Surpass Evolve FDS40025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327375213), received between May 7, 2022 and Feb 10, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2023Adverse 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 RIGHT ICA TO TREAT A PARAOPHTALMIC ANEURYSM IN A PATIENT. THE SUBJECT STENT PLAYED SHORT AND LANDED WITH A LEDGE AND THEREFORE A SECOND STENT WAS TELESCOPED TO LAND WELL IN THE HORIZONTAL CAVERNOUS. UPON SIX MONTH POST PROCEDURE FOLLOW-UP THE DISTAL SEGMENT OF THE SUBJECT STENT (FIRST STENT) SHOWED STENOSIS (DISTAL TO DISTAL END OF SECOND FLOW DIVERTER STENT). NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 16355429 ↗
• 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 FOR TREATMENT OF ANEURYSM IN LEFT INTERNAL CAROTID ARTERY-CAVERNOUS (C4 SEGMENT) ON (B)(6) 2021 WHICH COMPLETELY COVERED THE ANEURYSM NECK. POST PROCEDURE ON (B)(6) 2021 THE PATIENT HAD A MIGRAINE HEADACHE WHERE THE HEADACHE WAS TYPICALLY SLOW IN ONSET ALONG WITH DIZZINESS. IT WAS REPORTED THAT THIS TYPICAL HEADACHE WAS CONSISTENT WITH PRE-TREATMENT MIGRAINE SYMPTOMS IN THE PATIENT. AS PER SITE REPORTING THE PATIENT WAS PRESCRIBED BENADRYL 25MG ONCE IV, REGLAN 5MG ONCE IV, AND HALDOL 2.5MG ONCE IV. THE PATIENT RECOVERED FROM MIGRAINE HEADACHE ON (B)(6) 2021. CT DIAGNOSTIC TESTS PERFORMED CAME BACK NEGATIVE. ON (B)(6) 2022, THE IMR (DESIGNATED CEC MEMBER) HAS ASSESSED THE MIGRAINE HEADACHE IN THE PATIENT HAD POSSIBLE RELATION TO THE SUBJECT FLOW DIVERTER AND AN UNDERLYING CONDITION OR DISEASE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 14319598 ↗