Wingspan M003WS0400200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540722874), received between May 27, 2016 and Jun 9, 2017 — classified as 2 deaths, 1 injury.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT UNEVENTFUL STENTING OF THE PETROUS SEGMENT LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. IT WAS REPORTED THAT FOUR DAYS POST PROCEDURE, THE PATIENT DEVELOPED TRANSIENT ISCHEMIC ATTACK (TIA). NO TREATMENT WAS REQUIRED AND THE EVENT RESOLVED WITHOUT ANY RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED APPROXIMATELY THREE DAYS LATER ASSESSED HAVING AN MRS OF 1. RELATIONSHIP OF THE DEVICE PERFORMANCE TO THE TIA WAS REPORTED AS UNKNOWN. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "PRETTY GOOD".

  Patient problems: Transient Ischemic Attack

  MAUDE report 6631047 ↗
• DeathFeb 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS PRESENTED IN A LIFE-THREATENING CONDITION WITH A BASILAR THROMBOTIC STROKE AND NEUROLOGICAL DEFICIT. ACCESS TO THE CLOT WAS LIMITED TO THE RIGHT VERTEBRAL ARTERY (VA) THAT PRESENTED A CRITICAL STENOSIS OF THE VA-DISTAL V4 SEGMENT. LEFT VERTEBRAL ARTERY WAS OCCLUDED AND NOT ACCESSIBLE. ANGIOPLASTY WITH A BALLOON CATHETER OF THE STENOSIS OF VA-V4 SEGMENT LED TO DISSECTION RESULTANT IN HEMATOMA AND OCCLUSION. MEDICAL INTERVENTION IN ORDER TO RESTORE BLOOD FLOW THROUGH THE OCCLUDED VA- V4 SEGMENT BY ANGIOPLASTY WAS PERFORMED WITHOUT SUCCESS. THEN, STENTING OF THE VA-V4 SEGMENT WITH A FIRST STENT WAS PERFORMED. HOWEVER, THE DISTAL STENT TINES DID NOT OPEN PROPERLY EVEN WITH ADDITIONAL ANGIOPLASTY PROCEDURE. BLOOD FLOW WAS NOT RESTORED. A SECOND STENT (SUBJECT DEVICE) WAS ATTEMPTED TO BE IMPLANTED BUT COULD NOT BE DEPLOYED BEYOND THE POORLY OPENED DISTAL TINES OF THE FIRST DEPLOYED STENT. ATTEMPTS TO PUSH THE STENT RESULTED IN ACUTE BENDING OF THE HYPOTUBE RENDERING THE STENT UNUSABLE. A THIRD STENT WAS DEPLOYED MORE DISTALLY IN THE BASILAR ARTERY AND OVERLAPPING THE ORIGINAL STENT. THE STENT WAS ONLY PLACED WITH GREAT DIFFICULTY THROUGH THE FIRST STENT

  Patient problems: Coma; Death

  MAUDE report 6351670 ↗
• DeathMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING BALLOON ANGIOPLASTY, A STENT (SUBJECT DEVICE) WAS IMPLANTED TO TREAT A 96% STENOSED M1 MIDDLE CEREBRAL ARTERY (MCA) LESION. APPROXIMATELY 6 HOURS POST PROCEDURE, IT WAS NOTED THAT THE PATIENT MENTAL STATUS CHANGED. COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THAT A MASSIVE CEREBRAL HEMORRHAGE RESULTED IN A STROKE WITH SUBSEQUENT BRAIN MIDLINE SHIFT OCCURRED, WHICH LED THE FOLLOWING DAY TO THE PATIENT'S DEATH.

  Patient problems: Death; Hemorrhage, Cerebral; Stroke/CVA

  MAUDE report 5686969 ↗