Surpass Evolve FDS32515Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327375152), received between Jan 4, 2021 and Nov 23, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT, DURING A NEUROVASCULAR PROCEDURE, THE SUBJECT FLOW DIVERTER WAS ADVANCED IN THE MICROCATHETER AND DEPLOYED AS USUAL, BUT IT WAS NOTED THAT THE SUBJECT FLOW DIVERTER DID NOT FULLY OPEN. THEREFORE, THE OPERATOR DECIDED TO RECAPTURE AND REMOVE THE SUBJECT FLOW DIVERTER. WHEN AN ATTEMPT WAS MADE TO RECAPTURE THE SUBJECT FLOW DIVERTER, IT WAS DIFFICULT TO RECAPTURE THE SUBJECT FLOW DIVERTER INTO THE MICROCATHETER. THE SUBJECT FLOW DIVERTER ALONG WITH THE MICROCATHETER WERE TAKEN OUT OF THE PATIENT'S BODY. THE SUBJECT SUBJECT FLOW DIVERTER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15855852 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER DEVICE WAS SUCCESSFULLY IMPLANTED FROM PROXIMAL RIGHT MCA (MIDDLE CEREBRAL ARTERY) TO SUPRACLINOID SEGMENT OF RIGHT ICA (INTERNAL CAROTID ARTERY). 19 DAYS POST FLOW DIVERTER STENT PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED STROKE LIKE SYMPTOMS AND WAS ADMITTED TO HOSPITAL FOR EVALUATION. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) AND MAGNETIC RESONANCE ANGIOGRAM (MRA) WERE PERFORMED SHOWING NARROWING OF IMPLANTED DEVICE. PATIENT THEN HAD FOLLOWED UP ANGIOGRAM SHOWING SEVERE STENOSIS OF VESSEL. ORAL STEROIDS AND ADDITIONAL ANTICOAGULATION WERE ADMINISTERED TO THE PATIENT. PER PHYSICIAN¿S OPINION, STROKE, SEVERE STENOSIS OF VESSEL AND DEFORMATION OF IMPLANTED DEVICE WERE CAUSED BY POTENTIAL NICKEL ALLERGY/ALLERGIC REACTION TO SOMETHING IN THE SUBJECT FLOW DIVERTER DEVICE. PATIENT CURRENT CONDITION IS STABLE, BUT CAROTID HAS COMPLETELY SHUT DOWN (ANEURYSM IS GONE, BUT SO IS THE PARENT VESSEL).

  Patient problems: Stenosis; Stroke/CVA

  MAUDE report 14960040 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STENT (SUBJECT DEVICE) WAS IMPLANTED SUCCESSFULLY DURING A PROCEDURE AT PCOM TO OPTHALMIC REGION. THE PATIENT WAS REPORTED TO HAVE MODERATELY TORTUOUS ANATOMY. DURING A TWO DAY FOLLOW UP, IT WAS NOTED THAT THE SUBJECT STENT HAD DISSECTED THE VESSEL AT ICA CAUSING FISTULA. IT WAS ALSO REPORTED THAT THE PATIENT HAD WEAKNESS AND SMALL STROKE. AS PET THE PHYSICIAN, THE ADVERSE EVENTS WERE DUE TO THE PATIENT'S ANATOMY AND THE SUBJECT STENT PERFORMED AS INTENDED DURING THE PROCEDURE. THE PATIENT¿S CURRENT CONDITION IS REPORTED TO BE STABLE AND IS BEING MONITORED WITH FOLLOW UP VISITS. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Fistula; Paresis; Stroke/CVA; Vascular Dissection

  MAUDE report 12329151 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE STENT WAS USED TO COVER THE NECK OF ANEURYSM. HOWEVER, THE NECK OF THE ANEURYSM WASN¿T COVERED COMPLETELY , SO THE PHYSICIAN HAD TO PLACE A SECOND STENT. COMPUTER TOMOGRAPHY (CT) CONFIRMED THE SUBJECT DEVICE LENGTH WAS MEASURED UNDER 6MM INSTEAD OF 15MM. POST PROCEDURE, THE PATIENT HAD A FOCAL LEFT SUPERIOR MCA (MIDDLE CEREBRAL ARTERY) OCCLUSION. THE PHYSICIAN GAVE A BOLUS OF INTEGRILIN AND TRIED ASPIRATING THE CLOT OUT WITH THE CATHETER AND PUMP A COUPLE TIMES AND THEN TRIED A PASS WITH THE STENT RETRIEVER IN COMBINATION WITH THE CATHETER BUT WAS NOT SUCCESSFUL IN OPENING THE LEFT MCA (MIDDLE CEREBRAL ARTERY). THE CLOT CAME OUT ON THE STENT RETRIEVER DEVICE, BUT MCA REMAINED OCCLUDED. BASED ON THE PHYSICIAN¿S OPINION, THE CAUSE OF THE OCCLUSION WAS RELATED TO THE PROCEDURE DURATION DUE TO HAVING TO PLACE TWO STENTS INSTEAD OF ONE AND HAVING TO ANGIOPLASTY POST STENTING. BOTH OF WHICH INCREASED THE PROCEDURE TIME AND THROMBUS FORMING IN THE ICA (INTERNAL CAROTID ARTERY). THE PROCEDURE HAD GONE AS PLANNED WITH A SUBJECT STENT DEVICE IMPLANTED, IT WOULD HAVE BEEN AN HOUR LONG PROCEDURE FROM START TO FINISH. THE PROCEDURE LASTED 5 HOURS LONGER T

  Patient problems: Aphonia; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 11113137 ↗