Surpass Evolve FDS50040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327375329), received between Oct 10, 2020 and Jul 21, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ENDOVASCULAR PROCEDURE THE SUBJECT FLOW DIVERTING STENT HAD TO BE LOADED AND UNLOADED TO GET THE PERFECT VESSEL WAS APPOSITION. PHYSICIAN USED A J - WIRE TO HELP MASSAGE THE SUBJECT FLOW DIVERTING STENT SO THAT IT CAN POP OFF THE PAD. 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 17371245 ↗
• MalfunctionJul 18, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED DURING THE PROCEDURE WHILE MANIPULATING THE SUBJECT STENT FOR TREATMENT SITE PLACEMENT, IT WOULD NOT RE-CAPTURE INTO THE CATHETER. THE PHYSICIAN REMOVED THE CATHETER AND THE SUBJECT STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347346 ↗
• MalfunctionSep 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN DEPLOYING THE SUBJECT FLOW DIVERTER, BUT THE STENT WAS PLACED IN THE TARGET SITE SUCCESSFULLY. DURING RE-CROSSING RESISTANCE WAS ENCOUNTERED WHEN TRACKING THE CATHETER BACK OVER THE DELIVERY WIRE. UPON REMOVAL, THE RESHEATH PAD WAS FOUND IN THE DISTAL PETAL. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437338 ↗
• MalfunctionJan 5, 2021Difficult to Remove; Difficult or Delayed Activation; Difficult to Remove; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN FACED RESISTANCE WHILE ADVANCING THE SUBJECT FLOW DIVERTING STENT THROUGH THE MICRO CATHETER AND FACED DIFFICULTY TO RE CAPTURE THE SUBJECT STENT INTO THE MICRO CATHETER AFTER PARTIAL DEPLOYMENT. 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 11118605 ↗
• InjuryOct 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED ACUTE CENTRAL RETINAL ARTERY THROMBOSIS APPROXIMATELY 32 HOURS POST DEPLOYMENT OF THE SUBJECT FLOW DIVERTER. THE PATIENT EXPERIENCED ACUTE LOSS OF VISION IN IPSILATERAL EYE OF IMPLANTATION. THE SUBJECT FLOW DIVERTER WAS IMPLANTED IN THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) AND NO DIFFICULTIES WERE ENCOUNTERED DURING THE PROCEDURE. PATIENT RECEIVED 6MG OF IA TPA IN CAROTID AND EXTERNAL ARTERY AS A MEDICAL INTERVENTION TO TREAT THE THROMBOSIS AND LOSS OF VISION. THE VISION IMPROVED AFTER THE PATENT RECEIVED THE MEDICATION. 16 HOURS POST TPA PATIENT¿S SCAN SHOWED MANY MICROHEMORRHAGES AND MEDICAL MANAGEMENT WAS USED TO FOLLOWING INDICATION OF HEMORRHAGES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus; Visual Impairment

  MAUDE report 10659909 ↗