Solitaire™ X SFR4-3-20-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000367619), received between Nov 1, 2023 and Nov 11, 2025 — classified as 6 deaths, 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A NON-MEDTRONIC INTERMEDIATE CATHETER WAS ADVANCED TO THE DISTAL PORTION OF M1. THROMBECTOMY WAS ATTEMPTED SEVERAL TIMES USING A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT), BUT THE THROMBUS COULD NOT BE RETRIEVED, SO THE SOLITAIRE FR THROMBUS RETRIEVAL STENT (SFR) WAS USED TO PERFORM A COMBINED TECHNIQUE. WHEN THE SFR WAS INSERTED INTO A NON-MEDTRONIC MICROCATHETER AND THE PUSH WIRE WAS PRESSED, THERE WAS A STRONGER RESISTANCE THAN USUAL. WHILE RESISTANCE WAS FELT, THE PUSH WIRE WAS CONTINUOUSLY ADVANCED, RESULTING IN THE SFR BECOMING STUCK WITHIN THE CATHETER. ALL MICROCATHETERS WERE REMOVED AND REPLACED WITH NEW ONES OF THE SAME MODEL. ADAPT WAS PERFORMED AGAIN USING A NON-MEDTRONIC INTERMEDIATE CATHETER, RESULTING IN RECANALIZATION, AND THE PROCEDURE WAS SAFELY COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING THROMBECTOMY SURGERY FOR TREATMENT OF POOR BLOOD FLOW IN THE DISTAL (M2) SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED AN 8F OPTIMA GUIDECAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525946 ↗
• MalfunctionMay 28, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION CHARACTERISTICS INCLUDED THE DISTAL MIDDLE CEREBRAL ARTERY. VESSEL TORTUOSITY WAS MINIMAL. REGARDING THE CAUSE OF THE EVENT, THERE WAS PRELIMINARY JUDGMENT OF THROMBUS ESCAPE AT THE PROXIMAL FRACTURE OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095601 ↗
• MalfunctionMar 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE MICROCATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644160 ↗
• MalfunctionFeb 10, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE/DAMAGE WAS NOT DETERMINED. THE PATIENT¿S BASELINE (TICI, N IHSS ETC.): TICI LEVEL 1, NIHSS 9 POINTS. THE PATIENT¿S POST-THROMBECTOMY CONDITION (TICI, NIHSS, ETC.): TICI LEVEL 3, NIHSS 1 POINT. THE STENT WAS KINKED AND SEVERELY DEFORMED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349578 ↗
• MalfunctionDec 30, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE RESISTANCE WAS NEAR THE MIDDLE OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035738 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE PATIENT EXPERIENCED A HEMORRHAGIC TRANSFORMATION. HEAD COMPUTER TOMOGRAPHY (CT) WITHOUT CONTRAST WAS CLINICALLY SIGNIFICANT ON (B)(6) 2024. THE PATIENT DID NOT RECOVER/RESOLVE. TRACTION BLEEDING COULD NOT BE RULED OUT. A FEW HIGH-DENSITY LESIONS IN THE LEFT MIDDLE CEREBRAL ARTERY SUPPLY AREA ARE PARTIALLY INCREASED AND PARTLY DECREASED. SOME CONTRAST EXUDATION AND PARTIAL HEMORRHAGE ARE CONSIDERED. PATIENT DETAILS: MRS SCORE 0, NIHSS SCORE AVAILABLE: 19. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED A FINAL MTICI 3. AND CAUSALITY ASSESSMENT PROVIDED AS: POSSIBLE RELATED TO PROCEDURE / PROBABLE RELATED TO UNDERLYING CONDITION OR DISEASE. THE PATIENT¿S DEATH ON (B)(6) 2024 WAS REPORTED. HOWEVER, IT WAS LATER REPORTED THAT THE DEATH OF THE SUBJECT WAS NOT RELATED TO INSTRUMENTS OR SURGERY. CONSIDERING THE PATIENT¿S ADVANCED AGE, POTENTIAL DISEASE CONDITION, AND POTENTIAL PHYSICAL CONDITION, DEATH MAY BE RELATED TO THE STUDIED DISEASE AND POTENTIAL DISEASE. THE PATIENT'S INITIAL TREATMENT WAS A THROMBECTOMY OF THE LEFT MIDDLE CEREBRAL ARTERY AND THE LEFT ANTERIOR CEREBRAL ARTERY. THIS F

  Patient problems: Extravasation; Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 19690894 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED DURING THE POSTOPERATIVE WITHDRAWAL OF THE ACCESS CATHETER, THE ACCESS THROMBOSIS APPEARED AND ESCAPED TO THE ANTERIOR CEREBRAL ARTERY, WHICH WAS RECONNECTED AFTER THROMBOLYSIS THROUGH THE ANTERIOR CEREBRAL ARTERY STENT.

  Patient problems: Thromboembolism

  MAUDE report 19630496 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE SUBJECT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 DUE TO SUDDEN UNCONSCIOUSNESS FOR 4 HOURS. HEAD, CHEST, AND UPPER ABDOMEN SCAN WERE PERFORMED TO SHOW THE SUBJECT'S STROKE. DURING THE OPERATION, THE SUBJECT UNDERWENT MECHANICAL THROMBECTOMY, AND THE THROMBUS ESCAPED TO THE M2-L SEGMENT WHEN THE THROMBUS WAS EXTRACTED. AFTER MECHANICAL THROMBECTOMY AND THE MICROCATHETER THROMBECTOMY, THE M2-L SEGMENT WAS REEVACUATED. THE EVENT WAS NOT A RECURRENT OR NEW STROKE. THE EVENT WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY AND UNDERLYING CONDITION OR DISEASE. THE EVENT DID NOT RESULT FROM A DEVICE DEFICIENCY. PRE-PROCEDURE MTICI WAS INTERMEDIATE AND POST PROCEDURE WAS 3. THERE WAS TREATMENT. THE OUTCOME WAS RECOVERED/RESOLVED ON (B)(6) 2024. THE SITE ASSESSED AS NOT RELATED TO THE PROCEDURE OR DEVICES, HOWEVER, THE SPONSOR ASSESSED THE EVENT AS SERIOUS AND CAUSALLY RELATED TO THE STUDY PROCEDURE AND POSSIBLY TO THE DEVICES UTILIZED.

  Patient problems: Thromboembolism

  MAUDE report 19191904 ↗
• DeathApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF A SOLITAIRE PATIENT DEATH. ON (B)(6) 2024, A TELEPHONE FOLLOW-UP WAS CONDUCTED, AND IT WAS LEARNED THAT THE PATIENT'S CURRENT STATUS WAS DEATH. THE DATE OF DEATH WAS (B)(6) 2024. PATIENT DETAILS: MRS SCORE: 0, NIHSS SCORE AVAILABLE: 19. LOCATION OF PROXIMAL FACE OF CLOT 1: PRE-PROCEDURE MTICI SCORE: 0, FINAL POST-PROCEDURE MTICI SCORE: 3. NO PROBLEM DETECTED ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM DEVICE NOT RETURNED ISCHEMIA STROKE NO FINDINGS AVAILABLE ISCHEMIA STROKE DEATH STENT POST PROCEDURE COMPLICATION GENERAL_POST-PROCEDURAL COMPLICATION.

  Patient problems: Ischemia Stroke

  MAUDE report 19154377 ↗
• DeathApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE LOCATION THAT THE PATIENT PASSED AWAY, AND INFORMATION ABOUT IF AUTOPSY RECORDS ARE AVAILABLE WAS UNKNOWN. CAUSALITY ASSESSMENT PROVIDED AS : NOT RELATED TO THE PROCEDURE OR DEVICE; POSSIBLE RELATED TO DISEASE UNDER STUDY AND UNDERLYING CONDITION OR DISEASE. THERE WAS NO HOSPITALIZATION AND NO TREATMENT LEADING UP TO THE PATIENT¿S DEATH. PATIENT DEATH FROM UNKNOWN CAUSE.

  Patient problems: Ischemia Stroke

  MAUDE report 19154373 ↗
• DeathApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE LOCATION THAT THE PATIENT PASSED AWAY, AND INFORMATION ABOUT IF AUTOPSY RECORDS ARE AVAILABLE WAS UNKNOWN. CAUSALITY ASSESSMENT PROVIDED AS : NOT RELATED TO THE PROCEDURE OR DEVICE; POSSIBLE RELATED TO DISEASE UNDER STUDY AND UNDERLYING CONDITION OR DISEASE. THERE WAS NO HOSPITALIZATION AND NO TREATMENT LEADING UP TO THE PATIENT¿S DEATH. PATIENT DEATH FROM UNKNOWN CAUSE.

  Patient problems: Ischemia Stroke

  MAUDE report 19154366 ↗
• DeathApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE PATIENT DEATH. THE AE DID NOT RESULT FROM A DEVICE DEFICIENCY. OTHER ACTIONS TAKEN: CAR DIOPULMONARY, RESUSCITATION, TRACHEAL INTUBATION AND CARDIAC STRENGTH. ON (B)(6) 2024 23:40 THE PATIENT EXPERIENCED SUDDEN SHOCK. THE PATIENT WAS CRITICALLY ILL WITH RESPIRATORY AND CIRCULATORY FAILURE AND DIED ON THE DAY OF DISCHARGE. PATIENT DETAILS: MRS SCORE: 0 NIHSS SCORE AVAILABLE: 18.

  Patient problems: Respiratory Failure; Shock

  MAUDE report 19139391 ↗
• DeathApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A RIGHT BASAL GANGLIA INFARCT WITH LITTLE HEMORRHAGE TRANSFORMATION SHOWN ON HEAD CT WITHOUT CONTRAST ON (B)(6) 2024 POST PROCEDURE. THE EVENT WAS NOT A RECURRENT OR NEW STROKE. THERE WAS NO TREATMENT OR OTHER ACTIONS TAKEN. THE OUTCOME STATUS WAS NOT RECOVERED/NOT RESOLVED. THE EVENT RELATIONSHIP TO THE DISEASE UNDER STUDY WAS PROBABLE AND NOT RELATED TO AN UNDERLYING CONDITION ON DISEASE. THE EVENT DID NOT RESULT FROM A DEVICE DEFICIENCY. THE MRS SCORE WAS 0 AND NIHSS WAS 15. PRE-PROCEDURE MTICI WAS 0 AND POST PROCEDURE WAS 3. THE SITE ASSESSED AS NOT RELATED TO THE DEVICE OR PROCEDURE, HOWEVER, THE SPONSOR ASSESSED AS POSSIBLY RELATED TO THE STUDY PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke

  MAUDE report 19136143 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE PATIENT EXPERIENCED A HEMORRHAGIC TRANSFORMATION. HEAD COMPUTER TOMOGRAPHY (CT) WITHOUT CONTRAST WAS CLINICALLY SIGNIFICANT ON (B)(6) 2024. THE PATIENT DID NOT RECOVER/RESOLVE. TRACTION BLEEDING COULD NOT BE RULED OUT. A FEW HIGH-DENSITY LESIONS IN THE LEFT MIDDLE CEREBRAL ARTERY SUPPLY AREA ARE PARTIALLY INCREASED AND PARTLY DECREASED. SOME CONTRAST EXUDATION AND PARTIAL HEMORRHAGE ARE CONSIDERED. PATIENT DETAILS: MRS SCORE 0, NIHSS SCORE AVAILABLE: 19. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE PROCEDURE. HEMORRHAGE POST PROCEDURE COMPLICATION MINOR INJURY/ILLNESS/IMPAIRMENT NO PROBLEM DETECTED DEVICE NOT RETURNED NO FINDINGS AVAILABLE HEMORRHAGE/BLOOD LOSS/BLEEDING ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM GENERAL POST-PROCEDURAL COMPLICATION STENT.

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 19095862 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE PATIENT EXPERIENCED A HEMORRHAGIC TRANSFORMATION. HEAD COMPUTER TOMOGRAPHY (CT) WITHOUT CONTRAST WAS CLINICALLY SIGNIFICANT ON (B)(6) 2024. THE PATIENT DID NOT RECOVER/RESOLVE. TRACTION BLEEDING COULD NOT BE RULED OUT. A FEW HIGH-DENSITY LESIONS IN THE LEFT MIDDLE CEREBRAL ARTERY SUPPLY AREA ARE PARTIALLY INCREASED AND PARTLY DECREASED. SOME CONTRAST EXUDATION AND PARTIAL HEMORRHAGE ARE CONSIDERED. PATIENT DETAILS: MRS SCORE 0, NIHSS SCORE AVAILABLE: 19. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE PROCEDURE. HEMORRHAGE POST PROCEDURE COMPLICATION MINOR INJURY/ ILLNESS / IMPAIRMENT NO PROBLEM DETECTED DEVICE NOT RETURNED NO FINDINGS AVAILABLE HEMORRHAGE/BLOOD LOSS/BLEEDING ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM GENERAL_POST-PROCEDURAL COMPLICATION STENT.

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 19095831 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE PATIENT EXPERIENCED A HEMORRHAGIC TRANSFORMATION. HEAD COMPUTER TOMOGRAPHY (CT) WITHOUT CONTRAST WAS CLINICALLY SIGNIFICANT ON (B)(6) 2024. THE PATIENT DID NOT RECOVER/RESOLVE. TRACTION BLEEDING COULD NOT BE RULED OUT. A FEW HIGH-DENSITY LESIONS IN THE LEFT MIDDLE CEREBRAL ARTERY SUPPLY AREA ARE PARTIALLY INCREASED AND PARTLY DECREASED. SOME CONTRAST EXUDATION AND PARTIAL HEMORRHAGE ARE CONSIDERED. PATIENT DETAILS: MRS SCORE 0, NIHSS SCORE AVAILABLE: 19. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE PROCEDURE. HEMORRHAGE POST PROCEDURE COMPLICATION MINOR INJURY/ ILLNESS / IMPAIRMENT NO PROBLEM DETECTED DEVICE NOT RETURNED NO FINDINGS AVAILABLE HEMORRHAGE/BLOOD LOSS/BLEEDING ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM GENERAL_POST-PROCEDURAL COMPLICATION STENT

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 19095817 ↗
• DeathApr 11, 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 A INTRACEREBRAL HEMORRHAGE. CRANIAL CT EXAMINATION SHOWED INTRACEREBRAL HEMORRHAGE IN THE LEFT BASAL GANGLIA AND FRONTOPARIETAL LOBE, AND HEMORRHAGIC TRANSFORMATION OF PH2 AFTER THE STROKE TYPE. NIHSS SCORE AVAILABLE: 10, MRS: SCORE: 0. ACTIONS TAKEN: BESIDES, ALBUMIN, CONCENTRATED SODIUM AND FUROSEMIDE DEHYDRATION WERE USED TO REDUCE CRANIAL PRESSURE, BLOOD PRESSURE WAS CONTROLLED BELOW 120 MMHG, SEDATION AND ANALGESIA, AND PREVENTIVE ANTI-SEIZURE. THE EVENT IS NOT RESOLVED. THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE. THE EVENT WAS LIFE THREATENING. PRE-PROCEDURE MTICI SCORE: 0 FINAL POST-PROCEDURE MTICI SCORE: 3.

  Patient problems: Embolism/Embolus; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 19085651 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED CLINICALLY SIGNIFICANT SPASM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). ON (B)(6) 2024 THE PATIENT DEVELOPED VASOSPASM DURING DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THIS ADVERSE EVENT (AE) WAS NOT RELATED TO THE DISEASE UNDER STUDY OR UNDERLYING CONDITION.  AE DID NOT RESULT FROM A DEVICE DEFICIENCY. THE PATIENT'S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE 0, BASELINE /NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 4. THE RIGHT INTERNAL CAROTID ARTERY WAS SLOWLY ADMINISTERED 2ML OF PAPAVERINE INJECTION. THE PATIENT RECOVERED AND THE ISSUE RESOLVED ON (B)(6) 2024. THE SITE ASSESSED THIS EVENT AS NOT LEADING TO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS CAUSALLY RELATED TO THE STUDY PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 18841327 ↗
• MalfunctionNov 1, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THROMBECTOMY FROM THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE MICROGUIDEWIRE AND MICROCATHETER WERE COAXIALLY BROUGHT INTO THE DISTAL ACCESS CATHETER TO THE PROXIMAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY THROMBOSIS. DUE TO THE TORTUOUS NATURE OF THE BLOOD VESSELS, MANY ATTEMPTS WERE MADE DURING PUSHING THE MICROCATHETER ECHELON TO GO UPPER PROCESS. AFTER THE MICROCATHETER WAS IN PLACE, THE STENT WAS READY TO BE PLACED, BUT THE PUSHING RESISTANCE WAS LARGE.  WHEN 2/3 WAS PUSHED IN, THE PUSH ROD OF THE STENT BROKE AND WAS THEN WITHDRAWN. REPLACED WITH ANOTHER STENT OF THE SAME MODEL AND THE RECANALIZATION,  SURGERY WAS COMPLETED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047619 ↗