foreign Body In Patient; Ischemia Stroke

  MAUDE report 22328660 ↗
• MalfunctionMay 16, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIREX6-40 ENCOUNTERED RESISTANCE IN THE DISTAL SHAFT OF THE PHENOM. STENT DISCONNECTION WAS ALSO NOTED AS THE SOLITAIRE DELIVERY PUSHER BECAME DISCONNECTED WHEN IT WAS PULLED INTO THE PHENOM OUTSIDE THE BODY. THE PATIENT WAS UNDERGOING THROMBECTOMY FOR TREATMENT OF AN ISCHEMIC CEREBRAL INFARCTION IN THE RIGHT M1. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA)/INTERNAL CAROTID ARTERY (ICA) WITH A 2-5MM DIAMETER. TICI (POSTOPERATIVE): NO PROBLEMS. THE PATIENT WAS TREATED WITH A TPS. THERE WERE 2 PASSES FOR THE SOLITAIRE. TIME REQUIRED FROM ONSET OF CEREBRAL INFARCTION TO REVASCULARIZATION/REVASCULARIZE WAS ABOUT 1 HOUR. IT WAS REPORTED THAT AFTER THE PRODUCT WAS DEPLOYED TO THE RIGHT M1 AND SUCCESSFUL REVASCULARIZATION WAS ACHIEVED, IT WAS DEPLOYED AT THE OCCLUSION OF THE RIGHT ICA AND THE SOLITAIREX WAS COLLECTED INTO THE PHENOM 21. HOWEVER, WHEN THE SOLITAIREX WAS ABOUT HALFWAY INSERTED INTO THE PHENOM 21, IT BECAME IMPOSSIBLE TO RETRACT IT. DURING SURGERY, IT WAS COLLECTED AS IS AND THE PROCEDURE WAS COMPLETED, BUT WHEN IT WAS PULLED INTO THE PHENOM 21 OUTSIDE THE BODY, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035881 ↗
• MalfunctionFeb 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356882 ↗
• InjuryAug 23, 2024Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT IS IN A STABLE CONDITION. THE CATHETER WAS A STRYKER EXCELSIOR XT-27. THE CAUSE OF THE KINK WAS UNKNOWN.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20049342 ↗
• InjuryJun 6, 2024Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT M1 OCCLUSION. D URING THE PROCEDURE, 2 STENTS WERE DEPLOYED, BUT THE SOLITAIRE STENT RETRIEVER BECAME STUCK ON THE CLOT, RESULTING IN A FRACTURE. AFTER THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE SIGNIFICANT LEFT-SIDED WEAKNESS. A CT ANGIOGRAM SHOWED THE RIGHT M1 OCCLUSION WITH A PERFUSION DEFECT. TENECTEPLASE (TNK) WAS GIVEN, BUT THE PATIENT STILL HAD SUBSTANTIAL LEFT-SIDED WEAKNESS, SO THE DECISION WAS MADE TO BRING THE PATIENT IN FOR A THROMBECTOMY.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 19479425 ↗
• MalfunctionJan 25, 2024Break; Separation Failure; Material Deformation; Break; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS USED TO REMOVE A CLOT AND WAS PERCEIVED THAT THE STENT WAS NO LONGER CYLINDRICAL IN SHAPE AND WAS DETACHED AND DAMAGED AFTER FIRST PASS. THERE WAS SEPARATION. THERE WAS ONE PASS MADE USING THIS STENT. THE STENT WAS REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE STENT. 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. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581576 ↗
• DeathNov 16, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT PASSED AWAY. THE SOLITAIRE WAS LEFT IN THE VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18154454 ↗
• InjuryOct 19, 2023Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) STATING THAT THE CAUSE OF THE SOLITAIRE RESISTANCE AND APRO CATHETER COLLAPSING IS UNKNOWN.

  Patient problems: Ischemia Stroke

  MAUDE report 17969411 ↗
• InjuryOct 19, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE SOLITAIRE WASN¿T THE CAUSE OF INFARCT. THE CLOT CAUSED THE INFARCTION.

  Patient problems: Ischemia Stroke

  MAUDE report 17969407 ↗
• MalfunctionSep 15, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE STENT WAS PULLED OUT OF PACKING AND STARTED TO PREP AND NOTICED THE SOLITAIRE WAS DAMAGED ON THE DISTAL END. THE DAMAGE WAS OBSERVED DURING PREP. THE DAMAGE WAS LOCATED ON THE STENT ITSELF. 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. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE PARENT VESSEL WAS THE M1 OCCLUSION WITH A DIAMETER OF 2.5MM. THE STROKE ONSET TO REPERFUSION TIME WAS 3 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755168 ↗
• MalfunctionMay 11, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS NO WIRE BASKET ON THE END OF THE WIRE. SO NO RETRIEVAL DEVICE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE LOCATED IN THE M1. THE PATIENT'S BASELINE AND POSTOPERATIVE MRS SCORE, NIHSS SCORE, AND TICI SCORES ARE UNKNOWN. IT IS UNKNOWN IF INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS CONTRAINDICATED. THERE WERE NO PASSES WITH THE DEVICE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS UNKNOWN. STROKE ONSET TO REPERFUSION TIME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912571 ↗
• InjuryApr 6, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE SEPARATED AND ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE OF THE LEFT M1 AND M2. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE LEFT MIDDLE CEREBRAL ARTERY WITH 2.5MM DIAMETER. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PERFORM MECHANICAL THROMBECTOMY ON A LEFT MIDDLE CEREBRAL ARTERY (MCA) DISTAL M1 SEGMENT. THE PHYSICIAN MADE TWO PASSES PER THE INSTRUCTIONS FOR USE (IFU). NO SIGNIFICANT FRICTION WAS NOTED DURING RETRIEVAL. NO CLOT WAS RETRIEVED AND THE VESSEL DID NOT OPEN. ON THE THIRD RETRIEVAL ATTEMPT, THERE WAS NOTICEABLY HIGHER FRICTION FELT AND THE DEVICE SEPARATED FROM THE DELIVERY WIRE. THE DEVICE REMAINS IN THE PATIENT. IT WAS UNKNOWN IF THE PATIENT HAD VESSEL STENOSIS PROXIMAL TO THE THROMBUS SITE. THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE. THREE PASSES WERE MADE WITH THE STENT. THERE WAS FRICTION OR DIFFICULTY DURING THE PROCEDURE. THE MICROCATHETER TIP COVERED THE STENT PROXIMAL MARKER DURING RETRIEVAL. THE STENT REMAINS IN THE PATIENT IN THE LEFT MCA. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PHYSICIAN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16693080 ↗
• MalfunctionMar 14, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE PUSHWIRE BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE LOCATED IN THE BASILAR ARTERY TO THE POSTERIOR COMMUNICATING ARTERY. THE PATIENT'S BASELINE MRS, NIHSS, AND TICI SCORES WERE 5, 25, AND 2A/3 RESPECTIVELY. POST PROCEDURE THESE WERE 5, 25, AND 2A/2 RESPECTIVELY. IV TPA WAS NOT CONTRAINDICATED. THREE PASSES WERE MADE WITH THE DEVICE. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE STROKE ONSET TO REPERFUSION TIME WAS 3 HOURS. IT WAS REPORTED THAT WHEN THE DOCTOR PULLED THE SOLITAIRE X BACK, IT WAS FOUND THAT THE DEVICE DID NOT MOVE AT POSTERIOR COMMUNICATING ARTERY AND THE PUSHWIRE WAS BROKEN FROM MIDDLE; THEREFORE, THE DOCTOR REPLACED WITH ANOTHER SOLITAIRE X AND TRIED TO RETRIEVE IT. THE SOLITAIRE X WAS REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THE DOCTOR THEN CHECKED THE DEFECTIVE SOLITAIRE X AND FOUND THE PUSHWIRE WAS BROKEN AT THE MIDDLE WITHOUT DEFORMATION. NO RESISTANCE HAD BEEN ENCOUNTERED. THE PUSHWIRE HAD BEEN TORQUED DURING THE PROCEDURE, AND ALL BROKEN SEGMENTS WERE REMOVED FROM THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537941 ↗
• InjuryJan 17, 2023Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT REGARDING A SOLITARE STENT SEPARATION, PREMATURE DETACHMENT, AND PUSHWIRE BREAK/SEPARATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PATIENTS MRS BASELINE SCORE WAS 0. THE MRS SCORE DURING THE PROCEDURE WAS 4. THE PATIENTS NIHSS SCORE BASELINE WAS 12 AND POST PROCEDURE THE NIHSS SCORE REMAINED AT 12. THE BASELINE TICI SCORE WAS 0 AND POST PROCEDURE THE TICI SCORE WAS 0. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS CONTRAINDICATED. THERE WERE TWO PASSES WITH THE DEVICE. STROKE ONSET WAS AT 0930 AND THE FIRST PASS WAS AT 1145. IT WAS REPORTED THAT SOLITAIRE BROKE OFF UPON RETRIEVAL OF A CLOT ON 2ND PASS. IT WAS REPORTED SEPARATION OCCURRED. THE PATIENT HAD VESSEL STENOSIS PROXIMAL TO THE THROMBUS SITE. THE PUSH WIRE WAS NO TORQUED DURING THE PROCEDURE. THERE WERE TWO PASSES MADE USING THIS STENT. THERE WAS NO FRICTION OR DIFFICULTYDURING THE PROCEDURE. THE MICROCATHETER TIP DID NOT COVER THE STENT PROXIMAL MARKER DURING RETRIEVAL. THE STENT REMAINS IN THE PATIENT IN THE RIGHT MIDDLE CEREBRAL ARTERY. THERE WAS NO SURG

  Patient problems: Foreign Body In Patient

  MAUDE report 16185191 ↗
• MalfunctionDec 29, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING A SOLITARE STENT THAT HAD RESISTANCE DURING RETRIEVAL AND SEPARATED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT'S MRS BASELINE WAS 2. THE PATIENT'S MRS DURING THE PROCEDURE WAS 0. THE NIHSS SCORE BASELINE AND POST PROCEDURE ARE UNKNOWN. THE TICI SCORE BASELINE WAS 0. THE TICI SCORE POST PROCEDURE WAS 2A. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT CONTRAINDICATED. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. STROKE ONSET TO REPERFUSION TIME WAS APPROXIMATELY THREE HOURS. THE PATIENT HAD A HISTORY OF A CLOTTING DISORDER. IT WAS REPORTED THAT THE INITIAL PLAN TO PLACE DEVICE IN PROXIMAL M1 CLOT. CLOT HAD SOMEWHAT MIGRATED, SO PLACED DEVICE IN PROXIMAL M2/DISTAL M1. PHYSICIAN BEGAN TO PULL BACK DEVICE TO RETRIEVE CLOT AND HAD SUBSTANTIAL RESISTANCE. DEVICE FINALLY PULLED OUT OF M2 SEGMENT AND THEN WHEN PULLING WITH LESS RESISTANCE FROM M1 INTO ICA, THE STENT SEPARATED FROM THE DELIVERY WIRE. DUE TO PATIENT CONDITION AND FEAR OF BLEEDING, NO ATTEMPT MADE TO RETRIEVE DEVICE. PATIENT DISCHARGED FROM HOSPITAL ON ASPIRIN AND NIHSS BACK TO 0. IT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067912 ↗
• DeathSep 13, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE X STENT THAT DETACHED IN THE PATIENT. THE PATIENT WAS UNDERGOING A PROCEDURE TO TREAT M1 OCCLUSION WITH HARD PLAQUE. THERE WAS NO NOTED STENOSIS PROXIMAL TO THE OCCLUSION SITE. PRE-PROCEDURE MRS WAS 0, NIHSS WAS 22, AND TICI WAS 0. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT SOLITAIRE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN FIRST ATTEMPTED TO ASPIRATED THE PLAQUE WITH A NON-MEDTRONIC CATHETER BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN PLACED THE SOLITAIRE X TO ATTEMPT AND RETRIEVE THE PLAQUE. THE FIRST ATTEMPT WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS MADE WITH THE SOLITAIRE. THE DEVICE GOT STUCK AND BROKE OFF IN THE PATIENT. NO ATTEMPT HAD BEEN MADE TO DETACH THE STENT. IT WAS NOTED THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PUSHWIRE WAS NOT TORQUED. THE MICROCATHETER TIP COVERED THE STENT PROXIMAL MARKER DURING RETRIEVAL. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SOLITAIRE WITH AN AMPLATZ GOOSENECK SNARE BUT WAS UNSUCCESSFUL. THEN STENT REMAINED IN THE M1 VESSEL SEGMENT. POST-PROCEDURE MRS WAS 5, NIHSS WAS 30, AND TICI REMAINED 0.

  Patient problems: Device Embedded In Tissue or Plaque; Stroke/CVA; Unspecified Nervous System Problem

  MAUDE report 15412435 ↗
• InjurySep 8, 2022Break; Break

  ADDITIONAL INFORMATION THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15381244 ↗
• MalfunctionAug 31, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE PUSHER BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE LOCATED IN THE RIGHT M1 SEGMENT. IV TPA WAS NOT CONTRAINDICATED. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PARENT VESSEL WAS THE MIDDLE CEREBRAL ARTERY. THE STROKE ONSET TO REPERFUSION TIME WAS 5 HOURS. IT WAS REPORTED THAT AFTER COMPLETING ONE PASS WITH THE DEVICE THEY PUSHED THE END OF THE STENT OUT OF THE GUIDE CATHETER AND TRIED TO PULL IT OUT, BUT THE ENTIRE STENT BROKE OFF. THIS HAPPENED OUTSIDE OF THE BODY AND THE PATIENT WAS FINE. ONE PASS WITH THE DEVICE ACHIEVED A FINAL TICI SCORE OF 3, SO A REPLACEMENT DEVICE WAS NOT NEEDED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A STRYKER CAT5 GUIDE CATHETER AND MARKSMAN MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331847 ↗
• MalfunctionJul 19, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A SOLITAIRE DEVICE HAD DIFFICULTY RECAPTURING DURING A THROMBECTOMY. THE PHYSICIAN FELT RESISTANCE WHEN THE SFR ENTERED THE MICROCATHETER. UPON INSPECTION, IT APPEARS TO BE A PARTIAL (TO NEAR COMPLETE) FRACTURE OF THE DEVICE FROM THE WIRE. EVERYTHING WAS REMOVED FROM PATIENT AND STILL IN THE MICROCATHETER. THE PUSHWIRE BROKE/SEPARATED. THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED. ALL BROKEN SEGMENTS OF THE PUSHWIRE WERE REMOVED AS ALL WERE IN THE MICROCATHETER WHEN IT WAS REMOVED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS TREATED FOR AN ISCHEMIC STROKE IN THE M1 LOCATION. 2 PASSES WERE MADE WITH THE DEVICE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059898 ↗