Surpass Evolve FDS32512Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327385625), received between Jun 9, 2021 and Oct 29, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT INTERNAL CAROTID ARTERY ICA PARA CLINOID ANEURYSM PROCEDURE WAS PERFORMED WITH THE SUBJECT STENT ON (B)(6) 2023. SUBSEQUENT DCA SHOWED INTIMAL HYPERPLASIA, BUT IT WAS STABLE ON AN 18-MONTH DCA SO PLAVIX WAS STOPPED. ASPIRIN 81 WAS MAINTAINED. THEN PATIENT CAME TO ED FOR IPSILATERAL VISUAL DEFICITS AND CTA COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED SUBJECT STENT HAS THROMBOSED COMPLETELY. PATIENT HAS MILD SYMPTOMS, AND NO SUBSEQUENT INTERVENTION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Stenosis; Thrombosis/Thrombus; Visual Disturbances

  MAUDE report 20563613 ↗
• InjuryJul 26, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PATIENT UNDERWENT COIL EMBOLIZATION AND FLOW DIVERSION PROCEDURE USING THE SUBJECT STENT. THE PROCEDURE WAS SUCCESSFUL WITH EXCELLENT WALL APPOSITION BOTH DISTALLY AND PROXIMALLY. EXCELLENT ANTEGRADE FLOW ACROSS THE STENT INTO THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY. POST PROCEDURE THE PATIENT WAS SLOW TO RECOVER FROM ANESTHESIA HOWEVER MOVING ALL EXTREMITIES FOLLOWING COMMANDS, NAME, REPETITION PREVENTION WAS INTACT. SUBSEQUENTLY, THE PATIENT DEVELOPED FINDING DIFFICULTIES AND A FACIAL DROOP IN THE RECOVERY ROOM HENCE A CODE STROKE WAS DECLARED, AND EMERGENCY COMPUTED TOMOGRAPHY HEAD AND COMPUTED TOMOGRAPHY ANGIOGRAM WERE PERFORMED THAT DEMONSTRATED PATENCY AND FLOW THROUGH THE SUBJECT STENT WITH NO EVIDENCE OF LARGE VESSEL OCCLUSION OR ACUTE STROKE CHANGES. HOWEVER, THE PATIENT'S SPEECH DIFFICULTIES PERSISTED HENCE THE DECISION WAS MADE TO TAKE THE PATIENT BACK TO ANGIOGRAPHY FOR FURTHER EVALUATION OF THE ANEURYSM AND STENT/COIL CONSTRUCT. THE LEFT INTERNAL CAROTID ARTERY WAS SELECTIVELY CATHETERIZED WITH THE DIAGNOSTIC CATHETER. INITIAL ANGIOGRAPHY DEMONSTRATED SLOWING OF THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY. NON-SUBTRACTED IMAGINING SHOWED THAT THE P

  Patient problems: Dysphasia; Muscle Weakness/Atrophy; Stenosis; Stroke/CVA

  MAUDE report 17394912 ↗
• InjuryOct 18, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT, AFTER A SUCCESSFUL FLOW DIVERTER STENT IMPLANTATION PROCEDURE, THE PATIENT SUFFERED A STROKE. IT WAS FOUND THAT THE SUBJECT FLOW DIVERTER STENT WAS CLOSED. AN ADDITIONAL PROCEDURE WAS PERFORMED, AND THE PHYSICIAN WAS ABLE TO OPEN THE SUBJECT STENT AND VESSEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 15621148 ↗
• InjuryJul 19, 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 AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A LEFT TEMPORAL STROKE WITH SPEECH ISSUES. THE PHYSICIAN CHANGED THE P2Y12 INHIBITOR FROM BRILENTA TO EFFICIENT. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15059284 ↗
• 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 TO TREAT ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) ON (B)(6) 2021. POST PROCEDURE THE PATIENT STARTED TO EXPERIENCE BLURRY VISION INITIALLY ONLY IN THE RIGHT EYE ON (B)(6) 2021. UPDATED INFORMATION RECEIVED ON 18-APR-2021 INDICATES THAT THIS ISSUE WAS IN BOTH THE EYES. ON (B)(6) 2022, THE IMR (DESIGNATED CEC MEMBER) HAS ASSESSED THE BLURRY VISION CHANGES IN THE PATIENT 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: Blurred Vision; Stenosis; Visual Impairment

  MAUDE report 14316141 ↗
• MalfunctionMay 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE STENT (SUBJECT DEVICE), THE PHYSICIAN ATTEMPTED TO TRACK THE CATHETER BACK OVER THE DELIVERY WIRE WHICH WAS THROUGH THE STENT (SUBJECT DEVICE). AFTER RE-CROSSING THE STENT (SUBJECT DEVICE), THE CATHETER SEEMED TO GET STUCK AT THE RESHEATH PAD. THE PHYSICIAN EXPLAINED HE WAS FEELING THE EXCESSIVE FORCE WHEN TRYING TO TRACK THE CATHETER FURTHER OVER THE DELIVERY WIRE. HE PULLED THE CATHETER BACK AND RETRACTED IT OVER THE RESHEATH PAD. THERE WAS A FORCE AND A RELEASE OF FORCE AS THE CATHETER WENT PAST THE RESHEATH MARKER. AT THIS POINT, HE PULLED OUT THE DELIVERY WIRE. WHEN WE VISUALLY INSPECTED THE DELIVERY WIRE, THE RESHEATH PAD HAD MOVED AND WAS LOCATED AT THE DISTAL TIP OF THE STENT DELIVERY WIRE (SUBJECT DEVICE), JUST PROXIMAL TO THE DISTAL MARKER AND PETALS. 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 14283291 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH POST PROCEDURE, PATIENT CAME WITH STROKE SYMPTOMS AND MRI CONFIRMED MICRO-BLEEDS IN THE BRAIN. PATIENT WAS HOSPITALIZED AND NEEDED MEDICATION TO RETURN TO BASELINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 14037426 ↗
• InjuryJun 9, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6), DURING THE PROCEDURE, THE FLOW DIVERTER (SUBJECT DEVICE) WAS SUCCESSFULLY IMPLANTED INTO THE RIGHT P1 SEGMENT. IT WAS REPORTED THAT A DAY LATER, THE PATIENT HAD STROKE SYMPTOMS. UPON DOING A DIAGNOSTIC, IT WAS NOTICED THAT THE FLOW DIVERTER (SUBJECT DEVICE) HAD DRIFTED ONE TO TWO CENTIMETER AWAY FROM WHERE IT WAS IMPLANTED. ON THE 19TH, A SECOND SURGERY WAS DONE TO CORRECT IT AND SUCCESSFULLY COMPLETED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Ischemia Stroke

  MAUDE report 11970983 ↗