Surpass Evolve FDS50030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327375312), received between Apr 20, 2022 and Apr 8, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE THERE WAS ¿FISH MOUTHED¿ ON THE PROXIMAL END OF THE SUBJECT STENT. PATIENTS RIGHT SIDE SHUT DOWN AND NOT DOING GREAT. NO ADDITIONAL INFORMATION AVAILABLE. UPDATE: RECEIVED ADDITIONAL INFORMATION ON 30-APR-2024 STATED THE ANATOMICAL LOCATION OF THE REPORTED ISSUE WAS RIGHT PROXIMAL PETROUS SEGNMENT AND THE PATIENT HAS SOME DEFICIT (VISION). IN THE PHYSICIAN¿S OPINION IT IS CONSIDERED AS A NEUROLOGIC DEFICIT AND THE ADVERSE EVENT IS RELATED TO THE REPORTED ISSUE OF 80% FISH MOUTHING OF PROXIMAL STENT. THERE WAS NO HYPERPLASIA OR THROMBOSIS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Paresis; Visual Impairment

  MAUDE report 19067153 ↗
• MalfunctionJun 3, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING ENDOVASCULAR ANEURYSMAL FLOW DIVERTER PLACEMENT PROCEDURE IN THE INTERNAL CAROTID ARTERY(ICA) , WHILE ADVANCEMENT OF THE FLOW DIVERTER STENT, PHYSICIAN FELT RESISTANCE INSIDE THE MICROCATHETER. EXACT LOCATION WHERE FLOW DIVERTER WAS STUCK WAS UNKNOWN. THE SUBJECT FLOW DIVERTING STENT WAS DEPLOYED PREMATURELY INSIDE THE MICROCATHETER. 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 14598129 ↗
• MalfunctionApr 20, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A PROCEDURE AT CAVERNOUS ICS THE STENT (SUBJECT DEVICE) WAS NOT FULLY DEPLOYED BUT IT WAS OPPOSED DISTALLY AND NOT OPEN PROXIMALLY. THE STENT (SUBJECT DEVICE) WAS REMOVED FROM THE PATIENT SAFELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162441 ↗