WEB Aneurysm Embolization System W4-4-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00854111006044), received between Jun 14, 2019 and Mar 24, 2021 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryFeb 3, 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 ANTERIOR COMMUNICATING ARTERY (PERICALLOSAL) ANEURYSM. THE PATIENT HAD NOT BEEN GIVEN ANTICOAGULANT MEDICATION BEFORE THE PROCEDURE. A POST-DEPLOYMENT ANGIOGRAM DEMONSTRATED NORMAL FLOW IN THE A-COM ARTERY; HOWEVER, A CLOT WAS IDENTIFIED AT THE NECK OF THE ANEURYSM AND ON THE WEB DEVICE. A BOLUS OF INTEGRILIN WAS ADMINISTERED AND FULL FLOW WAS RESTORED. THERE WAS NO REPORTED CLINICAL SEQUELA.

  Patient problems: Thrombus

  MAUDE report 9662629 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WEB DEVICE WAS BEING USED TO TREAT AN ANEURYSM THAT CAME OFF THE ANTERIOR COMMUNICATING ARTERY (ACOM) AT AN APPROXIMATE 45-DEGREE ANGLE. THE A-1 WAS STRAIGHT, BUT THERE WAS SOME PROXIMAL TORTUOSITY. THE WEB WAS ADVANCED INTO THE ANEURYSM AND DURING DEPLOYMENT, IT BECAME APPARENT THE ANEURYSM RUPTURED; HOWEVER, THE EXACT LOCATION OF THE RUPTURE WAS UNKNOWN. THE WEB WAS DEPLOYED IN THE A-1 TO CAUSE STASIS AND ESSENTIALLY ACTED AS A BALLOON, ELIMINATING FLOW TO THE RUPTURE SITE. THE WEB WAS RESHEATHED AND A SUBSEQUENT CONTRAST INJECTION WAS PERFORMED TO IDENTIFY THE RUPTURE SITE, WHICH WAS DETERMINED TO BE AT THE DOME OF THE ANEURYSM AT THE SHALLOWEST PART. THE WEB WAS THEN ADVANCED UP TO THE NECK OF THE ANEURYSM AND DEPLOYED PARTIALLY UNTIL THE DISTAL END WAS FLOWERED AND ATRAUMATIC, THE ENTIRE SYSTEM WAS MOVED FORWARD UNTIL THE WEB WAS IN THE ANEURYSM, AND THEN IT WAS COMPLETELY DEPLOYED. THE WEB PARTIALLY IMPINGED ON BOTH A-2S, ONE ABOUT 20% AND ONE APPROXIMATELY 70%. NO FURTHER INTERVENTION WAS PERFORMED. FOLLOWING THE PROCEDURE, THE PATIENT HAD SOME SIGNIFICANT NEUROLOGICAL DEFICITS, BUT CONTINUED TO IMPROVE EVERY DAY. THE PATIENT CURRENTLY IS ESSENTIALLY

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

  MAUDE report 8702160 ↗

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.