WEB Aneurysm Embolization System W4-5-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854111006013), received between Nov 8, 2019 and Nov 8, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Retraction Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathNov 8, 2019Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE VESSEL WAS REPORTED TO BE TORTUOUS. AN ATTEMPT WAS MADE TO RETRACT THE WEB DEVICE INTO THE VIA MICROCATHETER FOR REPOSITIONING IN THE ANEURYSM. ADDITIONAL FORCE WAS REQUIRED TO RECAPTURE THE WEB INTO THE VIA DUE TO THE VESSEL TORTUOSITY AND THE ANGLE OF THE MICROCATHETER IN RELATION TO THE PROXIMAL MARKER OF THE WEB DEVICE. AT THE TIME THE WEB WAS WITHDRAWN INTO THE VIA, THE VIA "JUMPED" FORWARD. THE MICROCATHETER WAS PULLED BACK AND AN ANGIOGRAPHY RUN DEMONSTRATED CONTRAST EXTRAVASATION FROM THE ANEURYSM. HEPARIN WAS REVERSED AND PROTAMINE WAS ADMINISTERED. THE VIA AND WEB WERE REMOVED TOGETHER, A NEW MICROCATHETER WAS PLACED, AND THREE (3) EMBOLIZATION COILS WERE IMPLANTED IN THE ANEURYSM, WHICH STOPPED THE BLEEDING; HOWEVER, THE PATIENT DEVELOPED INTRACRANIAL HYPERTENSION DURING THE PROCEDURE, AND BOTH PUPILS WERE NOTED TO BE DILATED AND UNRESPONSIVE. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED AND THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT NEVER REGAINED CONSCIOUSNESS AND DIED FOUR DAYS LATER. THE CAUSE OF DEATH WAS DETERMINED BY THE PHYSICIAN TO BE "HIGH INTRACRA

  Patient problems: Death; Hemorrhage, Cerebral; Rupture

  MAUDE report 9298617 ↗

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.