Surpass Evolve FDS45020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327375251), received between Mar 21, 2022 and Mar 9, 2026 — classified as 1 death, 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT STENT PROCEDURE WAS SUCCESSFULLY COMPLETED ON 22-SEP-2022. POST PROCEDURE ON (B)(6) 2025, PATIENT DEVELOPED AE7 (ACUTE LEFT VISUAL DEFICIT) THAT RESULTED IN CONCOMITANT OR ADDITIONAL TREATMENT GIVEN AND REFERRAL TO OPHTHALMOLOGIST. THE PATIENT RECEIVED DUAL ANTIPLATELET THERAPY DAPT PRIOR TO PROCEDURE IN ACCORDANCE WITH INSTITUTIONAL STANDARD OF CARE AND THE ANTIPLATELET TEST ESTABLISHED EFFECTIVENESS. THIS EVENT WAS POSSIBLY RELATED TO STUDY PROCEDURE AND STUDY DEVICE. IT WAS POSSIBLY DUE TO EMBOLISM FROM STENT THROUGH OPHTHALMIC ARTERY TO INJURE RETINA. THE EVENT IS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thromboembolism; Visual Disturbances

  MAUDE report 24553656 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER PERFORMED AS INTENDED DURING THE PROCEDURE AND IMPLANTATION AT FUSIFORM DISTAL ICA (INTERNAL CAROTID ARTERY) ANEURYSM. DURING A FOLLOW-UP DIAGNOSTIC APPOINTMENT , MAL APPREHENSION (NARROWED AND NOT APPOSED) WAS OBSERVED IN THE SUBJECT'S PROXIMAL STENT. 90% FISH-MOUTHING WAS OBSERVED ON THE PROXIMAL END OF THE SUBJECT STENT DURING THE FOLLOW-UP NOT CAUSED BY HYPERPLASIA OR THROMBOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 20189875 ↗
• 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 STENT WAS SUCCESSFULLY IMPLANTED IN A PATIENT FOR ANEURYSM (4.95X3.04, NECK 3,69) AT LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT), WITH PARENT ARTERY STENOSIS 0-25% ON (B)(6) 2023. ON (B)(6) 2023, PATIENT DEVELOPED ADVERSE EVENT AE# 3 INTERMITTENT HEADACHES WHICH ARE MANAGEABLE WITHOUT MEDICATIONS. NO TREATMENT REQUIRED, EVENT IS NOT RECOVERED/NOT RESOLVED. THIS AE IS POSSIBLY RELATED TO THE STUDY DEVICE, DAPT AND AN UNDERLYING CONDITION OR DISEASE AND NOT RELATED TO OTHER STRYKER DEVICES, DISEASE UNDER STUDY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 18303254 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST PROCEDURE WITH THE SUBJECT FLOW DIVERTER ON (B)(6) 2022 PATIENT DEVELOPED PAIN IN GROIN AND HAD CONTINUED HEADACHES. PATIENT HAS PAST HISTORY OF HEADACHES. THE PAIN IN HEAD AND GROIN CONTINUED TO PERSIST AT 1 MONTH FOLLOW UP VISIT AS WELL. PATIENT HAS A MEDICAL HISTORY OF SEVERE HEADACHE/MIGRAINE, DEPRESSION, ANXIETY AND PAIN. ADVERSE EVENT OUT COME IS INDICATED AS NOT RECOVERED/NOT RESOLVED. IT WAS INDICATED THAT NO TREATMENT WAS REQUIRED. THE ADVERSE EVENT IS INDICATED TO BE POSSIBLY RELATED TO THE STUDY PROCEDURE, THE STUDY DEVICE AND AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Pain

  MAUDE report 17620829 ↗
• InjuryJun 19, 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 A PATIENT ON (B)(6) 2022. POST PROCEDURE PATIENT CALLED THE CLINIC COMPLAINING OF POST OPERATIVE HEADACHES SINCE ON (B)(6) 2022 THAT WERE NOT IMPROVING. PATIENT WAS TAKING TYLENOL AND OXYCODONE SINCE ON (B)(6) 2022. PATIENT SAW A DIFFERENT PROVIDER AND NOTED POST OPERATIVE HEADACHES HAD RESOLVED ON (B)(6) 2022. IT IS INDICATED THAT THE HEADACHE WAS POSSIBLY RELATED TO THE STUDY PROCEDURE, STUDY DEVICE AND AN UNDERLYING CONDITION OR DISEASE. ADDITIONAL COMMENTS PROVIDED STATES "POST-PROCEDURE HEADACHES REQUIRING NARCOTIC MEDICATION". THE OUTCOME OF HEADACHES IS INDICATED AS RECOVERED/ RESOLVED.

  Patient problems: Headache

  MAUDE report 17151958 ↗
• InjuryNov 15, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE INTERNAL CAROTID ARTERY ANEURYSM PROCEDURE, PHYSICIAN TRIED TO DEPLOY THE SUBJECT FLOW DIVERTING STENT. HOWEVER, IT DID NOT OPEN INSIDE THE PATIENT ANATOMY AND WAS RE SHEATHED ONCE AND DEPLOYED. THE SUBJECT FLOW DIVERTING STENT WAS NOT FULLY OPENED FROM THE PROXIMAL END. PHYSICIAN USED A BALLOON TO PERFORM ANGIOPLASTY AND AN ADDITIONAL STENT WAS DEPLOYED AT THE PROXIMAL END TO GET A GOOD VESSEL WALL APPOSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795960 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEUROVASCULAR PROCEDURE WAS PERFORMED IN A PATIENT ON (B)(6) 2022 FOR STENT IMPLANTATION AND 2-STENTS WERE IMPLANTED SUCCESSFULLY WITHOUT ANY DEVICES DEFICIENCIES. POST PROCEDURE ON (B)(6) 2022 THE PATIENT COMPLAINED OF BLURRY VISION AND GROIN DISCOMFORT. IT WAS NOTED THAT THE GROIN IS SOFT AND NO HEMATOMA WAS NOTED. THE PATIENT WAS SENT FOR A DIAGNOSTIC (INTERVENTIONAL) PROCEDURE. THE RESULTS SHOWED IN-STENT THROMBOSIS (ARTERIAL STENT THROMBOSIS), WHICH LED TO THE PROLONGED HOSPITALIZATION, UNKNOWN SURGICAL TREATMENT AND THE PATIENT WAS STARTED ON INTREGRELLIN BOLUS AND DRIP. IT WAS NOTED THAT THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2022 AND THE ARTERIAL STENT THROMBOSIS WAS CAUSALLY RELATED TO THE SECOND SUBJECT FLOW DIVERTER STENT AND THE STUDY PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Discomfort; Eye Pain; Headache; Thrombosis/Thrombus

  MAUDE report 15795655 ↗
• DeathOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST SUCCESSFUL DEPLOYMENT OF THE STENT (SUBJECT DEVICE) SIGNIFICANT CONTRAST EXTRAVASATION WAS VISUALIZED DUE TO VESSEL PERFORATION FROM THE LEAD WIRE OF THE STENT (SUBJECT DEVICE) AT THE LEFT M1/M2 BIFURCATION. EVD PLACED DUE TO SIGNIFICANT AMOUNT OF BLOOD, PROTOMINE WAS GIVEN BY ANESTHESIA TO REVERSE THE HEPARIN THAT WAS GIVEN DURING PROCEDURE AS A MEDICAL INTERVENTION. THIS DID NOT STOP THE BLEEDING, SO PHYSICIAN PLACED A BALLOON AS A MEDICAL INTERVENTION IN THE M1 SEGMENT TO STOP AND PREVENT FUTURE EXTRAVASATION OF BLOOD INTO THE BRAIN, AND SUBSEQUENTLY DECIDED TO COIL SACRIFICE THE ENTIRE M1 SEGMENT. PATIENT IS NOT RESPONDING TO STIMULI. PATIENT RECEIVED A VENTRICULOSTOMY IN THE PROCEDURE ROOM IMMEDIATELY AFTER THE SURGERY. PATIENT ALSO REQUIRED HEMICRANIECTOMY FOR BRAIN SWELLING A FEW DAYS AFTER PROCEDURE. PATIENT PASSED AWAY. THE RELATIONSHIP OF PATIENT DEATH TO THE SUBJECT DEVICE AND THE ASSOCIATED PROCEDURE IS UNKNOWN.

  Patient problems: Extravasation; Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 15629568 ↗
• InjuryMay 20, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT IN THE CLINICAL TRIAL THE SUBJECT FLOW DIVERTER STENT WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY IN A PATIENT ON (B)(6) 2021. DURING THE PROCEDURE A MICROCATHETER WAS USED TO DEPLOY THE SUBJECT FLOW DIVERTER. AFTER DEPLOYMENT FOLLOW-UP ANGIOGRAPHY THROUGH THE GUIDE CATHETER, REVEALED SMALL MALPOSITION OF THE DISTAL AND THE PROXIMAL END OF THE SUBJECT FLOW DIVERTER STENT. BASED ON THESE FINDINGS, A BALLOON WAS GUIDED TO THE TARGET LESION USING A GUIDEWIRE. THE BALLOON WAS INFLATED AND ANGIOPLASTY WAS PERFORMED AT THE DISTAL END OF THE SUBJECT FLOW DIVERTER STENT. A DYNA CT WAS THEN PERFORMED WHICH SHOWED IMPROVE APPOSITION OF THE SUBJECT FLOW DIVERTER STENT TO THE VESSEL WALL. HOWEVER, THERE WAS CONCERN FOR A FILLING DEFECT AT THE DISTAL END OF THE SUBJECT FLOW DIVERTER STENT. FOLLOW-UP ANGIOGRAPHY PERFORMED REVEALED PLATELET AGGREGATION AT THE DISTAL END OF THE SUBJECT FLOW DIVERTER STENT. THE DECISION WAS MADE TO ADMINISTER FURTHER HEPARIN BOLUSES, INTRA-ARTERIAL INTEGRILIN BOLUS, AND THE PATIENT WAS STARTED ON INTEGRILIN DRIP. REPEATED INJECTIONS REVEALED GRADUAL RESOLUTION OF PLATELET AGGREGATION WITH NO CLINICAL SEQUALAE. THERE WAS MINIMAL MALPOSITI

  Patient problems: Headache; Thrombosis/Thrombus

  MAUDE report 14453360 ↗
• MalfunctionMar 21, 2022Fracture; Premature Activation; Fracture; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT FLOW DIVERTER DISTAL DELIVERY WIRE WAS FOUND NOT VISIBLE UNDER FLUOROSCOPY WHILE ADVANCING THE SUBJECT FLOW DIVERTER INSIDE THE MICROCATHETER AND WHILE DEPLOYING THE FLOW DIVERTER INSIDE THE PATIENT ANATOMY. THE PHYSICIAN WAS CONCERNED IT WAS POSSIBLE THAT THE SUBJECT FLOW DIVERTER DISTAL DELIVERY WIRE WAS TUCKED INSIDE THE MICROCATHETER. THE SUBJECT FLOW DIVERTER WAS RE-SHEATHED AND REMOVED FROM THE PATIENT'S ANATOMY. 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 13844090 ↗