Surpass Evolve FDS45015Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327375244), received between Oct 5, 2021 and Mar 14, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Activation Failure” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025Deformation Due to Compressive Stress; Activation Failure; Deformation Due to Compressive Stress; Activation Failure

  IT WAS REPORTED THAT DURING PROCEDURE THERE WAS A SMALL LEDGE ON THE SUBJECT STENT AND THE ANATOMY WAS ABNORMAL, SO BALLOON USED TO CONFIRM FULL APPOSITION OF THE SUBJECT FLOW DIVERTER STENT. THEN DURING 6 MONTH FOLLOW UP, THE SUBJECT STENT WAS FISH MOUTHED OR TAPERED AT THE END. PATIENT IS PLANNED FOR BALLOON ANGIOPLASTY ON (B)(6) 2025. THERE IS NO OTHER CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610659 ↗
• InjuryMay 24, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PROXIMAL OF THE SUBJECT FLOW DIVERTER DID NOT OPEN AFTER DEPLOYMENT. THE PHYSICIAN ATTEMPTED TO ACCESS THE SUBJECT FLOW DIVERTER TO FULLY OPEN IT BUT WAS UNSUCCESSFUL AND THE SURGERY WAS STOPPED. THE FOLLOWING DAY, ANOTHER SURGERY WAS PERFORMED IN ATTEMPT TO FULLY OPEN THE SUBJECT FLOW DIVERTER BUT WAS UNSUCCESSFUL TO FULLY OPEN PROXIMALLY. THE PATIENT WAS PLACED ON MEDICATION AND IS CURRENTLY HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391669 ↗
• InjuryMar 29, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER WAS SUCCESSFULLY IMPLANTED IN A PATIENT TO TREAT SACCULAR ANEURYSM IN RIGHT ICA-CLINOID (C5 SEGMENT) IN A PATIENT ON (B)(6) 2022. 18 MONTHS POST PROCEDURE ON (B)(6) 2023 DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) SHOWED FISHMOUTH DEFORMITY AT DISTAL STENT MARGIN RESULTING IN MEDICAL MANAGEMENT AND BALLOON ANGIOPLASTY RETREATMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY) ON 21-JUN-2023. IT IS REPORTED THAT THE ADVERSE EVENT (AE) IS PROBABLY RELATED TO THE STUDY PROCEDURE AND THE STUDY DEVICE. THE RATIONALE FOR RELATIONSHIP TO STUDY DEVICE IS INDICATED AS " ASSOCIATED WITH DISTAL MARGIN OF STENT. CHANGE IN STENT CONTOUR BETWEEN TREATMENT AND FOLLOW UP". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008789 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FLOW DIVERTER STENT WAS SUCCESSFULLY IMPLANTED IN A PATIENT ON (B)(6) 2022 TO TREAT ANEURYSM AT LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT), SACCULAR. 6 MONTH FOLLOW UP ON 4/4/2023 SHOWED >75-100% PARENT ARTERY STENOSIS & STENOSIS WITHIN SUBJECT FLOW DIVERTER STENT. NO RELEVANT ADVERSE EVENT WAS REPORTED. PATIENT HAS A PAST MEDICAL HISTORY OF SEVERE HEADACHE/MIGRAINE, ARTERIOVENOUS MALFORMATION. NO MORE DETAIL AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 1-NOV-23 REPORTED THAT THERE WAS SIGNIFICANT INTIMAL HYPERPLASIA PROGRESSING TO OCCLUSION OF THE SUBJECT FLOW DIVERTER. THERE IS NO APPARENT REDUCTION OF BLOOD FLOW TO THE CIRCULATION BEYOND THE OCCLUSION DUE TO ROBUST COLLATERAL CIRCULATION FROM THE ACOM (ANTERIOR COMMUNICATING) AND PCOM (POSTERIOR COMMUNICATING). NO NEW MEDICATIONS OR TREATMENTS ARE PLANNED AS OF NOW.

  Patient problems: Hyperplasia; Stenosis

  MAUDE report 18044733 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROCEDURE WITH THE SUBJECT FLOW DIVERTER STENT ON (B)(6) 2023 PATIENT COMPLAINTS OF RIGHT EYE PAIN ACCOMPANYING MIGRAINE BEHIND RIGHT EYE THE MORNING AFTER DISCHARGE. RIGHT EYE PAIN GOT BETTER WITH TIME AND RESOLVED IN A DAY AND A HALF. THE PATIENT REPORTED THAT IT HAS NOT HAPPENED SINCE. IT WAS INDICATED THAT THE RIGHT EYE PAIN WAS RESOLVED ON (B)(6) 2023. THE ADVERSE EVENT OUTCOME IS INDICATED AS RECOVERED/RESOLVED WITH NO TREATMENT REQUIRED. IT IS INDICATED THAT THE ADVERSE EVENT IS POSSIBLY RELATED TO THE STUDY PROCEDURE, THE STUDY DEVICE, THE DISEASE UNDER STUDY AND TO AN UNDERLYING CONDITION OR DISEASE. THE RATIONALE FOR RELATIONSHIP TO THE STUDY DEVICE INDICATES "POSSIBLE THAT THROMBOSING OF ANEURYSM CAUSED REGIONAL PAIN OR IMPLANT TRIGGERED MIGRAINE". IT WAS REPORTED THAT ON (B)(6) 2023 ABOUT A WEEK AFTER DISCHARGING, PATIENT EXPERIENCED 'PERIPHERAL VISION LOSS' IN HER EYE INTERMITTENTLY LASTING SEVERAL HOURS AND AFTER A FEW DAYS IT SHIFTED TO HER LEFT EYE. LESSENED IN FREQUENCY AND DURATION OVER TIME. IT IS INDICATED THAT THE ADVERSE EVENT WAS NON-SERIOUS AND NO TREATMENT WAS REQUIRED. THE PATIENT ADVERSE EVENT OUTCOME IS INDICATED AS RECOVERING/R

  Patient problems: Headache; Pain; Visual Disturbances

  MAUDE report 17851900 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TEN MONTHS POST PROCEDURE ON (B)(6) 2023 INTIMAL HYPERPLASIA, IN-STENT STENOSIS WITH FLOW DELAY IN THE RIGHT MCA WAS NOTED WITH THE SUBJECT FLOW DIVERTER STENT IMPLANTED TO TREAT SUPRACLINOID RIGHT ICA ANEURYSM. DSA DIAGNOSTIC (INTERVENTIONAL) PROCEDURE WAS PERFORMED ON (B)(6) 2023. THE IN-STENT STENOSIS WAS TREATED WITH PERCUTANEOUS INTERVENTION WITH ANGIOPLASTY AND AN ADDITIONAL STENT WAS IMPLANTED TO OPEN-UP THE SUBJECT STENT. IT WAS NOTED THAT THERE IS NO OBVIOUS RESIDUAL OF PREVIOUSLY SEEN RIGHT SUPRAGLENOID ANEURYSM. THE INTIMAL HYPERPLASIA, IN-STENT STENOSIS WITH FLOW DELAY IS NOTED TO HAVE A CAUSAL RELATIONSHIP WITH THE STUDY PROCEDURE AND THE STUDY DEVICE. THE RATIONALE FOR RELATIONSHIP TO THE STUDY DEVICE INDICATED IS "MD BELIEVES THE FLOW DIVERTER SHORTENED A LITTLE WHICH CAUSED IT TO END AT THE END OF CAVERNOUS CURVE AND DUE TO THE DEVICE IT RESULTED IN MALPOSITION TO THE VESSEL WALL RESULTING IN THE AREA OF STENOSIS AND FLOW TURBULENCE." THE AE OUTCOME WAS INDICATED AS RESOLVED/RECOVERED.

  Patient problems: Stenosis

  MAUDE report 16513734 ↗
• InjuryJan 20, 2023Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER STENT WAS SUCCESSFULLY IMPLANTED IN A PATIENT ON (B)(6) 2022. POST PROCEDURE ON (B)(6) 2022 DISTAL DEVICE STENTING/ DISTAL DEVICE FISH MOUTHING (DISTAL DEVICE FORESHORTENING AND FISH MOUTHING) WAS NOTED WITH THE SUBJECT FLOW DIVERTER DURING A DIAGNOSTIC (INTERVENTIONAL) PROCEDURE. ADDITIONAL STENT WAS IMPLANTED TO REMEDIATE FISH MOUTHING AND MEDICATION (AGGRASTAT) GIVEN. IT WAS NOTED THAT THERE WAS LESS THAN TWENTY FIVE PERCENT STENOSIS SEEN IN SUBJECT FLOW DIVERTER. THERE WAS NO REDUCTION IN THE BLOOD FLOW TO THE DISTAL CEREBRAL TISSUE DUE TO DISTAL DEVICE FORESHORTENING AND FISH MOUTHING. THERE WERE NO NEUROLOGICAL DEFICIT OR SEQUELAE CLINICAL SEQUELAE NOTICED DUE TO DISTAL DEVICE FORESHORTENING AND FISH MOUTHING AND THE PATIENT REMAINS INTACT. IT IS NOTED THAT THE PATIENT IS RECOVERING FROM DISTAL DEVICE STENTING/ DISTAL DEVICE FISH MOUTHING. THE DISTAL DEVICE STENTING/ DISTAL DEVICE FISH MOUTHING IS CASUALLY RELATED TO THE STUDY PROCEDURE, THE STUDY DEVICE (SUBJECT FLOW DIVERTER) AND POSSIBLY RELATED TO RELATED TO THE DISEASE UNDER STUDY.

  Patient problems: Stenosis

  MAUDE report 16212834 ↗
• InjuryJul 12, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT POST-PROCEDURE, THE PATIENT SUFFERED AN ISCHEMIC STROKE DUE TO THE SUBJECT STENT WAS NOT OPENED ON THE PROXIMAL END. THE PHYSICIAN WAS UNABLE TO RE-ACCESS THE SUBJECT FLOW DIVERTER TO OPEN THE PROXIMAL PART. THE PATIENT'S ANATOMY WAS REPORTED TO BE MODERATELY TORTUOUS AND HAD A SHORT TIGHT LANDING ZONE. THE PATIENT CURRENT CONDITION WAS UNKNOWN AND NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 14994244 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE CLINICAL STUDY THAT 16 DAYS POST SUCCESSFUL PROCEDURE WITH THE SUBJECT FLOW DIVERTER STENT, THE PATIENT EXPERIENCED BILATERAL VISUAL DISTURBANCES. THE VISUAL DISTURBANCES CONSISTED OF BLURRY VISION AND FLASHES OF LIGHT AND WERE ASSOCIATED WITH NON SERIOUS HEADACHES. THE VISUAL DISTURBANCES RESOLVED ON THE SAME DAY AND NON SERIOUS HEADACHES WERE REPORTED TO BE RESOLVING. NO INTERVENTION WAS PERFORMED DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 12-NOV-2021 AND THE REPORTED VISUAL DISTURBANCES WERE ASSESSED BY THE CEC AS NOT RELATED TO THE SUBJECT DEVICE. THEREFORE, THIS EVENT DOES NOT MEET REPORTING CRITERIA ANYMORE.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 12580041 ↗