WEB Aneurysm Embolization SystemRecalls & reported problems across all models

We found 12 models of WEB Aneurysm Embolization System by Sequent Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2019 and Apr 3, 2024 — classified as 6 deaths, 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WEB Aneurysm Embolization System problems

WEB Aneurysm Embolization System models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WEB Aneurysm Embolization System W4-4-3

  Intrasaccular Flow Disruption Device
  1 death5 reports
• WEB Aneurysm Embolization System W4-5-3

  Intrasaccular Flow Disruption Device
  1 death5 reports
• WEB Aneurysm Embolization System W4-7-3

  Intrasaccular Flow Disruption Device
  1 death5 reports
• WEB Aneurysm Embolization System W2-8-4

  Intrasaccular Flow Disruption Device
  1 death3 reports
• WEB Aneurysm Embolization System W4-6-3

  Intrasaccular Flow Disruption Device
  1 death2 reports
• WEB Aneurysm Embolization System W4-5-S

  Intrasaccular Flow Disruption Device
  1 death1 report
• WEB Aneurysm Embolization System W4-6-4

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W4-6-5

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W4-7-5

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W2-8-6

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W2-9-5

  Intrasaccular Flow Disruption Device
  1 report
• WEB Aneurysm Embolization System W2-9-4

  Intrasaccular Flow Disruption Device
  1 report

Recent WEB Aneurysm Embolization System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A WEB PAS CLINICAL STUDY, THE PATIENT HAD AN INTRAPROCEDURAL ANEURYSM RUPTURE. THE INITIAL WEB DEVICE WAS INSERTED AND THEN PROMPTLY RETRACTED AS IT WAS REPLACED WITH ANOTHER SIZED WEB AT WHICH POINT THE RUPTURE OCCURRED. THE WEB WAS IMPLANTED. THE PATIENT'S HOSPITALIZATION WAS PROLONGED. SEVEN DAYS POST-OPERATIVE, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THERE IS NO OTHER ACTION TAKEN BESIDES IMPLANTING WEB. THE PATIENT CONDITION WAS REPORTED AS MRS CHANGED FROM 0 TO 1.

  Patient problems: Ruptured Aneurysm

  MAUDE report 19038959 ↗
• InjuryAug 8, 2022Unintended Movement; Difficult or Delayed Separation; Unintended Movement; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE WEB DEVICE DID NOT FULLY DETACH ON THE FIRST DETACHMENT. THE VIA CATHETER WAS ADVANCED SLOWLY, AND WEB DETACHED. THE CASE WAS REPORTED TO BE DIFFICULT BECAUSE OF THE ANATOMY AND ANGLE OF THE WAS ANEURYSM IN WITH THE VIA 27 AND CAUSED THE WEB DEVICE TO ROTATE. AS A RESULT, THE ANEURYSM HAD A SMALL RUPTURE/BLEED AFTER, WHICH WAS TREATED WITH AN INFLATED A COMPETITOR BALLOON DEVICE FOR A FEW MINUTES, AND THE BLEEDING WAS THEN STOPPED. THE PATIENT WAS MONITORED OVERNIGHT AND DID NOT RE-RUPTURE. THE PATIENT WOKE UP OKAY AND INTACT, AND REPORTED TO BE SPEAKING AND RESPONDING CONVERSATIONALLY. THE PATIENT WAS HELD AT THE HOSPITAL FOR A FEW EXTRA DAYS FOR OBSERVATION BEFORE DISCHARGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 15188175 ↗
• InjuryMar 29, 2022Difficult to Remove; Activation Problem; Difficult to Remove; Activation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF AN ACOMM ANEURYSM, A WEB DEVICE OPENED AT THE DISTAL THIRD, BUT THE PROXIMAL TWO THIRDS WERE NOT OPENED. THE WEB COULD NOT BE RESHEATED OR OPENED, AND WAS DEPLYED IN THE ANEURYSM NECK. A STENT WAS IMPLANTED TO KEEP THE A1 AND A2 OPEN. POST PROCEDURAL IMAGING REVEALED A RESIDUAL ANEURYSM, BUT FLOW TO THE PARENT VESSEL WAS OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934930 ↗
• DeathMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WEB DEVICE WAS IMPLANTED IN A RUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY BIFURCATION ON (B)(6) 2020 WITH GOOD OCCLUSION OF THE ANEURYSM AND STAGNATE FLOW IN THE SAC. THE PATIENT WAS EVALUATED ONE MONTH POST-OP AND THE ANEURYSM DID NOT SHOW UP ON MRA. THE ANEURYSM WAS DETERMINED TO BE OCCLUDED. AT THREE MONTHS POST-OP, THE PATIENT DEVELOPED EYE PAIN. IMAGING REVEALED THE ANEURYSM HAD GROWN SIGNIFICANTLY, THE ANEURYSM APPEARED TO HAVE SIGNIFICANT FILLING IN THE NECK AND BASE OF THE ANEURYSM SAC, AND THE WEB WAS COMPACTED INTO THE DOME. THE PATIENT EXPERIENCED ACUTE SYMPTOMS WAS DIAGNOSED WITH A LARGE SUBDURAL HEMATOMA AND SUBARACHNOID HEMORRHAGE. THE PATIENT LATER PASSED AWAY.

  Patient problems: Eye Pain; Intracranial Hemorrhage

  MAUDE report 11853150 ↗
• InjuryMar 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A WEB DEVICE WAS IMPLANTED IN AN ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY. THE WEB WAS PROTRUDING INTO THE PARENT VESSEL AND CLOT FORMED. THE VESSEL WAS ATTEMPTED TO BE OPENED WITH A STENT, BUT IT WAS UNSUCCESSFUL. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11566642 ↗
• InjuryJan 9, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING PLACEMENT OF THE WEB IN AN INTERNAL CAROTID ARTERY (ICA) TERMINUS ANEURYSM, THERE WAS A SLIGHT PROTRUSION OF THE WEB. THE FOLLOWING DAY, A STENT WAS PLACED IN THE ARTERY. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS CURRENTLY REPORTED TO BE "DOING WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143894 ↗
• InjuryOct 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A RUPTURED ACOM ANEURYSM THAT HAD RE-RUPTURED PRIOR TO THE PROCEDURE. THE WEB WAS SUCCESSFULLY DEPLOYED IN THE ANEURYSM WITHOUT COMPLICATIONS. POST-PROCEDURE CT IMAGES CONFIRMED THERE WAS NO ANEURYSM RUPTURE. FOUR HOURS POST-PROCEDURE, THE ANEURYSM RE-RUPTURED. THE ANEURYSM WAS SURGICALLY TREATED THE FOLLOWING DAY. THERE WAS NO REPORTED DEVICE MALFUNCTION.

  Patient problems: Ruptured Aneurysm

  MAUDE report 10767114 ↗
• InjuryAug 14, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT AFTER THE WEB WAS IMPLANTED IN AN ACOM ANEURYSM, THE DEVICE PROTRUDED INTO THE PARENT ARTERY APPROXIMATELY 40-50%; HOWEVER, THE A2 WAS FILLING NICELY. AFTER THE PATIENT WOKE UP POST-PROCEDURE, HE HAD RIGHT SIDED WEAKNESS THAT WORSENED. THE PATIENT WAS BROUGHT BACK TO THE ANGIO SUITE AND ANGIOGRAPHY DEMONSTRATED CLOT ON THE WEB THAT EXTENDED INTO THE A2. TPA WAS DELIVERED TO THE PATIENT, WHICH DISSOLVED THE CLOT. FINAL ANGIOGRAMS LOOKED GOOD. POST-OPERATIVELY, THE PATIENT WAS PLACED ON A HEPARIN DRIP AND PRESCRIBED ASPIRIN AND PLAVIX. THERE WAS NO SEQUELA.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 10411630 ↗
• DeathAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 WITH A SUBARACHNOID HEMORRHAGE (SAH) AND TREATMENT WAS PERFORMED THE SAME DAY FOR A RUPTURED BASILAR TIP ANEURYSM. THE WEB DEVICE WAS PLACED AND A SMALL "ENCROACHMENT" WAS NOTED. FLOW IN THE VESSEL BECAME LIMITED; THEREFORE, A STENT (NOT A MICROVENTION DEVICE) WAS IMPLANTED AT THE NECK OF THE ANEURYSM WITHOUT INCIDENT. THERE WAS NO ACTIVE BLEEDING AFTER TREATMENT OF THE ANEURYSM WITH THE WEB AT THE END OF THE PROCEDURE. THE PATIENT WAS PLACED ON ASPIRIN AND PLAVIX. THE PATIENT WAS ADMITTED TO THE ICU AND THREE (3) DAYS POST-PROCEDURE ON (B)(6) 2020 THE ANEURYSM RUPTURED AGAIN. THE PATIENT DIED ON (B)(6) 2020.

  Patient problems: Death

  MAUDE report 10405738 ↗
• InjuryJul 29, 2020Separation Failure; Malposition of Device; Separation Failure; Malposition of Device

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN ANEURYSM AT THE BASILAR APEX. AFTER PLACEMENT OF THE WEB IN THE ANEURYSM, THE WEB WOULD NOT DETACH. THE MICROCATHETER WAS ADVANCED TO ASSIST IN DETACHMENT; HOWEVER, DURING THE DETACHMENT, THE WEB ROTATED AND BLOCKED APPROXIMATELY 75% OF THE POSTERIOR CEREBRAL ARTERY (PCA). A STENT WAS IMPLANTED WITHOUT INCIDENT IN THE PCA TO SUCCESSFULLY RECANALIZE THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY OR CLINICAL CONSEQUENCE. THE PATIENT IS CURRENTLY REPORTED TO BE DOING WELL.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 10341030 ↗
• InjuryJul 22, 2020Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Difficult to Remove; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM. AFTER PLACEMENT OF THE WEB IN THE ANEURYSM, THE WEB DID NOT DETACH AFTER TWO (2) ATTEMPTS. THE WEB APPEARED TO HAVE DETACHED WITH THE THIRD ATTEMPT; HOWEVER, WHEN THE PUSHER WIRE AND MICROCATHETER WERE REMOVED, THE WEB WAS PULLED OUT OF THE ANEURYSM AND THEN DETACHED IN THE INTERNAL CAROTID ARTERY (ICA). THE WEB WAS REMOVED FROM THE ICA WITH A STENT RETRIEVER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO HAVE NO DEFICIENCIES THE DAY AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10312043 ↗
• InjuryJul 9, 2020Difficult or Delayed Positioning; Separation Failure; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Separation Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN ACOM ANEURYSM. AFTER PLACEMENT OF THE WEB DEVICE, DETACHMENT WAS INITIATED WITH THE CONTROLLER; HOWEVER, THE WEB MOVED BACK WITH THE DELIVERY WIRE AS IT WAS BEING WITHDRAWN. MULTIPLE ATTEMPTS WERE MADE TO DETACH THE WEB BY MANIPULATING THE DEVICE WITH THE MICROCATHETER, THE DELIVERY WIRE, AND WITH THE DETACHMENT CONTROLLER. AS A RESULT OF THE MANIPULATIONS, THE PROXIMAL PORTION OF THE WEB HERNIATED INTO THE PARENT ARTERY. A STENT WAS DEPLOYED TO ENSURE PROPER PLACEMENT OF THE WEB IN THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10255851 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON AN UNRUPTURED TERMINUS BIFURCATION ANEURYSM IN THE INTERNAL CAROTID ARTERY. AFTER DEPLOYMENT OF THE WEB, AN ANEURYSM RUPTURE AND SLOW BLEED WAS IDENTIFIED. A BALLOON WAS INFLATED AND THE BLEEDING STOPPED. THE PATIENT WAS REPORTED TO BE "AWAKE AND OK" WITH "NO HEADACHE" APPROXIMATELY ONE HOUR AFTER THE PROCEDURE. THE PATIENT IS CURRENTLY REPORTED TO BE DOING "GREAT."

  Patient problems: Rupture

  MAUDE report 9827495 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE 5TH EMBOLIZATION COIL IN AN ANEURYSM, THE COIL WAS NOTED TO EXTEND BEYOND THE CONFINES OF THE ANEURYSM WALL. AFTER THE COIL WAS REPOSITIONED, A PUFF INJECTION REVEALED A SMALL AMOUNT OF CONTRAST EXTRAVASATION. AN OCCLUSION BALLOON WAS INFLATED FOR 5 MINS AND PROTAMINE WAS ADMINISTERED. SUBSEQUENT ANGIOGRAPHY DEMONSTRATED THE COIL WAS WELL SEATED IN THE ANEURYSM AND THE PARENT VESSEL WAS WIDELY PATENT. THERE WAS NO FURTHER EVIDENCE OF EXTRAVASATION. THE EVENT DID NOT LEAD TO ANY UNTOWARD MEDICAL OCCURRENCE IN THE PATIENT OR RESULT IN ANY NEGATIVE CLINICAL OUTCOME.

  Patient problems: Extravasation; Rupture

  MAUDE report 9802993 ↗
• DeathFeb 14, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A RIGHT P-COM ANEURYSM ON A PATIENT UNDER CONSCIOUS SEDATION. AFTER UNEVENTFUL PLACEMENT OF THE WEB, IMAGING DEMONSTRATED A SMALL AMOUNT OF ENCROACHMENT OF THE PARENT VESSEL. DELAYED IMAGING DEMONSTRATED GOOD FLOW WITHIN THE PARENT ARTERY [RIGHT INTERNAL CAROTID (RICA)] AND DECREASED FLOW INTO THE ANEURYSM SAC. THE WEB WAS DETACHED APPROXIMATELY 7 MINUTES AFTER DEPLOYMENT. A SUBSEQUENT NEURO CHECK WAS PERFORMED AND THE PATIENT DEMONSTRATED WEAKNESS OF THE LEFT UPPER EXTREMITY. 3-D RECONSTRUCTION ANGIOGRAPHY DEMONSTRATED REDUCED FLOW IN THE RICA AND WEB MIGRATION FROM THE ANEURYSM SAC INTO THE DISTAL RIGHT MCA-M1 SEGMENT. THERE WAS TOTAL OCCLUSION OF THE RIGHT MCA BRANCHES AND OUTFLOW. ATTEMPTS WERE MADE WITH MULTIPLE DEVICES TO RETRIEVE THE WEB; HOWEVER, ALL EFFORTS WERE UNSUCCESSFUL. A STENT WAS IMPLANTED TO COMPRESS THE WEB AGAINST THE M1 VESSEL, AND IN-STENT BALLOON INFLATIONS WERE PERFORMED; HOWEVER, THERE WAS ONLY SLIGHT INCREASE IN FLOW. THE M1 VESSEL APPEARED TO HAVE A NEW VESSEL DISSECTION WITH ASSOCIATED EXTRAVASATION AT THE SITE OF THE BALLOON INFLATIONS. TEN (10) EMBOLIZATION COILS WERE IMPLANTED TO SACRIFICE THE PARENT VE

  Patient problems: Hemorrhage, Cerebral; Intimal Dissection; Neurological Deficit/Dysfunction; Vascular System (Circulation), Impaired

  MAUDE report 9714819 ↗