Surpass Evolve FDS45012Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327386592), received between Oct 5, 2021 and Dec 12, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SUBJECT FLOW DIVERTER STENT IMPLANTATION AT RIGHT INTERNAL CAROTID ARTERY-COMMUNICATING (C7 SEGMENT), WITH BASELINE PARENT ARTERY STENOSIS 0-25% ON (B)(6) 2021. ON (B)(6) 2023 (2Y FOLLOW-UP), ADVERSE EVENT AE#3 INCOMPLETE OCCLUSION OF TARGET ANEURYSM WAS OBSERVED, BOTH MRS/NIHSS AS 0, PHYSICIAN DECISION TO TREAT SAME TARGET ANEURYSM WITH 1 PED. AE OUTCOME - RECOVERING/RESOLVING. THIS AE IS NOT RELATED TO THE STUDY PROCEDURE, OTHER STRYKER DEVICES, PROBABLY RELATED TO STUDY DEVICE, UNLIKELY RELATED TO DAPT AND POSSIBLY RELATED TO DISEASE UNDER STUDY. NO MORE DETAIL AVAILABLE AS NOW.

  Patient problems: Aneurysm

  MAUDE report 18312239 ↗
• InjurySep 22, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT (SUBJECT DEVICE) WAS PLACED INSIDE OF AN ICA VESSEL. UPON FULL DEPLOYMENT, THE MID SECTION OF THE STENT (SUBJECT DEVICE) FAILED TO OPEN FULLY AND APPOSE TO THE VESSEL WALL. A SECOND STENT WAS DEPLOYED TO ADEQUATELY OPEN THE VESSEL WALL. ADDITIONAL MEDICATION WAS ADMINISTERED TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. SIX MONTHS POST PROCEDURE THE PATIENT SUFFERED STENOSIS AND ANEURYSM OCCLUDED WHICH CAUSED A STROKE AND THE PATIENT REQUIRED A THROMBECTOMY. NO FURTHER INFORMATION IS AVAILABLE. BASED ON ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINT INTAKE CENTRE ON 25 SEP 2023, IT WAS CLARIFIED THAT, SIX MONTHS POST INTRACRANIAL ANEURYSM PROCEDURE, THE PATIENT SUFFERED FROM A STROKE DUE TO THE MID SECTION OF THE STENT (SUBJECT DEVICE) NOT BEING FULLY OPEN AND APPOSED TO THE VESSEL WALL. THERE WAS STENOSIS PRESENT AND THE VESSEL WAS OCCLUDED. DURING THE RESULTING THROMBECTOMY PROCEDURE, A SECOND STENT WAS USED TO ADEQUATELY OPEN THE STENT (SUBJECT DEVICE). ADDITIONAL MEDICATION TREATMENT WAS ADMINISTERED. THE PATIENT IS RECOVERING AND NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: Obstruction/Occlusion; Stenosis; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 17799451 ↗
• InjuryAug 18, 2023Adverse 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 POST WITH SUBJECT FLOW DIVERTER STENT ON 2 YEARS FOLLOW UP VISIT PATIENT COMPLAINS OF HAVING SEVERAL INTERMITTENT EPISODES OF LEFT EYE LOWER VISUAL FIELD GO "BLACK" AND THEN RESOLVE ABOUT 30 SECONDS SINCE (B)(6) 2022. PLAVIX MEDICATION WAS RESUMED. OPHTHALMOLOGY CONSULT SUBMITTED TO ASSESS EYE, FLOW AND RULE OUT EMBOLI. THE ADVERSE EVENT WAS INDICATED TO BE POSSIBLY RELATED TO THE STUDY DEVICE, DAPT (DUAL ANTIPLATELET THERAPY) AND AN UNDERLYING CONDITION OR DISEASE. THE ADVERSE EVENT OUTCOME IS INDICATED AS NOT RECOVERED/NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 17580364 ↗
• InjuryMay 2, 2023Adverse 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 THE SUBJECT FLOW DIVERTER WAS IMPLANTED SUCCESSFULLY IN A PATIENT ON (B)(6) 2022. POST PROCEDURE PATIENT EXPERIENCED INTENSE MIGRAINE WITH PRESSURE BEHIND EYES AND SOMETIMES MILD FLOATERS, 1-2 TIMES A WEEK SINCE (B)(6) 2022. MIGRAINES REDUCED IN FREQUENCY OVER TIME. AT 6 MONTH FOLLOW-UP, PATIENT HAD NOT HAD A MIGRAINE IN 3 WEEKS. ACETAMINOPHEN 250MG ORAL AS NEEDED WAS PRESCRIBED FOR MIGRAINES. IT WAS REPORTED THAT THE AE OUTCOME FOR MIGRAINES WAS RECOVERED/ RESOLVED ON (B)(6) 2023. MIGRAINE WAS PROBABLY RELATED TO THE STUDY PROCEDURE AND STUDY DEVICE. MIGRAINE WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY AND TO AN UNDERLYING CONDITION OR DISEASE. THE PATIENT EXPERIENCED 4-6 EPISODES OF 'INTERMITTENT SHORT TERM MEMORY LOSS' (SHORT TERM MEMORY LOSS) SINCE (B)(6) 2022 UP TO 6 MONTH FOLLOW-UP, WHERE THE PATIENT CANNOT REMEMBER WHAT THE PATIENT DID THE DAY BEFORE, OR A TASK THAT THEY COMPLETED 20 MINS PRIOR. IT WAS ASSESSED THAT THE 'INTERMITTENT SHORT TERM MEMORY LOSS' WAS POSSIBLY RELATED TO THE STUDY PROCEDURE, STUDY DEVICE, THE DISEASE UNDER STUDY AND TO AN UNDERLYING CONDITION OR DISEASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Pain; Headache; Memory Loss/Impairment; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857217 ↗
• InjuryMay 18, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT (SUBJECT DEVICE) DID NOT OPEN ON THE PROXIMAL END AFTER DEPLOYMENT. THE PHYSICIAN USED SNARE DEVICES TO RETRIEVE THE SUBJECT STENT OUT OF THE PATIENT'S ANATOMY. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO SNARE THE DEVICE AND MOVE IT PROXIMALLY TO A LESS CONCERNING LOCATION IN THE VASCULATURE. THE SUBJECT STENT COULDN'T BE RETRIEVED ENTIRELY FROM THE PATIENT'S VASCULATURES AS IT GOT STUCK IN A TURN. A STENT WAS DEPLOYED ACROSS THE UNOPENED SUBJECT STENT TO PREVENT IT FROM FREE-FLOATING IN THE PATIENT'S ANATOMY AND PUSH IT TO THE LESS CONCERNING LOCATION IN THE VASCULATURE. ADDITIONAL MEDICATION WAS ADMINISTERED TO THE PATIENT DUE TO THIS EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14432834 ↗
• InjuryApr 29, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING FLOW DIVERTER IMPLANTATION PROCEDURE IN A PATIENT WITH POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE PROXIMAL END OF THE SUBJECT FLOW DIVERTER STENT DID NOT OPEN COMPLETELY AND IT NARROWED LIKE A CONE. THE PHYSICIAN TRIED TO ANGIOPLASTY THE PROXIMAL END OF THE STENT OPEN WITH A BALLOON BUT THAT DIDN¿T WORK. HENCE, THE PHYSICIAN PUT ANOTHER STENT ON TOP OF THE SUBJECT DEVICE TO MAKE THE PROXIMAL END APPOSE THE VESSEL WALL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250862 ↗
• 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 12580045 ↗