WEB Aneurysm Embolization System W4-6-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00854111006099), received between Apr 24, 2019 and Mar 12, 2020 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• DeathApr 24, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH THE WEB DEVICE, THE ANEURYSM RUPTURED. AS REPORTED, THERE WAS NO DIFFICULTY ADVANCING THE CATHETER OR WEB DEVICE. THERE WAS NOTED ANGULATION BETWEEN THE ANEURYSM AND THE VESSEL. DURING DEPLOYMENT OF THE WEB DEVICE WITHIN THE SAC, THE PHYSICIAN STARTED TO UNSHEATHE THE WEB DEVICE, THE SYSTEM MOVED PROXIMALLY TOWARD THE NECK AND THE WEB WAS PARTIALLY DEPLOYED. IT WAS NOTED THAT THE WEB WAS NOT DEPLOYING AS EXPECTED AND A SUBSEQUENT CONTRAST INJECTION DEMONSTRATED EXTRAVASATION AT THE NECK OF THE ANEURYSM. THE WEB WAS RETRACTED AND REMOVED TOGETHER WITH THE VIA MICROCATHETER. A SCEPTER BALLOON WAS ADVANCED AND PLACED TO OCCLUDE THE ANEURYSM, AND A VENTRICULAR SHUNT WAS PLACED. ONCE THE BLEEDING WAS CONTROLLED, THE PROCEDURE WAS COMPLETED WITH BALLOON-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM. IMMEDIATELY FOLLOWING THE PROCEDURE, A CT WAS PERFORMED, AND THE PATIENT WAS TAKEN BACK TO THE OR FOR ADDITIONAL PLACEMENT OF A VENTRICULAR SHUNT. PATIENT STATUS WAS UNKNOWN AT THE TIME OF THE REPORT.

  Patient problems: Death; Hemorrhage, Subarachnoid; Neurological Deficit/Dysfunction; Rupture

  MAUDE report 8545775 ↗

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.