Surpass Evolve FDS50015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327386691), received between Jun 22, 2021 and Feb 9, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2024Adverse 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 IN A PATIENT SUCCESSFULLY ON (B)(6) 2022. POST PROCEDURE ON (B)(6) 2023, PATIENT STATS THAT SHE LAST REMEMBERS SPEAKING WITH HER FRIEND THAT AFTERNOON AND HAS NO RECOLLECTION OF EVENTS THEREAFTER. PATIENT HERSELF COULD NOT PROVIDE MUCH HISTORY. AS PER FAMILY, PATIENT WAS LAST WELL KNOWN AT 5:20 PM THAT DAY. PATIENT TOOK A NAP AND WHEN WOKE UP PATIENT HAD LEFT-SIDED FACIAL DROOP AND INABILITY TO MOVE LEFT SIDE OF THE BODY. A CT (COMPUTERIZED TOMOGRAPHY) WAS PERFORMED ON (B)(6) 2023. RESULTS INDICATE 'NO NEW ANEURYSM OR ARTERIOVENOUS MALFORMATION IS IDENTIFIED. THE DURAL VENOUS SINUSES AND DEEP VENOUS SYSTEM ARE PATENT', NO STENOSIS WAS OBSERVED, THE SUBJECT STENT IMPLANTED WAS PATENT. PATIENT WAS PROVIDED WITH DIPHENHYDRAMINE, METOCLOPRAMIDE, ACETAMINOPHEN, RIBOFLAVIN MAGNESIUM FOR FOCAL IPSILATERAL HEADACHE. THE AE (ADVERSE EVENT) OUTCOME IS INDICATED RECOVERED/RESOLVED. THE AE WAS REPORTED TO BE RESOLVED ON (B)(6) 2023. THE AE WAS INDICATED AS POSSIBLY RELATED TO STUDY PROCEDURE, STUDY DEVICE, DAPT (DUAL ANTIPLATELET THERAPY) AND UNDERLYING CONDITION OR DISEASE. PATIENT HAS MEDICAL HISTORY OF HYPERTENSION, DYSLIPIDEMIA,

  Patient problems: Headache; Memory Loss/Impairment; Paresis

  MAUDE report 18677793 ↗
• MalfunctionJan 29, 2024Deformation Due to Compressive Stress; Insufficient Device Problem Information; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  IT WAS REPORTED THAT THREE DAYS POST PROCEDURE WITH THE SUBJECT FLOW DIVERTER THE PATIENT WAS RE-ADMITTED TO HOSPITAL WITH COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THREE DAYS POST PROCEDURE WITH THE SUBJECT FLOW DIVERTER, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH HEADACHE AND NAUSEA COMPLICATIONS. PROXIMAL END OF THE SUBJECT STENT WAS FOUND TO BE CHANGED ON COMPUTED TOMOGRAPHY (CT) SCAN AND ANGIOGRAPHY WHICH WAS PERFORMED ON RE-ADMISSION. THE PATIENT CONDITION IS DETAILED AS FINE.

  Patient problems: Headache; Insufficient Information; Nausea

  MAUDE report 18595680 ↗
• MalfunctionOct 20, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROXIMAL END OF THE STENT (SUBJECT DEVICE) FAILED TO FULLY EXPAND AND PARTIALLY DEPLOYED INSIDE THE PATIENT¿S ANATOMY, IT WAS RECAPTURED/REMOVED FROM THE PATIENT¿S ANATOMY. 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 15636982 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SUBJECT FLOW DIVERTER STENT WAS SUCCESSFULLY IMPLANTED FOR A INTERNAL CAROTID ARTERY ANEURYSM IN A PATIENT. DURING 6 MONTH FOLLOW UP, 25-50% VESSEL NARROWING WITH DISTAL STENT FISH MOUTHING WAS OBSERVED. THE PHYSICIAN WAS CONCERNED WITH THE ANGLED POSITION OF THE SUBJECT STENT WITHIN THE VESSEL. THE PATIENT WAS ASYMPTOMATIC THOUGH WAS HAVING NEW HEADACHES THAT STILL ARE LIKELY NOT RELATED. THE PATIENT WAS CONTINUED ON PLAVIX AND ASPIRIN FOR 6 MORE MONTHS. ON (B)(6) 2022 BALLOON ANGIOPLASTY WITH ANOTHER STENT PLACEMENT WAS PERFORMED TO FURTHER ASSIST WITH THE SUBJECT STENT REMAINING OPEN . THE DEVICE WAS MUCH MORE OPEN POST PLASTY, THE STENOSIS WAS MUCH LESS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache; Stenosis

  MAUDE report 15636443 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE PROCEDURE THE PATIENT SUFFERED A STROKE WITH UNKNOWN RELATION TO THE STENT (SUBJECT DEVICE). THE PATIENT WAS PLACED ON A VENTILATOR AND HAD A NIH SCORE OF 18 AFTER THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 12366355 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE OF SUBJECT FLOW DIVERTING STENT DEPLOYMENT IN INTERNAL CAROTID ARTERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2021. IT WAS REPORTED THAT 12- 24 HOURS POST PROCEDURE, PATIENT HAD STROKE DUE TO CLOTTING AROUND THE SUBJECT FLOW DIVERTING STENT. ADDITIONAL SURGERY WAS PERFORMED TO TREAT THE STROKE. THE SUBJECT STENT REMAINS INSIDE THE PATIENT¿S INTERNAL CAROTID ARTERY. NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 12043155 ↗