Surpass Evolve FDS40020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327375206), received between Sep 16, 2021 and Aug 30, 2024 — classified as 10 injuries, 2 malfunctions.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2024Adverse 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 SUBJECT STENT IMPLANTATION PROCEDURE AT THE INTERNAL CAROTID ARTERY-COMMUNICATING (C7 SEGMENT), DURING A FOLLOW UP, THE PATIENT REPORTED TO HAVE "VISION SPELLS" AND A HEADACHE. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND NO NEW ANEURYSMS WERE FOUND, RELATIVELY DECREASED FLOW IN RIGHT MCA AS COMPARED TO PREVIOUS SCANS. THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY THROUGH RIGHT RADIAL ARTERY. NO ADDITIONAL TREATMENT WAS ADMINISTERED DUE TO THIS EVENT, BUT THE PATIENT WAS ADVISED TO RESUME THE INITIALLY PRESCRIBED TREATMENT AS SHE HAS STOPPED.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 20112775 ↗
• InjuryMar 15, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A CAROTID OPHTHALMIC ANEURYSM CASE, SUBJECT FLOW DIVERTER STENT DID NOT OPEN COMPLETELY AT THE TARGET LOCATION RESULTING IN AN HOURGLASS SHAPE FOLLOWING DEPLOYMENT. THEREFORE, AN ATTEMPT WAS MADE TO CROSS THE NARROWING WITH A BALLOON BUT IT FAILED LEADING TO THROMBOSIS, STROKE, AND HEMIPARESIS IN THE PATIENT. THE MANUFACTURER HAS REQUESTED PATIENT STATUS; HOWEVER, AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Paresis; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 18913216 ↗
• MalfunctionMay 16, 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 WAS SUCCESSFULLY IMPLANTED IN A PATIENT (IN LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT)) ON (B)(6) 2022. POST PROCEDURE 6 MONTH FOLLOW UP IMAGING PERFORMED ON (B)(6) 2023 IT WAS NOTED THAT THE SUBJECT STENT HAD PROXIMAL FISH MOUTHING WITHOUT ANY PATIENT SEQUALAE OR VESSEL STENOSIS OR FLOW LIMITATION. ADDITIONALLY IT WAS COMMENTED THAT "THE DEVICE IS DIFFERENT ON THIS ANGIOGRAM THAN AFTER TREATMENT, ITS SHAPE HAS CHANGED". THE FISH MOUTHING IS POSSIBLY RELATED TO STUDY PROCEDURE AND STUDY DEVICE. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 11-OCT-2023 REPORTED THAT ON 12 MONTH ANGIOGRAM SOME FLOW LIMITATION IN THE VESSEL WAS NOTED. ACCORDING TO IMR ASSESSMENT THE FLOW LIMITATION IS THE CAUSALITY OF THE 'HEADACHE' IN THE PATIENT. NO MORE DETAILS AVAILABLE.

  Patient problems: Headache; Stenosis

  MAUDE report 16943088 ↗
• 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 FIRST 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 15795530 ↗
• InjuryJul 14, 2022Migration; Migration

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER IMPLANTATION PROCEDURE WAS PERFORMED FOR ANEURYSM OF RIGHT ICA (INTERNAL CAROTID ARTERY) OPHTHALMIC SEGMENT IN A PATIENT WITH TORTUOUS ANATOMY. FLOW DIVERTER WAS CONFIRMED TO BE FULLY DEPLOYED UNDER FLUOROSCOPY DURING THE PROCEDURE. THE SUBJECT STENT DISTAL MIGRATION WAS REPORTED. ONE WEEK AFTER PROCEDURE SUBJECT STENT OCCLUDED PROXIMALLY DUE TO CLOT FORMATION AT ICA AND PATIENT REPORTED TO HAVE STROKE LIKE SYMPTOMS. PHYSICIAN USED A NON-STRYKER CATHETER FOR CLOT ASPIRATION AS A MEDICAL INTERVENTION. PATIENT IS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 15014384 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 8 MONTHS POST IMPLANT OF THE SUBJECT STENT IN THE INTERNAL CAROTID ARTERY, THE PHYSICIAN IS CONCERNED ABOUT THE NON FLOW LIMITING HYPERPLASIA IN THE VESSEL. THERE ARE NO NEUROLOGICAL DEFICIT IN THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hyperplasia

  MAUDE report 14498619 ↗
• InjuryMay 9, 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 TO TREAT ANEURYSM ON (B)(6) 2021. POST PROCEDURE ON THE SAME DAY PATIENT HAD ENCEPHALOPATHY WITH EXPRESSIVE DYSPHASIA AND WAS APPREHENSIVE TO REPEAT MORE COMPLEX SENTENCES. THE ADVERSE EVENT WAS REPORTED TO BE RESOLVED/RECOVERED ON (B)(6) 2021. CTA DIAGNOSTIC TESTS PERFORMED INDICATES MILD LEFT HEMISPHERIC EDEMA AND MILD CONTRAST STAINING. ON (B)(6) 2022, THE IMR (DESIGNATED CEC MEMBER) HAS ASSESSED THAT THE EXPRESSIVE DYSPHASIA WITH APPREHENSION TO REPEAT MORE COMPLEX SENTENCES IN THE PATIENT WAS DUE TO CONTRAST INDUCED ENCEPHALOPATHY AND HAD POSSIBLE RELATION TO THE SUBJECT FLOW DIVERTER, THE PROCEDURE, THE DUAL ANTIPLATELET THERAPY AND OTHER DEVICES USED DURING THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Cerebral Edema; Dysphasia; Encephalitis; Speech Disorder

  MAUDE report 14334552 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEUROVASCULAR FLOW DIVERTER IMPLANTATION WAS PERFORMED FOR ANEURYSMAL TREATMENT  IN A (B)(6) YR. OLD FEMALE PATIENT WITH OTHER RELEVANT HISTORY OF MARFAN'S SYNDROME. DURING INITIAL FLOW DIVERTER IMPLANTATION PROCEDURE THE FULL EXPANSION OF STENT CELL WITH APPOSITION TO VESSEL WALL ACHIEVED AFTER IMPLANTATION AND CONFIRMED UNDER FLUOROSCOPY. THOUGH THE PHYSICIAN DID NOT HAVE ANY COMPLAINTS FROM THE INITIAL STENT PLACEMENT PROCEDURE AND THERE WAS NOT A LOT OF STASIS IN EITHER ANEURYSM BUT THE PHYSICIAN DECIDED TO USE NON STRYKER BALLOON TO POST PROCESS TO ENSURE GOOD SEAL ACROSS  ANEURYSM NECK.  DURING 5 WEEK POST PROCEDURE FOLLOW UP IMAGING STUDIES IT WAS NOTICED THAT THE VESSEL DIAMETER DISTAL TO THE ANEURYSM WHERE THE DISTAL END OF THE SUBJECT FLOW DIVERTER WAS PLACED HAD NARROWED BY APPROXIMATELY 50%. THE PHYSICIAN IS UNCERTAIN IF HER MARFAN SYNDROME CONTRIBUTES TO THE SITUATION. THE PHYSICIAN DID NOT COMMENT ON THE BLOOD FLOW CHANGES DISTAL TO THE NARROWING DUE TO THE REPORTED ISSUE. THERE WAS NO NEUROLOGICAL DEFICIT OR SEQUELAE NOTICED DUE REPORTED ISSUE. NO ADDITIONAL TREATMENT IS CURRENTLY PLANNED. THE PATIENT IS SCHEDULED FOR A ROUTINE 6-MONTH FOLLOW-UP. PATIENT OUTCOME IS O

  Patient problems: Stenosis

  MAUDE report 14108105 ↗
• MalfunctionMar 11, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT DEPLOYED HALF IN CATHETER AND HALF IN VESSEL. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13728882 ↗
• InjuryJan 7, 2022Adverse 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 IN A CLINICAL TRIAL PROCEDURE, THE SUBJECT FLOW DIVERTER WAS USED IN THE LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) TO TREAT A SACCULAR ANEURYSM MEASURING 8.72MM. 10 DAYS POST PROCEDURE, THE PATIENT HAD VISUAL DISTURBANCES (BLURRED VISION AND VISION LOSS) IN THE LEFT EYE WHICH WERE TREATED BY ADMINISTERING CLOPIDOGREL. THE EVENT WAS REPORTED AS RECOVERED/RESOLVED. THE EVENT WAS REPORTED AS POSSIBLY RELATED TO THE SUBJECT DEVICE BY THE SITE.

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

  MAUDE report 13198695 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL TRIAL, THE SUBJECT FLOW DIVERTER WAS USED FOR TREATMENT. A BALLOON WAS ALSO USED FOR IN STENT BALLOON ANGIOPLASTY IN A SMALL AREA OF NON-APPOSITION OF THE PROXIMAL END OF THE SUBJECT FLOW DIVERTER. EXCELLENT APPOSITION WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. POST PROCEDURE, THE PATIENT HAD A STROKE THAT PRESENTED AS RIGHT HEMIPARESIS. IMAGING DONE SHOWED DEVELOPMENT OF AN ILL DEFINED ACUTE TO EARLY SUB ACUTE INFARCT CENTERED ALONG THE POSTERIOR LIMB LEFT INTERNAL CAPSULE. PATIENT WAS THEN STARTED ON INTEGRILLIN INFUSION, TAKEN TO ICU AND PHENYLEPHRINE WAS THEN INITIATED. PATIENT WAS IN ICU FOR APPROXIMATELY 5 DAYS. IN THE PHYSICIAN'S OPINION, THE EVENT HAD A CAUSAL RELATIONSHIP TO DUAL ANTIPLATELET THERAPY, SUBJECT DEVICE, OTHER STRYKER DEVICE AND UNDERLYING CONDITION OR DISEASE. EVENT WAS REPORTED AS RECOVERING/RESOLVING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Paresis; Stroke/CVA

  MAUDE report 12669709 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL TRIAL PROCEDURE FOR A LEFT OPHTHALMIC SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY, THE SUBJECT FLOW DIVERTER WAS IMPLANTED SUCCESSFULLY. PRE PROCEDURE IMAGING DID NOT INDICATE ANY ADDITIONAL ABNORMALITIES. PROCEDURE ANGIOGRAM INDICATED 0-25% STENOSIS IN THE PARENT ARTERY AND IN THE SUBJECT FLOW DIVERTER IMPLANTED WHICH HAD NO CLINICAL SIGNIFICANCE TO THE PATIENT. ONE DAY POST PROCEDURE, THE PATIENT EXPERIENCED NON SERIOUS PERSISTENT IPSILATERAL HEADACHES THAT WERE UNRELIEVED BY TYLENOL. PATIENT MEDICATION WAS CHANGED TO FIORICET AND THE HEADACHES RESOLVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache; Stenosis

  MAUDE report 12485706 ↗