WEB Aneurysm Embolization System W4-5-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00854111006068), received between Mar 28, 2019 and Aug 14, 2020 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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DETACHMENT WAS INITIATED WITH THE CONTROLLER; HOWEVER, THE WEB MOVED BACK WITH THE DELIVERY WIRE AS IT WAS BEING WITHDRAWN.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 ↗
• InjuryOct 27, 2019Difficult to Remove; Separation Failure; Device Dislodged or Dislocated; Difficult to Remove; Separation Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A SUBARACHNOID HEMORRHAGE OF THE RIGHT MCA. THE WEB DEVICE WAS POSITIONED IN THE ANEURYSM THROUGH A VIA MICROCATHETER. THREE UNSUCCESSFUL ATTEMPTS WERE MADE TO DETACH THE WEB AND ON THE 4TH ATTEMPT, THE WEB DETACHED WITH SLIGHT ADVANCEMENT OF THE VIA. AT THE TIME OF THE DETACHMENT, THERE WAS A SLIGHT PROXIMAL MOVEMENT OF THE WEB. FOLLOW-UP ANGIOGRAPHY AND CT IMAGES SHOWED SLIGHT ROTATION OF THE WEB AND A SLIGHT FLOW DELAY IN THE M2. ATTEMPTS WERE MADE TO REPOSITION THE WEB BACK INTO THE ANEURYSM WITH THE VIA; HOWEVER, THE WEB APPEARED TO ROTATE MORE WITHIN THE ANEURYSM AND THE M2 HAD GREATER DELAYED FLOW. THE M2 APPEARED TO BE OCCLUDED APPROXIMATELY 90% AND A WIRE COULD NOT BE PASSED THROUGH IT. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE WEB WITHOUT SUCCESS, SO THE PROCEDURE WAS ABORTED. THE PATIENT AWOKE WITH LEFT SIDED WEAKNESS OF THE UPPER AND LOWER LIMBS AND HEMINEGLECT. POST-OPERATIVE CT IMAGING CONFIRMED THE PATIENT HAD A STROKE DUE TO OCCLUSION OF THE SUPERIOR M2, AND THE POSITION OF THE WEB WAS STABLE WITH NO FILLING IN THE ANEURYSM. THE WEB APPEARED TO BE PROTRUDING SOMEWHAT INTO THE M2. TWO DAYS AFTER THE PROCEDURE, THE PATIE

  Patient problems: Neurological Deficit/Dysfunction; Vascular System (Circulation), Impaired

  MAUDE report 9243350 ↗
• DeathJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE MICROCATHETER WAS ADVANCED TO THE TREATMENT SITE AND THE WEB WAS PARTIALLY DEPLOYED WITHIN THE ANEURYSM. THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE WEB WAS SITTING, SO THE WEB WAS RESHEATHED AND AN ATTEMPT WAS MADE TO REPOSITION IT IN THE ANEURYSM. AT THAT TIME, IT WAS OBSERVED THAT THE PATIENT'S BLOOD PRESSURE HAD SPIKED. A CONTRAST INJECTION DEMONSTRATED THE ANEURYSM HAD RUPTURED. A BALLOON CATHETER WAS USED TO STOP THE BLEEDING. MULTIPLE COILS (NON-MICROVENTION) WERE SUBSEQUENTLY PLACED IN THE ANEURYSM AND AN EVD WAS PLACED. BLEEDING WAS CONTROLLED AND THE PATIENT WAS TAKEN TO THE ICU POST-OP. IT WAS LATER REPORTED THAT THE PATIENT HAD EXPIRED THREE (3) DAYS POST-PROCEDURE. SUBARACHNOID HEMORRHAGE WAS NOTED TO BE THE CAUSE OF DEATH. THE PHYSICIAN STATED THERE WAS NO MALFUNCTION OF THE WEB DEVICE.

  Patient problems: Death; Hemorrhage, Subarachnoid; Rupture

  MAUDE report 8719259 ↗
• InjuryMar 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TREATMENT WAS BEING PERFORMED FOR AN UNRUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM. ACCESS TO THE TREATMENT SITE AND POSITIONING OF THE WEB IN THE ANEURYSM WERE ACCOMPLISHED WITHOUT INCIDENT. AFTER PLACEMENT OF THE WEB, THERE WAS DIFFICULTY MAINTAINING THE PATIENT'S AIRWAY, AND IT APPEARED THAT THE LEFT LUNG HAD COLLAPSED. THE WEB WAS DETACHED, AND FOLLOW-UP ANGIOGRAPHY CONFIRMED PROPER PLACEMENT. NO CONTRAST EXTRAVASATION WAS NOTED AT THAT TIME. THE PROCEDURE WAS PAUSED FOR SEVERAL MINUTES TO MANAGE THE PATIENT'S AIRWAY. UPON RESUMING THE PROCEDURE, ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION FROM THE ANEURYSM. A SCEPTER OCCLUSION BALLOON WAS PLACED AND INFLATED AT THE NECK OF THE ANEURYSM FOR APPROXIMATELY 3 MINUTES, OCCLUDING THE ANEURYSM. DURING DEFLATION OF THE BALLOON, IT APPEARED THAT THE WEB SHIFTED POSITION, OCCLUDING TWO MCA M2 DIVISIONS; THEREFORE, AN ATLAS STENT WAS IMPLANTED ACROSS THE NECK OF THE ANEURYSM TO SECURE THE WEB IN THE ANEURYSM TO ALLOW THE MCA BRANCHES TO REMAIN PATENT. THE PROCEDURE WAS COMPLETED WITH SATISFACTORY PLACEMENT OF THE WEB AND NO EVIDENCE OF ACTIVE EXTRAVASATION. POST-PROCEDURE MRA WAS PERFORMED IMMEDIATELY AFTER THE PROC

  Patient problems: Rupture; Vascular System (Circulation), Impaired

  MAUDE report 8462772 ↗

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.