Surpass Evolve FDS40012Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327386516), received between Jul 19, 2021 and Aug 15, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROCEDURE 12 MONTH FOLLOW UP IMAGING ON (B)(6) 2023 SHOWS 75-100 PERCENTAGE STENOSIS WITHIN THE SUBJECT FLOW DIVERTER STENT. PATIENT WAS PUT ON BRILINTA AND ASPIRIN MEDICATION AND PATIENT IS ASYMPTOMATIC. IT IS INDICATED THAT THE 'LEFT HIGH GRADE FLOW LIMITING STENOSIS' IS CAUSALLY RELATED TO THE STUDY PROCEDURE AND THE STUDY DEVICE. THE ADVERSE EVENT IS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE ADVERSE EVENT OUTCOME IS NOT RECOVERED/NOT RESOLVED.

  Patient problems: Stenosis

  MAUDE report 17553213 ↗
• InjuryNov 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER WAS IMPLANTED SUCCESSFULLY IN THE PATIENT IN (B)(6) 2021. POST PROCEDURE IN (B)(6) 2021 IT WAS NOTED THAT THE SUBJECT FLOW DIVERTER HAD FIFTY PERCENT IN-STENT STENOSIS WITH DISTAL FISH-MOUTHING. TWELVE MONTH (APPROXIMATELY SIX MONTHS FROM (B)(6) 2021) ANGIO PERFORMED IT WAS NOTED THAT THE NARROWING/STENOSIS PERSISTED. IN THE PHYSICIAN¿S OPINION, THE STENOSIS WAS NOT RELATED TO THE SUBJECT DEVICE. THE PATIENT WAS AND CONTINUES TO BE ASYMPTOMATIC. THE PHYSICIAN DECIDED TO IMPLANT ANOTHER FLOW DIVERTER IN THE PATIENT IN (B)(6) 2022 TO OPEN THE VESSEL MORE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Stenosis

  MAUDE report 15720908 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL TRIAL THAT, THE PATIENT WAS FOUND WITH INCIDENTAL VASOSPASM DURING PROCEDURE FOR WHICH 100 UG NITROGLYCERINE GIVEN AND VASOSPASM PROMPTLY RESOLVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE CEC (CLINICAL EVENTS COMMITTEE) HAS ASSESSED THE VASOSPASM TO BE CAUSALLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO SUBJECT FLOW DIVERTER STENT (STUDY DEVICE).

  Patient problems: Vasoconstriction

  MAUDE report 15566892 ↗
• InjuryJul 4, 2022Premature Activation; Difficult to Remove; Premature Activation; Difficult to Remove

  IT WAS REPORTED THAT DURING THE OPHTHALMIC ARTERY ANEURYSM PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE RE-SHEATHING THE SUBJECT STENT AND THE SUBJECT STENT DEPLOYED PREMATURELY OF THE RE-SHEATH PAD INSIDE THE PATIENT ANATOMY. THE PHYSICIAN FELT RESISTANCE WHILE RECAPTURING THE SUBJECT STENT INTO THE MICROCATHETER. DUE TO THAT A THROMBUS WAS FORMED SO BRINLINTA WAS ADMINISTERED TO THE PATIENT AS ADDITIONAL MEDICATION. PHYSICIAN DEPLOYED ANOTHER STENT TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14904376 ↗
• MalfunctionJun 6, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE INTERNAL CAROTID ARTERY ANEURYSM PROCEDURE, THE SUBJECT STENT CAME OFF ITS RE-SHEATH PAD AND DEPLOYED PREMATURELY INSIDE THE MICROCATHETER. PHYSICIAN RE-CAPTURED THE SUBJECT STENT USING THE DISTAL ACCESS CATHETER AND REMOVED IT FROM PATIENT' ANATOMY. THE PHYSICIAN REPLACED THE MICROCATHETER AND STENT WITH NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600178 ↗
• MalfunctionJun 1, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A FLOW DIVERTER STENT IMPLANTATION PROCEDURE IN A PATIENT WITH INTERNAL CAROTID ARTERY ANEURYSM, WHEN THE PHYSICIAN ATTEMPTED TO RECAPTURE THE SUBJECT FLOW DIVERTER STENT THE MICROCATHETER WOULD NOT ADVANCE OVER THE SUBJECT STENT THE PHYSICIAN REMOVED THE SUBJECT STENT AND THE MICROCATHETER INTO THE INTERMEDIATE CATHETER AND THEN REMOVED FROM THE PATIENT VASCULATURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE DEVICE. THERE WAS A SURGICAL DELAY OF 5-10 MIN DUE TO THE DEVICE MALFUNCTION. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569768 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE A SMALL PROXIMAL LEDGE WAS LEFT WHERE THE STENT (SUBJECT DEVICE) WASN T OPPOSING WELL WHICH COULD HAVE CONTRIBUTED TO THE DISTAL STENOSIS ON THE EDGE OF THE STENT (SUBJECT DEVICE) THAT THE PHYSICIAN NOTICED AT A 12-MONTH FOLLOW-UP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Stenosis

  MAUDE report 13885347 ↗
• MalfunctionFeb 2, 2022Premature Activation; Premature Activation

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND DISCOVERED THAT THE SUBJECT STENT WAS DEPLOYED PREMATURELY DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423985 ↗
• InjuryJul 19, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, THE PROXIMAL SEGMENT OF THE SUBJECT FLOW DIVERTER WAS UNABLE TO OPEN AFTER DEPLOYMENT. FEMORAL ACCESS WAS USED IN MODERATELY TORTUOUS ANATOMY. THE PHYSICIAN REPORTED NO RESISTANCE DURING DELIVERY OF THE SUBJECT FLOW DIVERTER. ANY SURGICAL DELAY THAT MAY HAVE OCCURRED DURING THE PROCEDURE WAS UNKNOWN. A BALLOON WAS UNABLE TO BE USED TO OPEN THE PROXIMAL SEGMENT OF THE SUBJECT FLOW DIVERTER AS ACCESS TO THE TARGET LOCATION WAS LOST. SLUGGISH FLOW WAS NOTED IN THE PATIENTS VESSEL DUE TO PROXIMAL CLOSING OF THE SUBJECT FLOW DIVERTER. THE PHYSICIAN ADMINISTERED ANTI COAGULANT MEDICATION TO PREVENT/BREAKUP ANY CLOT THAT MAY/MIGHT/OR ALREADY FORMED AS A RESULT OF THE CLOSED SUBJECT FLOW DIVERTER. THE PATIENT WAS REPORTED TO HAVE BEEN TAKEN TO THE INTENSIVE CARE UNIT. NO OTHER INFORMATION IS PRESENT.

  Patient problems: Stenosis

  MAUDE report 12194214 ↗