Surpass Evolve FDS45017Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327386639), received between Jun 11, 2021 and Apr 30, 2025 — classified as 12 injuries, 2 malfunctions.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A FOLLOW UP AFTER A POST-IMPLANTATION PROCEDURE OF THE SUBJECT FLOW DIVERTER STENT THE PATIENT EXPERIENCED SEVER HEADACHE, STAGGERING, IMBALANCE AND A STROKE. MAGNETIC RESONANCE ANGIOGRAPHY (MRA) WAS PERFORMED DURING WHICH AN ACUTE LACUNAR INFARCT OF THE RIGHT CENTRAL PONS WAS DISCOVERED. THE CURRENT PATIENT'S CONDITION IS RECOVERING/RESOLVING. UPDATE: ADDITIONAL INFORMATION RECEIVED ON 23 MAY 2025 CONFIRMED THAT THE ADVERSE EVENT STROKE IS NOT RELATED TO THE STUDY DEVICE.

  Patient problems: Headache; No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 21940109 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER WAS IMPLANTED IN A PATIENT SUCCESSFULLY WITH NO DEVICE DEFICIENCY ON (B)(6) 2023 TO TREAT SACCULAR ANEURYSM AT LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT). THE PATIENT CALLED ON (B)(6) 2024 TO REPORT 4 DAYS OF REPEAT EPISODES OF LEFT EYE VISION LOSS THAT APPEARS LIKE A BRIGHT WHITE LIGHT THAT IS OBSTRUCTING VISION SINCE (B)(6) 2024. THE PATIENT WAS PUT OFF PLAVIX AFTER 6 MONTH VISIT ON (B)(6) 2024. RE-STARTED PLAVIX (B)(6) 2024. AS OF UPDATE ON (B)(6) 2024 SINCE RE STARTING DAPT, PATIENT HAS HAD 3 EPISODES OF THIS LEFT EYE VISION LOSS IN THE LAST MONTH, WHICH IS IMPROVED FROM 3 A DAY AS COMPARED TO WHEN SHE WAS ONLY ON ASA (ACETYLSALICYLIC ACID). CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) HEAD PERFORMED ON (B)(6) 2024 SHOWS WIDELY PATENT SUBJECT FLOW DIVERTER STENT AND INDICATES NO ACUTE INTRACRANIAL HEMORRHAGE, MASS EFFECT OR ACUTE TERRITORIAL INFRACTION. NO LARGE VESSEL OCCLUSION OR HEMODYNAMICALLY SIGNIFICANT STENOSIS IN THE MAJOR INTRACRANIAL ARTERIES. NO CLEAR EXPLANATION FOR AE (ADVERSE EVENT). EYE EXAM SCHEDULED FOR (B)(6) 2024. THE AE OUTCOME IS INDICATED AS NOT RECOVERED/NOT RESOLVED. IT IS REPORTED THAT THE AE IS PROBABLY

  Patient problems: Blurred Vision

  MAUDE report 19055961 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER WAS SUCCESSFULLY IMPLANTED IN A PATIENT WITH ANEURYSM (4.95X3.04, NECK 3,69) AT RIGHT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) WITH PARENT ARTERY STENOSIS 0-25% ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT REPORTS ADVERSE EVENT AE2 INTERMITTENT HEADACHES WHICH ARE MANAGEABLE WITH OVER THE COUNTER OTC TYLENOL. PATIENT DENIES DIZZINESS, CHANGE IN VISION, N/V, WEAKNESS OR SEIZURES. NO TREATMENT REQUIRED, AE NOT RECOVERED/NOT RESOLVED. THIS ADVERSE EVENT IS POSSIBLY RELATED TO STUDY DEVICE, UNDERLYING CONDITION OR DISEASE AND NOT RELATED TO STUDY PROCEDURE, DAPT, OTHER STRYKER DEVICES, DISEASE UNDER STUDY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache; Obstruction/Occlusion; Stroke/CVA

  MAUDE report 18303256 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE SUBJECT FLOW DIVERTER STENT WAS SUCCESSFULLY IMPLANTED IN THE PATIENT ON (B)(6) 2023. POST PROCEDURE ON (B)(6) 2023 PATIENT EXPERIENCED BLURRED VISION IN THE RIGHT EYE. THE RATIONALE FOR RELATIONSHIP TO THE STUDY DEVICE WAS INDICATED AS: "THE STENT COVERED THE OPHTHALMIC NERVE". IT IS INDICATED THAT THE BLURRED VISION IS POSSIBLY RELATED TO THE STUDY PROCEDURE AND THE STUDY DEVICE. THE ADVERSE EVENT OUTCOME IS INDICATED AS RECOVERING/RESOLVING AND NO TREATMENT WAS PROVIDED TO THE PATIENT FOR THIS ADVERSE EVENT. THE MRS (MODIFIED RANKIN SCORE) & NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE NOTED WAS '0' AT DISCHARGE ON (B)(6) 2023. THE MRS SCORE OF 1, NIHSS SCORE OF 3 SCORE WAS NOTED ON (B)(6) 2023. IT IS NOTED THAT THE PATIENT HAS A PAST MEDICAL HISTORY OF HYPERTENSION, FORMER SMOKER, LOCALIZED HEADACHE, SEVERE HEAD TRAUMA, DEPRESSION/ANXIETY, DIABETES, HEARING LOSS, BUDD-CHIARI SYNDROME, KYPHOSCOLIOSIS, PERIPHERAL VENOUS INSUFFICIENCY AND CRANIOTOMY.

  Patient problems: Visual Disturbances

  MAUDE report 18044839 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROCEDURE WITH THE FLOW DIVERTER IMPLANTATION PROCEDURE ON (B)(6) 2023. PATIENT COMPLAINS OF PAIN AND WEAKNESS IN RIGHT BUTTOCK. UPON EVALUATION, PATIENT IS STABLE, BUT WITH TENDERNESS IN THE AFFECTED AREAS. THERE WERE NO SIGNS OF ISCHEMIA TO THE LIMB. THE SUSPECTED DIAGNOSIS IS SCIATIC NERVE PAIN, ALTHOUGH SOME SYMPTOMS DO NOT FIT THAT DIAGNOSIS. PAIN WAS TREATED WITH UNKNOWN MEDICATIONS AND MRI (MAGNETIC RESONANCE IMAGING) WAS SCHEDULED. SYMPTOMS IMPROVED PRIOR TO MIR AND PATIENT WAS THEN DISCHARGED HOME THE SAME DAY. IT IS INDICATED THAT THE ADVERSE EVENT IS POSSIBLY RELATED TO THE STUDY DEVICE, DAPT (DUAL ANTIPLATELET THERAPY) AND AN UNDERLYING CONDITION OR DISEASE. ADDITIONAL COMMENT PROVIDE INDICATES, "REPORTEDLY EVALUATED FOR ATYPICAL RIGHT LEG AND BUTTOCK PAIN AND WEAKNESS FOLLOWING PRIOR TREATMENT OF LEFT ICA ANEURYSM. NO BRAIN IMAGING TO EVALUATE FOR CEREBRAL ISCHEMIA AS POSSIBLE CAUSE. REPORTEDLY RESOLVED WITHOUT TREATMENT".

  Patient problems: Headache; Pain

  MAUDE report 17557805 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROCEDURE WITH THE FLOW DIVERTER PATIENT CONTINUES TO EXPERIENCE LEFT SIDED RETRO-ORBITAL HEADACHES WITH LEFT EYE BLURRY VISION SINCE (B)(6) 2022. HEADACHES ARE DESCRIBED AS ACHY AND HAVE INCREASED IN FREQUENCY FOR PAST ONE MONTH. UNKNOWN CONCOMITANT OR ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. THE ADVERSE EVENT RESOLVED ON (B)(6) 2022. IT IS INDICATED THAT THE ADVERSE EVENT IS POSSIBLY RELATED TO THE STUDY PROCEDURE, THE STUDY DEVICE AND AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Blurred Vision; Headache

  MAUDE report 17553295 ↗
• InjuryJul 26, 2023Migration; Migration

  IT WAS REPORTED THAT 6 MONTHS POST INTERNAL CAROTID ARTERY (ICA) ANEURYSM EMBOLIZATION PROCEDURE, THE STENT (SUBJECT DEVICE) MIGRATED ON THE DISTAL END. NARROWING OF THE LUMINAL DIAMETER VESSEL WALL LED TO THE TAPERING OF THE FLOW DIVERTER AT THE END. NEOINTIMAL HYPERPLASIA OBSERVED AND THE PERCENTAGE OF STENOSIS WAS 51-75%. THE PATIENT IS ON ANTI-PLATELET MEDICATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 17395862 ↗
• MalfunctionJun 14, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE ICA ANEURYSM PROCEDURE, THE STENT (SUBJECT DEVICE) FAILED TO OPEN IN THE MIDDLE PORTION. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127378 ↗
• MalfunctionJan 9, 2023Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT STENT DEPLOYED PREMATURELY DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121992 ↗
• InjuryOct 18, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT ON (B)(6) 2022 WHEN THE SUBJECT FLOW DIVERTER STENT WAS IMPLANTED IN A PATIENT WITH LEFT INTERNAL CAROTID ARTERY (ICA) PARA-OPHTHALMIC ANEURYSM, THE SUBJECT DEVICE DID NOT APPOSE TO THE VESSEL WALL THROUGH THE MID AND PROXIMAL SEGMENTS. A BALLOON WAS USED TWICE TO DILATATE THE DEVICE FROM DISTAL TO PROXIMAL AFTER WHICH THE SUBJECT DEVICE WAS OPEN AND PATENT. PHYSICIAN HAD CONCERN OF CLOT FORMATION BETWEEN THE DEVICE AND VESSEL WALL ON ANGIOGRAM. PATIENT WAS STARTED ON AN INTEGRILIN DRIP OVERNIGHT. REPEAT ANGIOGRAM ON (B)(6) 2022 SHOWED NO CLOT BUT THE MID SEGMENT OF THE SUBJECT DEVICE WAS STILL NOT APPOSED TO THE VESSEL WALL. PLAVIX, WHICH THE PATIENT WAS TAKING FOR 6 MONTHS, WAS DISCONTINUED AND PATIENT WAS PLACED ON BRILINTA. ASPIRIN WAS CONTINUED. PATIENT DEVELOPED A DEEP VENOUS THROMBOSIS & SUPERFICIAL VENOUS THROMBOSIS POST PROCEDURE. SO THE PHYSICIAN IS TESTING PATIENT FOR HYPERCOAGULABILITY. PATIENT IS DOING WELL AND WAS DISCHARGED FROM HOSPITAL AFTER AN OVERNIGHT STAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629350 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN THE CLINICAL TRIAL THE SUBJECT FLOW DIVERTER WAS IMPLANTED IN A PATIENT FOR ANEURYSM IN LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) ON (B)(6) 2021. POST PROCEDURE THE PATIENT HAD A PREVIOUS VISIT ON (B)(6) 2021 FOR TRANSIENT VISION CHANGES INVOLVING BOTH THE EYES, WHICH RESOLVED ON ITS OWN ON THE SAME DAY. CT AND MRI DIAGNOSTIC TESTS PERFORMED CAME BACK NORMAL AS PER SITE REPORTING. AT THE VISIT PATIENT WAS PRESCRIBED NORCO 5-325 MG FOR FIBROMYALGIA PAIN. ON (B)(6) 2022, THE IMR (DESIGNATED CEC MEMBER) HAS ASSESSED THE TRANSIENT VISION CHANGES IN THE PATIENT HAD POSSIBLE RELATION TO THE SUBJECT FLOW DIVERTER, PROCEDURE AND THE DUAL ANTIPLATELET THERAPY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 14315679 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A SUCCESSFUL PROCEDURE DURING A CLINICAL TRIAL FOR AN ANEURYSM IN THE INTERNAL CAROTID ARTERY-CLINOID (C5 SEGMENT), THE SUBJECT HAD VISUAL DISTURBANCE. THIS WAS DESCRIBED AS INTERMITTENT LEFT EYE FLASHING LIGHTS LIKE A SHOOTING STAR. THE VISUAL DISTURBANCES HAD NO ASSOCIATED SYMPTOMS. ON EYE EXAMINATION, A NORMAL RETINA WITH NO ISSUES WAS FOUND. A DIAGNOSTIC TEST FOR ANTIPLATELET EFFICACY WAS ALSO PERFORMED WHERE THE PRU LEVEL WAS 52. THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. IN THE SITE PHYSICIAN'S OPINION, THIS EVENT WAS NOT RELATED TO THE SUBJECT FLOW DIVERTER AS IT WAS CONTRALATERAL. CEC ADJUDICATED THIS EVENT AS POSSIBLY RELATED TO THE SUBJECT FLOW DIVERTER, LONG SHEATH, CATHETER AND MICRO CATHETER. ADDITIONAL INFORMATION RECEIVED FROM THE SITE ON 05-APR-2022 CONFIRMED THAT THE HEADACHE WAS A NON-SERIOUS IN NATURE AND TYLENOL 650 MG WAS PRESCRIBED PER SITE ENTRY.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 12943679 ↗
• InjuryNov 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING POST PROCESSING WITH SYNCHRO WIRE THE PROXIMAL STENT (SUBJECT DEVICE) MOVED AND OBSTRUCTED FLOW. WHICH CAUSED A SURGICAL DELAY. THE PATIENT WAS DISCHARGED ON BRILINTA AND ASPIRIN. THE PATIENT'S CONDITION IS STABLE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858892 ↗
• InjuryJun 11, 2021Activation Failure; Activation Failure

  A STENT (SUBJECT DEVICE) WAS SUCCESSFULLY DEPLOYED AND IMPLANTED WITHIN THE PATIENT ON (B)(6) 2021. LATER THE SAME EVENING, THE PATIENT WAS FOUND TO HAVE STROKE-LIKE SYMPTOMS AND PRESENTED WITH APHASIA. THE DEVELOPMENT OF STROKE-LIKE SYMPTOMS AND APHASIA WAS REPORTED TO BE RELATED TO THE SUBJECT STENT. A CTA SHOWED THAT THE PROXIMAL END OF THE SUBJECT STENT IMPLANT HAD PARTIALLY CLOSED OFF. IT WAS REPORTED THAT THE PROXIMAL END OF THE SUBJECT STENT LIKELY WAS NOT FULLY OPPOSED TO THE VESSEL WALL WHICH RESULTED IN ITS GRADUAL CLOSING. AFTER ADMINISTERING A MEDICATION (INTEGRILIN) THE PATIENT'S SYMPTOMS HAD RESOLVED AND THE PATIENT WAS TRANSPORTED TO THE INTERVENTIONAL LAB FOR FURTHER EVALUATION. THE SUBJECT STENT WAS DISCOVERED ON ANGIOGRAM TO HAVE OPENED MORE THAN WHAT WAS PRESENTED ON THE CTA, BUT WITH A LEDGE STILL REMAINING. A NEW STENT WAS PLACED WITHIN THE PROXIMAL END OF THE SUBJECT STENT TO ALLOW IT TO OPEN. THE REMAINDER OF THE SUBJECT STENT WAS FULLY INTACT AND WELL OPPOSED. PATIENTS SYMPTOMS RESOLVED AFTER MEDICATION ADMINISTRATION. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Dysphasia; Stroke/CVA

  MAUDE report 11987694 ↗