Surpass Evolve FDS45025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327375268), received between Jun 4, 2022 and Nov 8, 2022 — classified as 2 injuries.

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

• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF TREATMENT OF A GIANT OPHTHALMIC ANEURYSM ON (B)(6) 2022 USING STENT (SUBJECT DEVICE), APPROXIMATELY 12 HOURS POST PROCEDURE THE PATIENT WAS BROUGHT BACK TO ANGIO SUITE WITH STROKE SYMPTOMS. THERE WAS NO CLOT TO BE RETRIEVED. IT WAS CONFIRMED TO BE HEM ANEURYSM RUPTURE OF SAME TREATED ANEURYSM. THERE WAS SOME BLEEDING AND SUBARACHNOID HEMORRHAGE. PATIENT WAS AND CONTINUES TO BE ON ASPIRIN AND PLAVIX AS DUAL ANTI PLATELET THERAPY (DAPT) BEFORE AND AFTER THE SURGERY. STENT (SUBJECT DEVICE) WAS REPORTED TO BE PERFORMED AS INTENDED. AN ADDITIONAL DIAGNOSTIC WAS DONE ON 18 OCTOBER. PATIENT WAS KEPT IN THE HOSPITAL FOR AN ADDITIONAL WEEK AND HAD ANOTHER STENT PLACED ON 24 OCTOBER AT SAME LOCATION OF SUBJECT STENT. INDICATION OF USING ANOTHER STENT IS UNKNOWN. PATIENT¿S CURRENT CONDITION IS IMPROVING WITH SOME SLIGHT DEFICITS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm; Stroke/CVA

  MAUDE report 15756666 ↗
• InjuryJun 4, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT 9 MONTHS POST FLOW DIVERTER STENT PLACEMENT PROCEDURE FOR LEFT ICA (INTERNAL COMMUNICATING ARTERY) ANEURYSM, THE SUBJECT DEVICE (STENT) WAS RETRACTED AND WAS NO LONGER IN THE POSITION. THE SUBJECT DEVICE STENT MOVED DISTAL AND PROXIMAL TINES WERE NOT AS OPENED RESULTING SLOWED FLOW THROUGH THE SUBJECT DEVICE AND TO DISTAL VESSELS. THE BALLOON ANGIOPLASTY WITH SCEPTOR AND TACKED DOWN WITH ATLAS STENT AS MEDICAL INTERVENTION. THE PATIENT WAS DISCHARGED AND DOING WELL.

  Patient problems: Stenosis

  MAUDE report 14599323 ↗