Surpass Evolve FDS40015Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327375190), received between Dec 9, 2020 and Sep 4, 2024 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL SUBJECT STENT IMPLANTATION PROCEDURE AT THE INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) WAS CARRIED OUT SUCCESSFULLY VIA RIGHT RADIAL ARTERY. DURING FOLLOW UP PATIENT PRESENTS WITH 50-75% PARENT ARTERY STENOSIS WITHIN THE SUBJECT FLOW DIVERTER EVIDENCED ON THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE PATIENT'S CURRENT CONDITION DESCRIBED AS GOOD, BOTH MRS & NIHSS AS 0.

  Patient problems: Stenosis

  MAUDE report 20138538 ↗
• InjuryOct 20, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER STENT WAS IMPLANTED SUCCESSFULLY DURING THE PROCEDURE WITH A MINOR LEDGE DISTALLY. THIRTY MINUTES POST PROCEDURE, THE PATIENT EXPERIENCED WEAKNESS SHOWING MULTIPLE STROKE SYMPTOMS WITH WEAKNESS IN THE LEFT SIDE, FACIAL DROOP AND SLURRED SPEECH PROMPTING A RETURN TO ANGIO SUITE FOR INTERVENTION. IT WAS DISCOVERED THAT THE PROXIMAL END OF THE SUBJECT FLOW DIVERTER HAD COLLAPSED. AN ADDITIONAL SURGERY WAS PERFORMED, WHERE THE PHYSICIAN DEPLOYED AN ADDITIONAL FLOW DIVERTER STENT TO OPEN THE PROXIMAL END OF THE SUBJECT FLOW DIVERTER STENT. PATIENT IS CONTINUING TO EXPERIENCE WEAKNESS AND IS STILL TREATED IN THE INTENSIVE CARE UNIT AT THE HOSPITAL BUT SHOWS NO STROKE ON IMAGING. PATIENT WILL CONTINUE ON DAPT AND INTERGRELIN FOR NOW. ACCORDING TO THE PHYSICIAN THE REPORTED EVENT WAS DUE TO SUBJECT FLOW DIVERTER STENT FAILURE ON THE PROXIMAL END. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Paresis; Speech Disorder; Stroke/CVA

  MAUDE report 15638746 ↗
• MalfunctionOct 3, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE STENT(SUBJECT DEVICE) GOT JAMMED AND DEPLOYED INSIDE THE MICROCATHETER AT PARA OPHTHALMIC INTERNAL CAROTID ARTERY(ICA) LOCATION. 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 15531571 ↗
• MalfunctionMar 14, 2022Difficult to Remove; Difficult to Remove

  BASED ON ADDITIONAL INFORMATION RECEIVED ON 18 FEB 2022, IT WAS REPORTED THAT FRICTION WAS NOTED WHEN THE PHYSICIAN ATTEMPTED TO RE-CAPTURE THE SUBJECT DIVERTING STENT INTO THE MICROCATHETER. THEREFORE, THIS EVENT MEETS THE REQUIREMENTS OF A REPORTABLE EVENT WITH AN AWARENESS DATE OF (B)(6) 2022(VN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13756125 ↗
• MalfunctionJan 26, 2022Difficult or Delayed Activation; Device Dislodged or Dislocated; Difficult or Delayed Activation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE POSTERIOR COMMUNICATING ARTERY ANEURYSM TREATMENT, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN POSITIONING THE SUBJECT FLOW DIVERTER INSIDE THE PATIENT ANATOMY. WHILE DEPLOYING THE SUBJECT FLOW DIVERTER INSIDE THE PATIENT ANATOMY, IT WAS PARTIALLY DEPLOYED AND MOVED AWAY FROM THE LESION WHERE IT WAS DEPLOYED. THE PHYSICIAN RE-SHEATHED THE SUBJECT FLOW DIVERTER AND REMOVED IT FROM THE PATIENT'S ANATOMY. THE PATIENT'S VESSEL TORTUOSITY WAS REPORTED TO BE TORTUOUS . 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 13358283 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL TRIAL PROCEDURE TO TREAT A SACCULAR INTRACRANIAL ANEURYSM MEASURING 9.2MM IN THE LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT), THAT THE PATIENT HAD A HEADACHE AFTER THE PROCEDURE AND INTERMITTENTLY SINCE THE PROCEDURE. THE HEADACHE WAS ACCOMPANIED BY NAUSEA. NO DIAGNOSTIC TESTS, TREATMENT, INTERVENTIONAL PROCEDURES OR HOSPITALIZATIONS WERE PERFORMED IN RESPONSE TO THE HEADACHE. HEADACHE IS REPORTED AS RECOVERING/RESOLVING. ACCORDING TO THE SITE, THE REPORTED EVENT WAS POSSIBLY RELATED TO THE SUBJECT FLOW DIVERTER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Nausea

  MAUDE report 13256813 ↗
• MalfunctionDec 22, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE OF FLOW DIVERSION OF AN ICA ANEURYSM, UPON INITIAL DEPLOYMENT OF THE DEVICE, IT WAS OBSERVED THAT THE STENT HAD FALLEN OFF THE RE-SHEATH PAD PREMATURELY. THE PHYSICIAN RECAPTURED THE ENTIRE STENT WITH THE MICROCATHETER AND REMOVED IT FROM THE PATIENT'S BODY. 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 13065370 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 270 DAYS POST IMPLANT WITH THE SUBJECT FLOW DIVERTER IN A CLINICAL TRIAL PROCEDURE TO TREAT AN UNRUPTURED SACCULAR INTRACRANIAL ANEURYSM MEASURING 4.5MM IN THE RIGHT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT), THE PATIENT HAD IN STENT STENOSIS THAT HAD INCREASED FROM 0-25% POST IMPLANTATION TO 50-75% AT 6 MONTHS FOLLOW UP. DURING THE PROCEDURE, THE SUBJECT FLOW DIVERTER WAS REPORTED TO HAVE BEEN OPENED AND USED SUCCESSFULLY TO COMPLETELY COVER THE ANEURYSM NECK. NO TREATMENT WAS ADMINISTERED FOR THE REPORTED EVENT. THE PATIENT DID NOT EXPERIENCE ANY CLINICAL COMPLICATIONS SINCE THE LAST VISIT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 13056378 ↗
• MalfunctionDec 20, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING PROCEDURE AT INTERNAL CAROTID ARTERY, WHEN THE STENT (SUBJECT DEVICE) WAS PUSHED INTO NEUROVASCULATURE THROUGH MICROCATHETER. UPON INITIAL DEPLOYMENT OF THE DEVICE, IT WAS OBSERVED THAT THE STENT (SUBJECT DEVICE) HAD FALLEN OFF THE RE-SHEATH PAD WITHIN THE MICROCATHETER. THE PHYSICIAN RECAPTURED THE ENTIRE STENT (SUBJECT DEVICE) WITH THE MICROCATHETER AND REMOVED IT FROM THE PATIENT'S BODY. ONE ATTEMPT WAS MADE TO RECAPTURE/RESHEATH THE STENT (SUBJECT DEVICE) BACK INTO MICROCATHETER. THE PHYSICIAN USED NEW STENT AND NEW MICROCATHETER AND CONTINUED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049609 ↗
• MalfunctionNov 24, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A PCOMM ANEURYSM CASE, UPON ATTEMPTING TO DEPLOY AND RE-SHEATH THE STENT (SUBJECT DEVICE) , THE PHYSICIAN LOST THE ABILITY TO RE-SHEATH THE SYSTEM. HE TOOK THE INTERMEDIATE CATHETER ALL THE WAY UP INTO THE M1, BUT THE PHYSICIAN WAS STILL UNABLE TO RE-SHEATH THE STENT (SUBJECT DEVICE). AS THE PHYSICIAN TRIED TO RE-SHEATH, THE STENT (SUBJECT DEVICE) JUMPED FORWARD AND WAS NO LONGER ON THE RE-SHEATH PAD OF THE DELIVERY WIRE. THE STENT (SUBJECT DEVICE) WAS TRAPPED INSIDE THE MICROCATHETER ON THE DELIVERY WIRE, SO THE PHYSICIAN TOOK THE INTERMEDIATE CATHETER UP AND WAS ABLE TO RECAPTURE THE STENT (SUBJECT DEVICE) INSIDE THE INTERMEDIATE CATHETER. AT THIS POINT, THE EVOLVE SYSTEM WAS REMOVED. UPON VISUALLY INSPECTING THE SYSTEM, THE MICROCATHETER LOOKED STRETCHED AND DAMAGED. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872626 ↗
• MalfunctionNov 24, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A PCOMM ANEURYSM CASE, UPON ATTEMPTING TO DEPLOY AND RE-SHEATH THE STENT (SUBJECT DEVICE) , THE PHYSICIAN LOST THE ABILITY TO RE-SHEATH THE SYSTEM. HE TOOK THE INTERMEDIATE CATHETER ALL THE WAY UP INTO THE M1, BUT THE PHYSICIAN WAS STILL UNABLE TO RE-SHEATH THE STENT (SUBJECT DEVICE). AS THE PHYSICIAN TRIED TO RE-SHEATH, THE STENT (SUBJECT DEVICE) JUMPED FORWARD AND WAS NO LONGER ON THE RE-SHEATH PAD OF THE DELIVERY WIRE. THE STENT (SUBJECT DEVICE) WAS TRAPPED INSIDE THE MICROCATHETER ON THE DELIVERY WIRE, SO THE PHYSICIAN TOOK THE INTERMEDIATE CATHETER UP AND WAS ABLE TO RECAPTURE THE STENT (SUBJECT DEVICE) INSIDE THE INTERMEDIATE CATHETER. AT THIS POINT, THE EVOLVE SYSTEM WAS REMOVED. UPON VISUALLY INSPECTING THE SYSTEM, THE MICROCATHETER LOOKED STRETCHED AND DAMAGED. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872625 ↗
• MalfunctionNov 24, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A PCOMM ANEURYSM CASE, THE CUSTOMER TOOK THE MICROCATHETER AND THE STENT (SUBJECT DEVICE) UP INTO THE M1. THE PHYSICIAN WAS UNABLE TO RE-SHEATH THE STENT (SUBJECT DEVICE). HE RELAXED THE ENTIRE SYSTEM, BUT WAS STILL NOT ABLE TO ADVANCE THE MICROCATHETER BY ADVANCING THE MICROCATHETER OR PULLING ON THE DELIVERY WIRE. THE INTERMEDIATE CATHETER WAS LOCATED IN THE ICA (CAVERNOUS SEGMENT), BUT WAS NOT ABLE TO TRACK IT UP FURTHER. AS THE PHYSICIAN ATTEMPTED TO RE-SHEATH, THE STENT (SUBJECT DEVICE) CAME OFF THE RE-SHEATH PAD. THE PHYSICIAN AT THIS POINT REMOVED THE ENTIRE SYSTEM BY LOCKING DOWN THE MICROCATHETER ON THE DELIVERY WIRE AND REMOVED THE SYSTEM. UPON VISUALLY INSPECTING THE SYSTEM AFTER REMOVAL, THE MICROCATHETER LOOKED STRETCHED AND OVALIZED. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872573 ↗
• MalfunctionDec 9, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) DEPLOYED PREMATURELY WHEN THE PHYSICIAN ATTEMPTED TO REPOSITION IT DURING THE PROCEDURE. THE SUBJECT DEVICE WAS IMPLANTED SUCCESSFULLY. 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 10980977 ↗
• MalfunctionDec 9, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) DEPLOYED PREMATURELY WHEN THE PHYSICIAN ATTEMPTED TO REPOSITION IT DURING THE PROCEDURE. THE DEPLOYED SUBJECT DEVICE WAS RECAPTURED USING A MICROCATHETER AND WAS REMOVED SUCCESSFULLY. 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 10980976 ↗