Surpass Evolve FDS45030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327375275), received between Oct 9, 2020 and Oct 9, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER WAS DEPLOYED ACROSS THE NECK OF THE UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM AND THERE WAS NARROWING AT THE MID-SECTION OF THE SUBJECT DEVICE FOLLOWING DEPLOYMENT. PHYSICIAN DETERMINED THAT THE PATIENT HAD UNDERLYING INTRACRANIAL ATHEROSCLEROTIC DISEASE IN THIS PORTION OF THE INTERNAL CAROTID ARTERY. DURING PROCEDURE, THE PHYSICIAN TRIED TO TREAT THE DEVICE NARROWING USING A BALLOON BUT WAS NOT SUCCESSFUL. PATIENT HAD EMBOLIC SHOWERS AND SOME STROKE LIKE SYMPTOMS, SIX HOURS POST IMPLANTATION OF THE SUBJECT FLOW DIVERTER. UNKNOWN MEDICATION WAS GIVEN TO THE PATIENT. PATIENT CONDITION WAS STABLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Embolism/Embolus; Ischemia Stroke; Stenosis

  MAUDE report 10659866 ↗