Wingspan M003WS0300090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540722799), received between Jul 1, 2016 and May 4, 2022 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionMay 4, 2022Fracture; Premature Activation; Fracture; Premature Activation

  IT WAS REPORTED THAT DURING PROCEDURE AT M1 TREATMENT SITE, DURING DEPLOYMENT OF THE STENT (SUBJECT DEVICE), THE CUSTOMER FELT FRICTION WHILE TRYING TO PUSH THE HYPO TUBE INTO THE OUTER BODY OF THE DEVICE (RESISTANCE FELT WHEN TRYING TO DEPLOY THE STENT BY PULLING BACK THE OUTER BODY). AT ONE POINT, THE HUB OF THE OUTER BODY BROKE OFF THE CATHETER AND THE CATHETER APPEARED TO BE STRETCHED IN ONE SEGMENT OF THE CATHETER. THE CUSTOMER OPTED TO PULL THE DEVICE OUT BUT THAT INADVERTENTLY DEPLOYED THE STENT (SUBJECT DEVICE). HOWEVER, THE STENT (SUBJECT DEVICE) WAS DEPLOYED AT THE CORRECT POSITION THAT HE WANTED THE STENT TO DEPLOY. HE THEN CAREFULLY PULLED THE SYSTEM OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE. AFTER PULLING THE SYSTEM OUT, WE NOTICED THE HUB OF THE OUTER BODY HAD BROKEN OFF AND NOTICED THE STRETCHING OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274949 ↗
• MalfunctionDec 12, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE DURING STENT (SUBJECT DEVICE) DEPLOYMENT DURING THE PROCEDURE AND UPON REMOVAL, THE STENT DETACHED PREMATURELY INSIDE THE GUIDE CATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8158539 ↗
• DeathJul 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING ANGIOPLASTY AND STENTING PROCEDURE FOR LEFT MIDDLE CEREBRAL ARTERY (MCA) STENOSIS, THE PATIENT'S CONDITION WAS STABLE AND AT NEUROLOGICAL BASELINE. APPROXIMATELY 18 HOURS POST PROCEDURE, HEMORRHAGE OCCURRED IN THE LEFT MCA TERRITORY. DECOMPRESSIVE CRANIECTOMY WAS ATTEMPTED BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT. THE EVENT WAS NOT RESOLVED AND EVALUATED BY PHYSICIAN TO BE A SERIOUS INJURY. PATIENT'S CONDITION WORSENED AND PATIENT EXPIRED 8 DAYS AFTER PROCEDURE. THE PHYSICIAN CONSIDERED THE ADVERSE EVENT AND SUBSEQUENT DEATH UNRELATED TO THE DEVICE. OTHER POSSIBLE CONTRIBUTING FACTORS TO THE EVENT WERE HYPERTENSION.

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 5765194 ↗