Surpass Evolve FDS40017Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327386530), received between Jan 20, 2021 and Aug 12, 2025 — classified as 3 deaths, 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT BEGUN HAVING EPISODES OF INCREASED TIREDNESS, FATIGUE, AND WEAKNESS. THE SYMPTOMS WOULD COMPLETELY RESOLVE AT TIMES, HOWEVER, WHEN THEY WOULD RETURN THE PATIENT WOULD BE VERY UNSTABLE ON HER FEET. THE PATIENT FELL 2-3 TIMES DUE TO THIS WEAKNESS AND IMBALANCE.

  Patient problems: Dizziness; Fatigue

  MAUDE report 22790234 ↗
• InjuryJun 4, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PROCEDURE AT LEFT INTERNAL CAROTID ARTERY (ICA) PARAOPHTHALMIC ANEURYSM USING A COMBINATION OF COILS AND A FLOW-DIVERTING STENT. THE PHYSICIAN FIRST GAINED ACCESS INTO THE M1 SEGMENT WITH THE MICROCATHETER, FOLLOWED BY ACCESS INTO THE ANEURYSM USING ANOTHER MICROCATHETER. THE PHYSICIAN INITIALLY POSITIONED BUT DID NOT DEPLOY THE COIL, THEN BEGAN UNSHEATHING THE DISTAL END OF THE SUBJECT STENT IN THE SUPRACLINOID SEGMENT OF THE ICA. HE CONTINUED TO UNSHEATH THE DEVICE AND DEPLOYED THE PROXIMAL END OF THE SUBJECT STENT NEAR THE DISTAL PORTION OF THE ANTERIOR GENU (BEFORE THE TURN). HE THEN DEPLOYED THE INITIAL COIL AND PLACED THREE ADDITIONAL COILS. FOLLOWING THE COILING, THE SECOND MICROCATHETER WAS REMOVED, AND ANGIOGRAPHIC IMAGING WAS PERFORMED. A PROXIMAL FISHMOUTH OR LEDGE WAS OBSERVED ON THE SUBJECT STENT. POST-PROCEDURE, THE PATIENT EXPERIENCED A STROKE IN THE ICU (INTENSIVE CARE UNIT). IMAGING REVEALED THROMBUS ACCUMULATION ON BOTH THE PROXIMAL AND DISTAL ENDS OF THE SUBJECT STENT. THE PHYSICIAN ADVANCED THE CATHETERS AND PERFORMED ONE ASPIRATION PASS. HE THEN TRACKED A WIRE THROUGH THE PROXIMAL STENT INTO THE LUMEN AND INTO THE MIDDLE CEREBRAL A

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 22146550 ↗
• InjuryMay 27, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING TARGET SACCULAR ANEURYSM AT LEFT INTERNAL CAROTID ARTERY-COMMUNICATING PROCEDURE, THE DISTAL END OF THE SUBJECT FLOW DIVERTER STENT DID NOT OPEN COMPLETELY, THIS PERSISTED AFTER ANGIOPLASTY AND SO AN ADDITIONAL STENT WAS PLACED. 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 22091406 ↗
• DeathAug 30, 2024Malposition of Device; Activation Failure; Malposition of Device; Activation Failure

  IT WAS REPORTED THAT DURING FLOW DIVERSION OF LEFT POSTERIOR COMMUNICATING (PCOM) ANEURYSM, THE SUBJECT FLOW DIVERTER HAD A DIFFICULTY OPENING AT THE DISTAL SEGMENT. PHYSICIAN EXPLAINED A STENOSIS IN THE AREA OF CONCERN CAUSED BY A PREVIOUSLY PLACED NON-STRYKER FLOW DIVERTER DEVICE COULD HAVE RESULTED IN SUBJECT STENT OPENING DIFFICULTY. THE OPERATOR ATTEMPTED ANGIOPLASTY, BUT THE SUBJECT FLOW DIVERTER STILL DID NOT OPEN AND FLOW BEYOND SUBJECT STENT WAS LIMITED WHICH MAY HAVE CAUSED A STROKE. THE FLOW DIVERTER ONLY OPENED AFTER A THIRD ANGIOPLASTY WITH MORE PRESSURE. HOWEVER, THE VESSEL RUPTURED CAUSING CONTRAST EXTRAVASATION. AS A RESULT, THE PATIENT WAS DEEMED AS MEETING "BRAIN DEATH" CRITERIA AS THERE WAS NO DISTAL PERFUSION BEYOND THE INTERNAL CAROTID ARTERY (ICA). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 20107495 ↗
• MalfunctionApr 18, 2024Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT DURING AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM CASE, MIDDLE SEGMENT OF THE SUBJECT FLOW DIVERTER STENT WAS NOT OPENING. PHYSICIAN TRIED TO RE-SHEATH THE SUBJECT STENT BUT FAILED. THEREFORE, THE SUBJECT STENT WAS LEFT INSIDE THE PATIENT¿S BODY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT. UPDATE: IT WAS REPORTED THAT DURING AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM CASE, MIDDLE SEGMENT OF THE SUBJECT FLOW DIVERTER STENT WHICH WAS IN A CURVE WAS NOT OPENING. PHYSICIAN TRIED TO RE-SHEATH THE SUBJECT STENT BACK INTO MICROCATHETER BUT FAILED. THEREFORE, THE SUBJECT STENT WAS COMPLETELY DEPLOYED INSIDE THE PATIENT¿S BODY AND BALLOON ANGIOPLASTY WAS PERFORMED TO OPEN THE SUBJECT STENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132233 ↗
• InjuryNov 1, 2023Adverse 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 A PATIENT ON (B)(6) 2021. POST PROCEDURE ON (B)(6) 2021 PATIENT COMPLAINED OF BLURRED VISION AND RIGHT HAND NUMBNESS. THE ADVERSE EVENTS (AE) OUTCOME WAS INDICATED AS RECOVERED/RESOLVED ON (B)(6) 2021. NO TREATMENT WAS PROVIDED FOR THE REPORTED ADVERSE EVENTS. THE ADVERSE EVENTS WERE INDICATED AS POSSIBLY RELATED TO STUDY PROCEDURE, STUDY DEVICE, DAPT (DUAL ANTIPLATELET THERAPY) , DISEASE UNDER STUDY AND AN UNDERLYING CONDITION OR DISEASE. IT WAS NOTED THAT THE PATIENT HAS A PAST MEDICAL HISTORY OF HYPERTENSION, CURRENT SMOKER, LOCALIZED HEADACHE, CAROTID ARTERY STENOSIS, DEPRESSION, ANXIETY, DYSLIPIDEMIA, IDIOPATHIC NEUROPATHY, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, GASTROESOPHAGEAL REFLUX DISEASE.

  Patient problems: Numbness; Visual Disturbances

  MAUDE report 18044879 ↗
• InjuryOct 26, 2023Adverse 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 A PATIENT ON (B)(6) 2022. POST PROCEDURE SOMETIME IN (B)(6) 2023 PATIENT EXPERIENCED INTERMITTENT VISION LOSS OF RIGHT EYE. IT WAS REPORTED THAT TRANSIENT VISUAL LOSS RIGHT EYE RESOLVED/RECOVERED WITHOUT ANY TREATMENT SOMETIME IN (B)(6) 2023. IT IS INDICATED THAT THE TRANSIENT VISUAL LOSS RIGHT EYE IS POSSIBLY RELATE TO THE STUDY DEVICE. THE PATIENT HAS A PAST MEDICAL HISTORY OF SEVERE HEADACHE/MIGRAINE, DEPRESSION/ANXIETY, DYSLIPIDEMIA, OBESITY, ESSENTIAL TREMOR, VERTIGO, ETC. IT IS INDICATED THAT THE TRANSIENT VISUAL LOSS RIGHT EYE WAS CLASSIFIED AS NON-SERIOUS ADVERSE EVENT.

  Patient problems: Visual Disturbances

  MAUDE report 18016658 ↗
• DeathOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JUST AFTER DEPLOYING THE SUBJECT FLOW DIVERTER STENT THE ICA (INTERNAL CAROTID ARTERY) RUPTURED AT THE VERY DISTAL ASPECT OF THE STENT OR IMMEDIATELY DISTAL TO SUBJECT STENT. EXTRAVASATION WAS NOTED ON DSA (DIGITAL SUBTRACTION ANGIOGRAPHY). ANESTHESIA NOTED AN IMMEDIATE SPIKE IN BLOOD PRESSURE JUST AFTER DEPLOYMENT, A FOLLOWING DSA RUN SHOWED EXTRAVASATION. BALLOON ASSISTED COILING WAS USED TO STOP BLOOD FLOW VIA ICA SACRIFICE. PATIENT WAS PUT ON INTRAPROCEDURAL EVD (EXTERNAL VENTRICULAR DRAIN). APPROXIMATELY 2 HOURS OF BALLOON ASSISTED COILING TO SACRIFICE THE ICA. PATIENT EXPIRED IN THE ICU (INTENSIVE CARE UNIT) LATER THAT DAY.

  Patient problems: Extravasation; Rupture

  MAUDE report 17887078 ↗
• InjuryAug 9, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT (SUBJECT DEVICE) WAS PLACED INSIDE OF A LEFT ICA VESSEL. UPON FULL DEPLOYMENT THE PROXIMAL END OF THE STENT (SUBJECT DEVICE) FAILED TO ADEQUATELY OPEN FULLY AND APPOSE TO THE VESSEL WALL. THE PHYSICIAN ATTEMPTED TO OPEN THE PROXIMAL OF THE SUBJECT STENT WITH GUIDEWIRE MANIPULATION AND A BALLOON BUT WAS UNSUCCESSFUL. A SECOND STENT WAS DEPLOYED TO ADEQUATELY OPEN THE PROXIMAL END OF THE FIRST STENT (SUBJECT DEVICE). THERE WAS A SURGICAL DELAY OF 2-3 HOURS. 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 17486956 ↗
• InjuryJul 20, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR AN INTRACRANIAL ANEURYSM, THE PROXIMAL END OF THE SUBJECT STENT WAS FISH MOUTHED, AND WOULD NOT OPEN. THE MIDDLE OF THE STENT AT THE ANTERIOR GENU WAS NOT FULLY OPPOSED. THE PHYSICIAN WANTED TO RIDE THE MICROCATHETER THROUGH THE SUBJECT STENT, OVER THE DELIVERY WIRE TO CAPTURE THE PEDALS, HOPING THAT IT WOULD OPEN THE MID BODY OF THE STENT. THAT MOVE DIDN'T HELP SO THE PHYSICIAN GOT THE GUIDEWIRE AT PUT A BIG J ON IT. WHEN ATTEMPTING TO RE-ACCESS, GUIDEWIRE WENT ABOVE THE STENT AND MADE IT FISH MOUTHED EVEN MORE. THE PHYSICIAN THEN PLACED ANOTHER STENT TO TRY TO PROP OPEN THE PROXIMAL END OF THE SUBJECT STENT. THAT HELPED, BUT DID NOT OPEN IT. THEN BALLOON WAS TRIED BUT COULDN'T REACCESS. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT AS THE PATIENT HAD GOOD COLLATERALS. THERE WAS PROLONGATION OF THE PROCEDURE DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368133 ↗
• InjuryJun 28, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR AN ANEURYSM ORIGINATING OFF THE SUPERIOR ASPECT OF HORIZONTAL CAVERNOUS SEGMENT, THE SUBJECT STENT CAME OFF REHEATH PAD PREMATURELY IN OPHTHALMIC SEGMENT OF INTERNAL CAROTID ARTERY ICA. THE SUBJECT STENT DID NOT COVER THE NECK OF THE ANEURYSM. THE ANEURYSM WAS TREATED WITH ANOTHER STENT AND COILS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216279 ↗
• DeathJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER STENT WAS IMPLANTED SUCCESSFULLY IN THE PATIENT ON (B)(6) 2022 TO TREAT INTRACRANIAL ANEURYSM IN THE RIGHT ICA (INTERNAL CAROTID ARTERY) COMMUNICATING (C7 SEGMENT). POST PROCEDURE ON (B)(6) 2022 THE PATIENT STARTED EXPERIENCING SHARP RIGHT FRONTAL REGION HEADACHE ALONG WITH CHEST PAIN, DIZZINESS, NAUSEA AND VOMITING. PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2022 AND WAS ADMITTED (B)(6) 2022. CT (COMPUTERIZED TOMOGRAPHY ), CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) HEAD/NECK, MIR (MAGNETIC RESONANCE IMAGING), STRESS TEST, MOSTLY UNREMARKABLE AND NEGATIVE FOR SAH (SUBARACHNOID HEMORRHAGE) OR ICH (INTRA-CEREBRAL HEMORRHAGE). PATIENT WAS GIVEN LOVENOX 40MG ONCE A DAY AND REGLAN 10MG ONCE IV PER SITE REPORTING. SYMPTOMS RESOLVED AND SHE WAS DISCHARGED ON (B)(6) 2022. THE EVENT WAS CLASSIFIED A SERIOUS ADVERSE EVENT ON (B)(6) 2022. THE ADVERSE EVENT OUTCOME WAS NOTED TO BE RECOVERED/ RESOLVED. IT IS INDICATED THAT THE ADVERSE EVENT WAS UNLIKELY RELATED TO THE STUDY PROCEDURE AND STUDY DEVICE. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 15-NOV-2023 REPORTED THAT A NEW EVENT ADVERSE EVENT AE#3 DEATH WAS REPORTED

  Patient problems: Chest Pain; Dizziness; Headache; Nausea; Vomiting

  MAUDE report 17088246 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROCEDURE WITH THE SUBJECT FLOW DIVERTER STENT ON (B)(6) 2023 PATIENT DEVELOPED 'MODERATE HEADACHE' FOLLOWING THE PROCEDURE, WHICH WAS AS RESOLVED WITH PAIN MEDICATION. THE RATIONALE FOR RELATIONSHIP TO THE STUDY DEVICE WAS INFERRED AS, 'FLOW DIVERTER PLACEMENT COULD CAUSE HEADACHE'. THE HEADACHE WAS REPORTED TO BE POSSIBLY RELATED TO THE STUDY PROCEDURE, THE STUDY DEVICE, DISEASE UNDER STUDY AND UNDERLYING CONDITION OR DISEASE. THE 'HEADACHE' WAS RESOLVED ON (B)(6) 2023. IT WAS ALSO REPORTED THAT TWO DAYS POST PROCEDURE WITH THE SUBJECT FLOW DIVERTER STENT ON (B)(6) 2023 THE PATIENTS LEFT EYE BECAME SWOLLEN AND MODERATELY PAINFUL, PATIENT WAS PUT ON TWO WEEK COURSE OF DEXAMETHASONE MEDICATION. THE SWELLING AND PAIN IN THE LEFT EYE WAS REPORTED TO BE POSSIBLY RELATED TO THE STUDY PROCEDURE AND THE STUDY DEVICE. THE RATIONALE FOR RELATIONSHIP TO THE STUDY DEVICE WAS INFERRED AS POSSIBLE VENOUS CONGESTION IN ORBIT FROM MASS EFFECT FROM ANEURYSM AS IT THROMBOSES. THE SWELLING AND PAIN IN THE LEFT EYE RESOLVED ON (B)(6) 2023.

  Patient problems: Eye Pain; Headache; Swelling/ Edema

  MAUDE report 16475544 ↗
• InjuryDec 12, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PARAOPTHALMIC ANEURYSM PROCEDURE, THE PHYSICIAN WAS UNABLE TO FULLY OPEN THE SUBJECT FLOW DIVERTING STENT AT THE TARGET LESION. IT WAS RESHEATHED AND AFTER THE 3RD RESHEATHING ATTEMPT, THE SUBJECT FLOW DIVERTING STENT DEPLOYED PREMATURELY WITHIN THE MICROCATHETER. DURING MANIPULATION TO PROPERLY DEPLOY THE SUBJECT FLOW DIVERTING STENT THE LEFT INTERNAL CAROTID ARTERY (ICA) GOT DISSECTED AND THE PROCEDURE WAS ABORTED. THE SUBJECT FLOW DIVERTING STENT WAS REMOVED WITH THE MICROCATHETER. PATIENT WAS GIVEN HEPARIN, ASPRIN (ASA) AND BILLINTA AND ALSO DISCHARGED ON (B)(6) 2022. IMAGING WAS PERFORMED WHICH SHOWED DISSECTION BUT PATENT FLOW WITH AREAS OF STENOSIS. THE COLLATERAL FLOW WAS STARTED DUE TO WHICH THE FLOW WASN'T SHUT COMPLETELY. THE PATIENT WAS STABLE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 15957493 ↗
• InjuryOct 11, 2022Migration; Migration

  IT WAS REPORTED THAT A NEUROVASCULAR PROCEDURE WAS PERFORMED IN A PATIENT FOR STENT IMPLANTATION ON (B)(6) 2022. ON SIX MONTH FOLLOW-UP IT WAS NOTED THAT PROXIMAL END OF SUBJECT FLOW DIVERTER STENT HAD MIGRATED DISTALLY AND APPEARS TO BE LARGER AT THE NECK OF THE ANEURYSM. THE SUBJECT STENT SHOWED STENOSIS, MORE WORSE ON THE PROXIMAL END AND BOTH THE PROXIMAL AND DISTAL ENDS OF THE SUBJECT FLOW DIVERTER STENT ARE FISH MOUTHED. THE PERCENTAGE OF STENOSIS IS UNKNOWN. THE PATIENT IS REPORTED TO HAVE HAD TWO STROKES DUE TO THE REPORTED ISSUE AND THE PATIENT IS ON DAPT (DUAL ANTIPLATELET THERAPY) WHICH IS EXTENDED INDEFINITELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Stenosis; Stroke/CVA

  MAUDE report 15577372 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS IMPLANTED AT LT INTERNAL CAROTID OPHTHALMIC SEGMENT. TWO DAYS AFTER THE PROCEDURE THE PATIENT HAD CONTRAST INDUCED ENCEPHALOPATHY REACTION. THERE IS A POSSIBLE RELATIONSHIP BETWEEN THE STENT (SUBJECT DEVICE) AND THIS REACTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Encephalitis

  MAUDE report 15435811 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STENT IMPLANTATION PROCEDURE WAS PERFORMED IN A PATIENT FOR INTRACRANIAL ANEURYSM IN LEFT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) ON (B)(6) 2022. INTRAPROCEDURAL IMAGING WAS PERFORMED POST SUBJECT FLOW DIVERTER STENT IMPLANTATION. THE CORE LAB REPORT FOR THE THROMBOEMBOLIC ASSESSMENT (TE) INDICATES ¿NON-OCCLUSIVE THROMBUS IN PARENT ARTERY WITHIN THE SUBJECT FLOW DIVERTER STENT ¿. FURTHERMORE THE CORE LAB COMMENTED THAT ¿POSSIBLY SMALL AMOUNT OF THROMBUS IN DISSECTION OF PARENT ARTERY WITHIN SUBJECT FLOW DIVERTER STENT¿. IT WAS ASSESSED THAT SUBJECT FLOW DIVERTER STENT WAS FULLY APPOSED TO THE PARENT ARTERY. HOWEVER THE CORE LAB COMMENTED ¿DISSECTION OF PARENT ARTERY WITHIN STENT LIKELY CAUSED BY A NON- STRYKER INTERMEDIATE CATHETER¿. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Headache; Thrombosis/Thrombus

  MAUDE report 15291435 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN THE CLINICAL TRIAL THE SUBJECT FLOW DIVERTER STENT WAS IMPLANTED IN A PATIENT ON (B)(6) 2021 TO TREAT INTRACRANIAL ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY-COMMUNICATING (C7 SEGMENT) AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. SIX MONTHS POST PROCEDURE THE FOLLOW-UP LAB FINDINGS NOTED THAT THE PATIENT HAD 50-75% IN-STENT STENOSIS WITHIN THE SUBJECT FLOW DIVERTER STENT. THERE ARE NO AES REPORTED BY THE SITE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Headache; Stenosis

  MAUDE report 14541101 ↗
• MalfunctionApr 14, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A NEUROVASCULAR SURGICAL PROCEDURE WAS PERFORMED IN A PATIENT WITH CAVERNOUS ANEURYSM. DURING THE PROCEDURE THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE SUBJECT FLOW DIVERTER TO THE TARGET LESION. AT THE TARGET LESION THE PHYSICIAN FELT THE SUBJECT FLOW DIVERTER DIDN¿T FEEL AS SMOOTH AS USUAL AND DIDN¿T WANT TO FORCE IT TO OPEN, THEREFORE THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE SUBJECT FLOW DIVERTER BUT INCREASED RESISTANCE WAS FELT WHEN THE SUBJECT FLOW DIVERTER WAS RE-SHEATHED. THE SUBJECT FLOW DIVERTER ALONG WITH THE MICROCATHETER WERE REMOVED FROM THE PATIENTS VASCULATURE. THE SUBJECT FLOW DIVERTER AND THE MICROCATHETER WERE 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 14114587 ↗
• InjuryJan 20, 2022Migration; Migration

  IT WAS REPORTED THAT DURING THE TREATMENT OF A MICRO PERFORATION AT M2 OF LEFT MCA, PHYSICIAN USED THE MICROCATHETER AND GUIDEWIRES TO DEPLOY THE SUBJECT FLOW DIVERTING STENT. HE RE -SHEATHED THE SUBJECT STENT AND DURING DEPLOYMENT IT WAS SLIGHTLY MIGRATED TO FORWARD DIRECTION WHILE APPLYING FORWARD PRESSURE TO DELIVERY SYSTEM AND COVERED THE MCA BRANCH. 15 MINUTES POST DEPLOYMENT PHYSICIAN NOTICED CONTRAST LEAKING DISTAL TO THE SUBJECT STENT INDICATING VESSEL PERFORATION. ON REVIEW OF IMAGING, IT WAS CLEARED THAT THE PERFORATION HAPPENED BEFORE SUBJECT STENT DEPLOYMENT AND AFTER THE PLACEMENT OF MICROCATHETER AND GUIDEWIRES. IT IS UNDETERMINABLE IF THE DEVICES CAUSED THE PERFORATION. BALLOON ANGIOPLASTY WAS PERFORMED TO STOP BLEEDING AND PROTAMINE WAS ADMINISTERED TO REVERSE HEPARIN. 4 HOURS POST PROCEDURE PATIENT STARTED BLEEDING AGAIN AT M1/M2 BIFURCATION. ANOTHER SURGERY WAS PERFORMED TO REMOVE THE BLOOD FROM BRAIN AND THE SUBJECT STENT WAS SEEN PROTRUDING FROM THE VESSEL. IT IS UNDETERMINABLE IF THE SUBJECT STENT CAUSED THE PERFORATION. PATIENT SUFFERED PARALYSIS AND IS CURRENTLY IN ICU. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Brain Injury; Intracranial Hemorrhage; Loss of consciousness; Paralysis; Paresis; Perforation of Vessels

  MAUDE report 13310701 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER A SUCCESSFUL CLINICAL TRIAL PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY-CLINOID (C5 SEGMENT) TO TREAT A FUSIFORM INTRACRANIAL ANEURYSM MEASURING 6.2MM, THE PATIENT HAD A MINIMAL TRANSIENT HEADACHE ON THE SAME DAY. NO DIAGNOSTIC TESTS, INTERVENTION, TREATMENT OR HOSPITALIZATION WERE DONE DUE TO HEADACHE AND IT WAS REPORTED AS RECOVERING/RESOLVING. THE PATIENT ALSO HAD VISION IMPAIRMENT, 1 DAY POST PROCEDURE. THIS PRESENTED AS MORNING VISUAL CHANGES IN THE LEFT EYE AND SEEING SHADOWS WHEN LOOKING AT LETTERS BUT NOT IMAGES. NO DIAGNOSTIC TESTS, INTERVENTION, TREATMENT OR HOSPITALIZATION WERE DONE DUE TO THE VISION CHANGES AND IT WAS REPORTED AS RECOVERING/RESOLVING. THE SITE REPORTED THE HEADACHE AS PROBABLY RELATED AND THE VISUAL IMPAIRMENT AS CAUSALLY RELATED TO THE SUBJECT FLOW DIVERTER.

  Patient problems: Headache; Visual Impairment

  MAUDE report 13260426 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE PATIENT FOLLOW UP, IT WAS DETERMINED THAT THE PATIENT DEVELOPED ENDOLUMINAL INTIMAL HYPERPLASIA. THE LOCATION OF THE IMPLANT WAS IN THE VASCULATURE ICA (INTERNAL CAROTID ARTERY). UPON MULTI PHYSICIAN CONFERENCE, IT WAS SUGGESTED THAT THE SUBJECT SURPASS EVOLVE STENT COULD BE THE CAUSE. THE PATIENT¿S CURRENT CONDITION IS ASYMPTOMATIC AND THERE WAS NOT ANY MECHANICAL INJURY TO ARTERY AT THE LOCATION OF THE HYPERPLASIA VIA ANGIOGRAPHY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hyperplasia; Stenosis

  MAUDE report 12977690 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER DEVELOPED IN-STENT THROMBOSIS DURING THE PROCEDURE, WHICH WAS TREATED USING ANOTHER STENT AND MEDICATION. THE THROMBOTIC EVENT IS RELATED TO THE STUDY PROCEDURE AND SUBJECT DEVICE. THE EVENT RESOLVED AND PATIENT RECOVERED. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 18-MAY-2021 REPORTED THAT THE PATIENT HAD A GENERALIZED HEADACHE POST PROCEDURE, ON THE SAME DAY OF THE PROCEDURE. HEADACHE WAS CLASSIFIED AS GENERALIZED, NON SERIOUS AND WAS TREATED WITH ORAL MEDICATION (ACETAMINOPHEN 650MG) ONCE DAILY AND IT RESOLVED. THE HEADACHE WAS POSSIBLY RELATED TO THE SUBJECT FLOW DIVERTER AND NO DIAGNOSTIC IMAGING WAS PERFORMED AS A RESULT OF THE HEADACHE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache; Thrombosis/Thrombus

  MAUDE report 11206086 ↗