Wingspan M003WS0350200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540722843), received between May 23, 2016 and Nov 25, 2020 — classified as 1 death, 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF STENOTIC MCA (MIDDLE CEREBRAL ARTERY) WITH 80% STENOSIS AND CALCIFICATION AT THE LESION, AFTER ADVANCEMENT OF THE STENT DELIVERY SYSTEM (SUBJECT DEVICE)THROUGH TORTUOUS ANATOMY TO THE LESION, WHILE THE STENT DELIVERY SYSTEM WAS ATTEMPTING TO UNSHEATH THE STENT DURING DEPLOYMENT THE HYPOTUBE (STENT STABILIZER) SNAPPED OFF AT THE HUB OF MICROCATHETER OUTSIDE THE PATIENT VASCULATURE. WITH THE STABILIZER UNABLE TO DEPLOY THE STENT, THE SYSTEM WAS REMOVED FROM THE GUIDE CATHETER WITHOUT ANY ISSUES. ACCORDING TO PHYSICIAN VESSEL TORTUOSITY OF INTENDED AREA OF TREATMENT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901832 ↗
• 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 (SUBJECT DEVICE) WAS PERFORMED. HOWEVER, THE DISTAL STENT TINES DID NOT OPEN PROPERLY EVEN WITH ADDITIONAL ANGIOPLASTY PROCEDURE. BLOOD FLOW WAS NOT RESTORED. THE PHYSICIAN STATED THAT HE ¿DID NOT UNDERSTAND THE FAILURE OF THE TINES TO OPEN. PERHAPS HEMATOMA FROM THE VESSEL INJURY AFTER THE BALLOON INFLATION IMPACTED THIS¿. A SECOND STENT WAS ATTEMPTED TO BE IMPLANTED BUT COULD NOT BE DEPLOYED BEYOND THE POORLY OPENED DISTAL TINES OF THE FIRST DEPLOYED STENT (SUBJECT DEVICE). A THIRD STENT WAS DEPLOYED MORE DISTALLY IN THE BASILAR ARTERY AND OVERLAPPING THE OR

  Patient problems: Coma; Death

  MAUDE report 6351664 ↗
• InjuryMay 23, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT POST STENT DEPLOYMENT, THE INNER BODY TAPERED TIP OF THE STENT DELIVERY SYSTEM, GOT CAUGHT WITH THE STENT. AS THE STENT DELIVERY SYSTEM WAS BEING PULLED BACK, THE STENT STARTED TO MOVE. THE PHYSICIAN ADVANCED AN INTERMEDIATE CATHETER OVER THE STENT DELIVERY SYSTEM SUCCESSFULLY RELEASING THE INNER BODY TAPERED TIP FROM THE STENT WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5672849 ↗