Surpass Evolve FDS45040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327375282), received between Oct 5, 2020 and Apr 28, 2023 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Premature Activation; Premature Activation

  IT WAS REPORTED, THAT DURING THE PROCEDURE, THE SUBJECT STENT DEPLOYED PREMATURELY WITHIN THE CATHETER. 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 16834138 ↗
• InjuryAug 30, 2022Adverse 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 IMPLANTED IN THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY ON (B)(6) 2021. NINE MONTHS POST PROCEDURE DURING ROUTINE FOLLOW-UP ANGIOGRAM WAS PERFORMED WHICH REVELED HUNDRED PERCENT STENOSIS OF THE PATIENT'S INTERNAL CAROTID ARTERY AND THE SUBJECT FLOW DIVERTER STENT. THERE WAS NO BLOOD FLOW DISTAL TO THE STENOSIS. IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER STENT PERFORMED AS INTENDED DURING DEPLOYMENT. ACCORDING TO THE PHYSICIAN THE STENOSIS OF THE PARENT VESSEL ARTERY IS DUE TO IN SUBJECT STENT STENOSIS, BUT PATIENT DID HAVE ATHEROSCLEROSIS IN THE PARENT VESSEL ARTERY. IT WAS NOTED THAT THERE WAS PARENT VESSEL STENOSIS PRIOR TO TREATMENT ON THE PROXIMAL END OF THE ANEURYSM. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 15318565 ↗
• MalfunctionDec 14, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHEN THE SUBJECT STENT WAS BEING DEPLOYED DURING THE PROCEDURE, IT BECAME TWISTED IN THE MID PORTION. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12992640 ↗
• InjuryOct 5, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT FLOW DIVERTER WAS RESHEATHED APPROXIMATELY SEVEN TIMES AND THE PATIENT'S INTERNAL CAROTID TERMINUS VESSEL HAD VASOSPASM. THE VESSEL VASOSPASM CONSTRICTED THE SUBJECT FLOW DIVERTER AND PREVENTED IT FROM OPENING WHICH WAS REALIZED AFTER CONTRAST INJECTION. THE PHYSICIAN ADMINISTERED VERAPAMIL AND CARDAPINE TO TREAT THE VASOSPASM WHICH RESOLVED. THEN REMOVED THE DEVICE AND REPLACED IT WITH A SECOND FLOW DIVERTER WHICH HAD A PROXIMAL TWIST/KINK THAT WAS UNABLE TO BE RESOLVED WITH DEPLOYMENT. THE SECOND DEVICE WAS RESHEATHED AND REMOVED FORM THE PATIENT ANATOMY. A THIRD DEVICE WAS USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Vasoconstriction

  MAUDE report 10627894 ↗