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WEB W5-5-2-MVI-3Recalls & reported problems

Microvention, Inc. · WEB 17 SL 5x2 · Class 3 · Implant

All models of WEB (14)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
20
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00842429110843), received between Jan 26, 2022 and Feb 19, 2026 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (8 reports).

1 other recall cover devices cleared under the same FDA submission (P170032); they may or may not involve this specific model.

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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult or Delayed Separation8
  • Separation Failure7
  • Adverse Event Without Identified Device or Use Problem5
  • Device Dislodged or Dislocated3
  • Material Deformation2
  • Deformation Due to Compressive Stress1
  • Detachment of Device or Device Component1
  • Separation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions14
  • Paresis2
  • Aneurysm1
  • Aneurysm expansion1
  • Extravasation1
  • Intracranial Hemorrhage1
  • Ischemia Stroke1
  • Obstruction/Occlusion1

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

    AS REPORTED THROUGH THE CLINICAL STUDY WEB PAS: ORIGINALLY NOTED AS POSSIBLE, PROBABLE OR CAUSAL RELATION TO STUDY DEVICE OR INDEX PROCEDURE EVENT TERM: RECURRENT R MCA ANEURYSM. THE INDEX PROCEDURE WAS ON (B)(6) 2025. PER THE HOSPITAL, FOLLOW-UP IMAGING IN (B)(6) 2026 SHOWED: 3D ROTATIONAL ANGIOGRAM WITH RIGHT ICA INJECTION DEMONSTRATES A 1.7 X 2.1 MM RESIDUAL RIGHT MCA BIFURCATION ANEURYSM DOME/NECK STATUS POST PRIOR WEB TREATMENT. THERE HAS BEEN NO ADDITIONAL TREATMENT OUTSIDE OF IMAGING DONE TO IDENTIFY ANEURYSM RECURRENCE. CURRENTLY THERE HAS BEEN NO ADDITIONAL TREATMENT AND NONE NOTED TO BE PLANNED. THE PATIENT IS AWAITING 2-YEAR FOLLOW-UP. EVENT START DATE: 21-JAN-2026 WAS THIS A SERIOUS AE? NO INTERVENTION: X WAS THE AE CAUSED BY OR ASSOCIATED WITH A TECHNICAL EVENT? : NO RELATIONSHIP TO STUDY DEVICE: PROBABLE RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLE RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED RELATIONSHIP TO STUDY DISEASE: POSSIBLE RELATIONSHIP TO CONCOMITANT DISEASE: NOT RELATED AE OUTCOME: ONGOING ADDITIONAL AUTO ALERT RECEIVED NOTED: WAS THIS A SERIOUS AE? NO NONE: X RELATIONSHIP TO STUDY DEVICE: CAUSAL THE RECURRENT R MCA ANEURYSM IS NOW INDICATE

    Patient problems: Aneurysm expansion

    MAUDE report 24391375 ↗
  • MalfunctionFeb 10, 2026Separation Failure

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE WEB DEVICE WAS DEPLOYED, THE VIA CATHETER WAS RETRACTED, THE WEB DEVICE WAS DETACHED, AND THE PUSHER WIRE WAS REMOVED FROM THE CATHETER. WHEN THE PHYSICIAN RETRACTED THE VIA CATHETER, SOMETHING REMAINED ATTACHED TO THE WEB DEVICE AND CAUSED THE WEB TO BE PULLED SLIGHTLY OUT OF THE ANEURYSM. THE PHYSICIAN THEN INSERTED A WIRE INTO THE VIA CATHETER, AND UNDER FLUOROSCOPIC IMAGING IT WAS OBSERVED THAT THE VIA CATHETER DETACHED FROM THE WEB DEVICE. THE CASE WAS SUBSEQUENTLY COMPLETED WITHOUT FURTHER COMPLICATION. THE PATIENT WAS REPORTED TO BE STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24310573 ↗
  • InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT ENROLLED IN THE WEB PAS CLINICAL STUDY WAS NOTED TO HAVE A COMPACTED WEB DURING THEIR ONE YEAR DSA IMAGING. THE PATIENT HAD AN ADDITIONAL SURGERY TO IMPLANT AN EMBOLIZATION COIL AND A STENT IN ORDER TO TREAT THE ANEURYSM RECURRENCE.

    Patient problems: Aneurysm

    MAUDE report 22432860 ↗
  • InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY: TARGET ANEURYSM WITH INCREASED COMPACTION AND RESIDUAL FILLING. RETREATMENT WAS PERFORMED TWO AND A HALF WEEKS LATER. INDEX PROCEDURE WAS PERFORMED ELEVEN AND A HALF MONTHS PRIOR (TO THE RETREATMENT) WITH THE RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATION ARTERY COMPLEX. THIS EVENT OUTCOME IS RECOVERED / RESOLVED ON THE RETREATMENT DAY. THE RELATION BETWEEN THE STUDY DEVICE AND REPORTED EVENT IS CAUSAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22333042 ↗
  • InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED THROUGH THE CLINICAL STUDY WEB PAS: EVENT #: 4 AE DESCRIPTION: ON POD 204 ¿FOLLOW UP MR IMAGING DEMONSTRATED INTERVAL TREATMENT OF ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A WEB DEVICE. SUSPECT 3 X 1 MM FOCUS OF RESIDUAL ANEURYSMAL FLOW ALONG THE LEFT ANTERIOR ASPECT OF THE WEB DEVICE. PRESUMED TINY MICROHEMORRHAGES IN LEFT CEREBELLUM AND RIGHT ANTERIOR FRONTAL LOBE. RECOMMEND CORRELATION WITH MRI OF THE BRAIN. MRI BRAIN WITHOUT GAD ON (B)(6) 2025 DEMONSTRATED TINY SUSCEPTIBILITY ARTIFACTS ARE AGAIN SEEN WITHIN THE LEFT CEREBELLUM AND RIGHT POSTERIOR AND ANTERIOR INFERIOR RIGHT PARASAGITTAL FRONTAL LOBE, LIKELY A SEQUELA OF PRIOR MICROBLEEDS.¿ EVENT TERM: FOLLOW UP IMAGING MRA. EVENT START DATE: 28-JAN-2025. WAS THIS A SERIOUS AE? NO. WAS THE AE CAUSED BY OR ASSOCIATED WITH A TECHNICAL EVENT? : NO. RELATIONSHIP TO STUDY DEVICE: NOT RELATED. RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: NOT RELATED. RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED. RELATIONSHIP TO STUDY DISEASE: NOT RELATED. RELATIONSHIP TO CONCOMITANT DISEASE: PROBABLE. AE OUTCOME: RECOVERED/RESOLVED. RECOVERED/RESOLVED: DATE OF RESOLUTION: (B)(6) 2025. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. REL

    Patient problems: Intracranial Hemorrhage

    MAUDE report 22145165 ↗
  • InjuryMay 30, 2025Unintended Movement; Difficult or Delayed Separation; Unintended Movement; Difficult or Delayed Separation

    AS REPORTED: BASILAR APEX ANEURYSM. THE PHYSICIAN DEPLOYED WEB SL5X2 AND HAD A DIFFICULT DETACHMENT AND NEEDED TO STENT ACROSS LEFT P1 BECAUSE THE DEVICE WAS LIMITING FLOW. THE PHYSICIAN ATTEMPTED TO DETACH PUSHER WIRE FROM IMPLANT BY ADVANCING VIA MICROCATHETER UP TO THE PROXIMAL MARKER AND HOLDING TENSION. PHYSICIAN DEPLOYED A LVIS EVO 3.5X17 AND WHEN RE-SHEATHING; THE STENT INTERFERED WITH THE WEB PROXIMAL MARKER AND BOTH THE WEB AND STENT WERE INTERTWINED AND "CINCHED" IN THE VIA-17 MICROCATHETER. THE PHYSICIAN ADVANCED THE BENCHMARK AND SOFIA 5 FR 125 DISTAL AND TOOK THE WHOLE SYSTEM OUT. HE RE-ACCESSED THE ANEURYSM AND SUCCESSFULLY DEPLOYED ANOTHER WEB SL 5 X 2 WITH NO ISSUES AND NO STENT. THE PATIENT IS GOOD AND WAS DISCHARGED THE FOLLOWING DAY. NO OTHER INCIDENT INFORMATION WAS PROVIDED, HOWEVER THE DEVICE WAS RETURNED AND EVALUATED. PLEASE SEE D10, H3, H6 AND H11.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22120258 ↗
  • MalfunctionJan 8, 2025Separation Failure; Separation Failure

    IT WAS REPORTED THAT THE WEB EMBOLIZATION DEVICE WAS USED IN A PROCEDURE TO TREAT A RUPTURED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. AFTER DEPLOYMENT THE DEVICE WOULD NOT DETACH WHEN ATTEMPTED WITH A DETACHMENT CONTROLLER. THE PHYSICIAN WAS ABLE TO RE-SHEATH AND REMOVE THE DEVICE. ANOTHER WEB DEVICE OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21108178 ↗
  • MalfunctionNov 18, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

    IT WAS REPORTED THAT THE WEB DID NOT DETACH UPON FIRST DETACHMENT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO DETACH THE DEVICE WITH THE FIRST DETACHMENT CONTROLLER AND EVENTUALLY DETACHED WITH THE SECOND WDC CONTROLLER. A REPEAT CT ANGIOGRAM WAS DONE WHICH CONFIRMED PATENCY OF BOTH M2 BRANCHES. THE PATIENT WAS REPORTED TO BE STABLE AND WAS DISCHARGED. NO PATIENT HARM OR INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20703379 ↗
  • InjurySep 23, 2024Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

    AS REPORTED: SAH PATIENT WITH A RUPTURED RMCA BIFURCATION ANEURYSM. DUE TO SAH STATUS, PATIENT WAS NOT ON DAPT AND NO ANTICOAGULANT MEDICATION WAS GIVEN DURING CASE. NO INTERMEDIATE CATHETER WAS USED DURING THIS CASE. BALLOON CATHETER REMAINED OUT RMCA BRANCH DURING CASE. WEB 17 5X2SL WAS DEPLOYED IN ANEURYSM. UPON MEASURING POST DEPLOYMENT, THE WEB WIDTH MEASURED APPROXIMATELY 4.8MM IN ONE DIMENSION AND 4.2MM IN A SECOND DIMENSION AND THERE APPEARED TO BE AT LEAST 1MM OF NECK REMNANT. 5X2SL WAS RESHEATHED AND REMOVED. 5X2SL WAS THEN CLEANED AND REPREPPED IN CASE IT WAS STILL NEEDED. 6X2SL WEB WAS PREPPED THEN DEPLOYED INTO RMCA BIFURCATION ANEURYSM. INITIAL DEPLOYMENT SHOWED WEB WAS PROTRUDING INTO PARENT VESSEL AND IMPINGING ON A BRANCH COMING OFF THE NECK. ADDITIONAL MANIPULATION WAS DONE TO WEB AND FOLLOW-UP IMAGING SHOWED WEB SITTING MORE IN ANEURYSM WITH LESS THAN 50% IMPINGEMENT. PHYSICIAN CHOSE TO RESHEATH AND REMOVE 6X2SL. THE PREVIOUSLY PREPPED 5X2SL WAS REINSERTED AND DEPLOYED INTO THE ANEURYSM AGAIN. IMAGING SHOWED NECK REMNANT. WEB WAS PULLED BACK ON SLIGHTLY WHICH LESSENED THE NECK REMNANT. PHYSICIAN CHOSE TO DETACH WEB AT THIS TIME. AFTER MULTIPLE CYCLES WITH THE DET

    Patient problems: Thrombosis/Thrombus

    MAUDE report 20287602 ↗
  • MalfunctionSep 4, 2024Separation Failure; Separation Failure

    AS REPORTED: WHEN THE WEB WAS ATTEMPTED TO BE DETACHED WITH THE DETACHMENT CONTROLLER, RED LIGHT WAS ON. WEB WAS NOT DETACHED AND BOTH WEB AND DETACHMENT CONTROLLER ARE REPLACED WITH NEW ONES AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY. PATIENT IS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20140637 ↗
  • InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED: THE PHYSICIAN WAS TREATING A LT MCA BIFURCATING ANEURYSM. HE USED A NEURON MAX AS HIS SHEATH AND A 5F 115CM SOFIA EX AS HIS INTERMEDIATE CATHETER AND A VIA 17 45 DEGREE MICROCATHETER. HE HAD THE VIA 17 POSITIONED NICELY IN THE MID PORTION OF THE ANEURYSM AND AS HE WAS SLOWLY DEPLOYING THE WEB DEVICE, THE PATIENT STARTED WAKING UP AND COUGHING. AFTER MORE PARALYTICS WERE GIVEN (PROTAMINE WAS GIVEN TO REVERSE THE HEPARIN) THE PHYSICIAN DID ANOTHER RUN TO MAKE SURE EVERYTHING WAS OK. DURING THIS RUN SOME EXTRAVASATION WAS NOTICED. THE PHYSICIAN THEN DEPLOYED THE WEB, NOTICED IT WASN'T SITTING APPROPRIATELY; IT WAS OUTSIDE THE ANEURYSM AND PULLED THE WEB BACK TO SEAL THE RUPTURE POINT. HE DID ANOTHER RUN AND THERE WAS NO MORE EXTRAVASATION. HE DID A DYNA CT AND NOTICE SOME BLOOD IN THE VENTRICLES. HE THEN DEPLOYED THE WEB SEALING THE RUPTURE POINT. HE REMOVED EVERYTHING AND TOOK THE PATIENT TO CT FOR A BETTER SCAN. HERE HE NOTICED SOME BLOOD/CONTRAST IN THE VENTRICLES. HE SENT THE PATIENT TO THE ICU TO RECOVER AND BE EXTUBATED. THE NEXT MORNING IT IS NOTED THE PATIENT WASN¿T ABLE TO MOVE HER RIGHT ARM. AN MRI IS PROPOSED NEXT AND TO OBSERVE HOW SHE RECOVERS. IN ADDITIO

    Patient problems: Extravasation; Ischemia Stroke; Paresis

    MAUDE report 19634510 ↗
  • MalfunctionMay 9, 2024Separation Failure; Separation Problem; Separation Failure; Separation Problem

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SECOND WDC WAS USED PER THE INSTRUCTIONS FOR USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19282950 ↗
  • MalfunctionApr 3, 2024Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

    IT WAS REPORTED THAT A WEB DEVICE DID NOT DETACH WITH A DETACHMENT CONTROLLER. THE WEB WAS REMOVED AND DETACHED IN THE MICROCATHETER. IT WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WAS NO INTERVENTION OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19038215 ↗
  • MalfunctionMar 7, 2024Separation Failure; Separation Failure

    IT WAS REPORTED, WEB WAS IMPLANTED IN ANEURYSM AND READY TO DETACH. PHYSICIAN MADE SURE SYSTEM WAS IN NEUTRAL AND PROCEEDED TO DETACH. UPON DETACHMENT, A SLIGHT MOVEMENT OF THE WEB DETACHMENT ZONE WAS VISIUALIZED. THE PHYSICIAN PROCEEDED TO PULL WEB WIRE. AS THE PHYSICIAN PULLED THE WEB WIRE, THE VIA 17 MOVED FORWARD AND COVERED THE MARKER. UPON FUTHER PULLING OF THE WEB WIRE, THE WEB BEGAN TO RESHEATH. THE PHSYICAN DID THIS A TOTAL OF THREE TIMES, INCLUDING MULTIPLE DETACHMENT SEQUENCES WERE ATTEMPTED WITH 2 UNITS. THE PHYSICIAN DECIDED TO TAKE THE WEB OUT AND USE A NEW ONE. THE PHYSICIAN RESHEATHED THE WEB FULLY AND GAINED ACCESS INTO THE ANEURYSM. THE WEB DETACHED IN THE VIA AS HE PULLED BACK ON THE WEB WIRE. HE HAD TO REMOVE VIA, AND ACCESS AGAIN. IT WAS REPORTED THERE WAS NO HEALTH DAMAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18862191 ↗
  • MalfunctionJan 30, 2024Separation Failure; Difficult or Delayed Separation; Separation Failure; Difficult or Delayed Separation

    NO ADDITIONAL INFORMATION WAS RECEIVED, SEE H6 & H10.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18611045 ↗
  • MalfunctionNov 2, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

    IT WAS REPORTED THEY ADVANCED THE WEB INTO THE ANEURYSM. PUT THE DETACHER ON THE PUSHER WIRE AND PUSHED THE BUTTON TWICE TO LET IT RUN THRU TWO CYCLES. NO OBVIOUS DETACHMENT SO THEY RAN THE CATHETER UP TO PROXIMAL MARKER AND TRIED A SLIGHT TUG ON PUSHER WIRE. THE WHOLE ENDED UP BEING RESHEATHED BACK INTO THE CATHETER. WE REDEPLOYED THE WEB AND USED TWO DIFFERENT DETACHERS AGAIN AND FINALLY GOT THE WEB DETACHED BY ADVANCING TWO CATHETERS UP CLOSE TO THE WEB. PROCEDURE WAS COMPLETED AND PATIENT IS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18062282 ↗
  • InjuryJun 15, 2022Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

    IT WAS REPORTED THAT A WEB DEVICE WAS ATTEMPTED TO BE IMPLANTED INTO THE ANEURYSM. WHEN DETACHING THE WEB, IT WAS OBSERVED UNDER FLUORO THE PUSHER WIRE WAS PARTIALLY SEPARATED. AFTER UNSUCCESSFUL ATTEMPTS WERE MADE TO DETACH THE PUSHER WIRE, A CATHETER WAS ABLE TO SEPARATE THE PUSHER WIRE BY APPLYING TENSION. THEN, THE WEB DETACHED AND MOVED SLIGHTLY OUT OF THE NECK OF THE ANEURYSM. A SYNCHRO WIRE WAS PLACED INTO THE A2 WITH THE CATHETER TRACKED OVER THE WIRE TO PUSH THE WEB DEEPER INTO THE ANEURYSM CLEARING THE VESSEL ENCROACHMENT SUCCESSFULLY. VESSELS AT LEVEL OF ACOM PATENT WITH BRISK FLOW. THE PATIENT IS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14708055 ↗
  • MalfunctionMay 5, 2022Deformation Due to Compressive Stress; Material Deformation; Difficult or Delayed Separation; Deformation Due to Compressive Stress; Material Deformation; Difficult or Delayed Separation

    IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO DETACH THE WEB DEVICE FROM THE PUSHER WIRE; HOWEVER, THE WEB DID NOT DETACH. A NEW CONTROLLER WAS USED AND SUCCESSFULLY DETACHED THE WEB; HOWEVER, THE TECHNIQUE USED BY THE PHYSICIAN , RESULTED IN THE CATHETER SLIGHTLY PUSHING INTO THE WEB CREATING AN INDENT ON THE PROXIMAL PORTION OF THE WEB AND EXAGGERATED THE MARKER RECESS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14294092 ↗
  • MalfunctionApr 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THROUGH ARTICLE TITLED, "BAILOUT STRATEGIES FOR ABRUPT CHANGING OF THE WOVEN ENDOBRIDGE-17 WEB-17 DEVICE ORIENTATION AFTER DETACHMENTS: TECHNICAL NOTE OF 2 ANTERIOR COMMUNICATING ARTERY ANEURYSM CASES" , THAT A PATIENT WAS BEING TREATED FOR AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A WEB-17, AND POST IMPLANTATION, MOVEMENT OF THE WEB 17 SL OCCURRED, RESULTING IN BLOCKAGE OF THE PARENT VESSEL, REQUIRING INTERVENTION OF MEDICATION AND RESCUE STENTING. A PATIENT WITH A MEDICAL HISTORY OF PRIOR STROKE WITH RESIDUAL BASELINE LEFT-SIDED WEAKNESS, PRESENTED TO AN OUTSIDE HOSPITAL FOR EVALUATION OF NEW STROKE-LIKE SYMPTOMS. THE PATIENT UNDERWENT STROKE WORK-UP AND CT ANGIOGRAPHY WHICH DEMONSTRATED AN IRREGULAR MULTILOBULATED 5.3 X 4 MM ACOM ANEURYSM. THE DECISION WAS MADE TO PROCEED WITH WEB EMBOLIZATION. A WEB-SL 17 DEVICE (4 X 4 MM) WAS DEPLOYED WITH MULTIPLE RUNS DEMONSTRATING GOOD POSITIONING OF THE DEVICE INSIDE THE ANEURYSMAL SAC. IMMEDIATELY AT DETACHMENT OF THE DEVICE AND ITS RELEASE FROM THE DELIVERY WIRE, THE DEVICE ABRUPTLY ANGLED AND PROLAPSED FROM THE SAC, MIGRATING INTO THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA), AND MOVED FURTHER INTO THE DISTAL RIGHT ACA

    Patient problems: Obstruction/Occlusion; Paresis; Stenosis

    MAUDE report 14113216 ↗
  • InjuryJan 26, 2022Device Dislodged or Dislocated; Difficult or Delayed Separation; Device Dislodged or Dislocated; Difficult or Delayed Separation

    IT WAS REPORTED THAT DURING TREATMENT OF A SCA ANEURYSM, A WEB IMPLANT DEVICE BECAME DISLODGED FROM THE ANEURYSM AFTER A DELAYED DETACHMENT. THE MICROCATHETER WAS USED TO PUSH THE WEB BACK INTO THE ANEURYSM AND A STENT WAS PLACED TO HOLD THE WEB IN POSITION. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13359936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P170032. One submission often covers many models, so check the product and lot details in each record.

  • Z-0170-2023 · Sep 21, 2022 · Open, Classified
    WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.

Other Intrasaccular Flow Disruption Device devices

All Intrasaccular Flow Disruption Device devices →

Sources and updates

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