Surpass Evolve FDS40030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327375220), received between May 11, 2022 and May 17, 2023 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Premature Activation” (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 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.

• DeathMay 17, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING A NEUROVASCULAR PROCEDURE THE SUBJECT FLOW DIVERTER STENT WAS IMPLANTED SUCCESSFULLY IN A PATIENT. FULL EXPANSION OF SUBJECT STENT CELL WITH APPOSITION TO VESSEL WALL ACHIEVED AFTER IMPLANTATION AND CONFIRMED UNDER FLUOROSCOPY AND THE PROCEDURE WAS COMPLETED. EVERYTHING SEEMED FINE WITH POST PROCEDURE IMAGING. WHEN PATIENT WAS EXTUBATED AND MOVED FROM THE TABLE TO THE BED, VITALS DECLINED AND THE PATIENT HAD A CARDIAC ARREST, FOR WHICH THE PATIENT WAS GIVEN CRP (CARDIOPULMONARY RESUSCITATION). THE PATIENT IS DECEASED. ACCORDING TO THE PHYSICIAN THE ADVERSE EVENT WAS NOT RELATED TO THE FLOW DIVERTER. IT WAS NOTED THAT THE SUBJECT FLOW DIVERTER PERFORMED AS INTENDED AND THE PATIENT'S PROXIMAL VASCULAR ANATOMY WAS VERY TORTUOUS. IT IS INCONCLUSIVE OF WHAT WAS THE CAUSE OF THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 17-MAY-2023 CONFIRMED THAT, THE SUBJECT FLOW DIVERTER PERFORMED AS INTENDED. THE CARDIAC ARREST AND PATIENT DEATH WERE NOT RELATED TO THE SUBJECT FLOW DIVERTER STENT. THE PRIMARY CAUSE OF DEATH WAS NOT DISCLOSED.

  Patient problems: Heart Failure/Congestive Heart Failure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943900 ↗
• MalfunctionMay 11, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE AT ICA (INTERNAL CAROTID ARTERY), THE STENT (SUBJECT DEVICE) CAME OFF THE RE-SHEATH PAD DURING DEPLOYMENT. THERE WERE TEN MINUTES SURGICAL DELAY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366711 ↗