Wingspan M003WS0400150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540722867), received between Feb 22, 2017 and Aug 13, 2018 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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

• MalfunctionAug 13, 2018Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE STENT DELIVERY WIRE BROKE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7779199 ↗
• DeathFeb 22, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation 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 WAS ATTEMPTED TO BE IMPLANTED BUT COULD NOT BE DEPLOYED BEYOND THE POORLY OPENED DISTAL TINES OF THE FIRST DEPLOYED STENT. A THIRD STENT (SUBJECT DEVICE) 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. THERE WAS SOME BENDING OF THE HYPOTUBE BUT IT DID NOT RENDER THE STENT UNUSABLE. BLOOD FLOW WAS N

  Patient problems: Coma; Death

  MAUDE report 6351667 ↗