WEB Aneurysm Embolization System W4-7-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00854111006136), received between Sep 14, 2019 and Jan 9, 2021 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 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. How this data works · Data updated Oct 13, 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.

• 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 ↗
• 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 ↗
• InjurySep 14, 2019Difficult or Delayed Positioning; Difficult to Fold, Unfold or Collapse; Difficult or Delayed Positioning; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT TREATMENT WAS ATTEMPTED ON AN ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM) WHICH HAD AN ACUTE TAKEOFF ANGLE FROM THE PARENT ARTERY. AFTER MULTIPLE ATTEMPTS, THE MICROCATHETER FINALLY GAINED ACCESS TO THE ANEURYSM FROM THE RIGHT INTERNAL CAROTID ARTERY (ICA); HOWEVER, THE WEB DEVICE WAS NOT OPENING ADEQUATELY, DESPITE SEVERAL DEPLOYMENT ATTEMPTS. THE MICROCATHETER AND WEB DEVICE WERE REMOVED. A NEW VIA 21 MICROCATHETER WAS SUCCESSFUL AT OBTAINING ACCESS TO THE ANEURYSM FROM THE LEFT ICA. DEPLOYMENT OF THE SAME WEB DEVICE WAS ATTEMPTED, BUT EFFORTS WERE UNSUCCESSFUL DUE TO DIFFICULT ANATOMY. DURING PARTIAL DEPLOYMENT OF THE WEB, A NEW ROADMAP IMAGE WAS OBTAINED, WHICH DEMONSTRATED AN ANEURYSM RUPTURE WITH CONTRAST EXTRAVASATION. THE WEB DEVICE WAS REMOVED AND THE ANEURYSM WAS PARTIALLY COILED THROUGH THE VIA MICROCATHETER, WHICH WAS EFFECTIVE AT CONTROLLING THE BLEEDING; HOWEVER, CHANGES IN THE PATIENT'S VITAL SIGNS WERE INDICATIVE OF A SUBARACHNOID HEMORRHAGE. THE ANEURYSM TREATMENT WAS STOPPED AT THIS POINT SO THAT AN EVD COULD BE PLACED. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. THE PATIENT IS REPORTED TO HAVE RECOVERED AND THE ANEURYSM WAS RETREATE

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 9056928 ↗

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.