Wingspan M003WS0250200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540722782), received between Sep 18, 2017 and Jun 30, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE ANGIOPLASTY PROCEDURE FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE TREATMENT OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) PHYSICIAN USED THE SUBJECT STENT. HE TRIED TO INSERT THE DELIVERY CATHETER OF THE SUBJECT STENT AND WAS UNABLE TO ADVANCE IT INTO THE RHV. EVENTUALLY HE HAD TO USE AN OFF-LABEL STENT AS A MEDICAL INTERVENTION TO TREAT THE PATIENT. THE SURGERY WAS DELAYED FOR 20 MINUTES. PROCEDURE WAS NOT COMPLETED AS PHYSICIAN WANTED AND HAS TO USE A DIFFERENT STENT TO TREAT THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14868469 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT STENT ASSISTED BALLOON ANGIOPLASTY OF THE BASILAR TRUNK ARTERY STENOSIS WITH THE SUCCESSFUL IMPLANTATION OF THE FIRST STENT (SUBJECT DEVICE). IT WAS REPORTED THAT THE SECOND STENT DELIVERY SYSTEM WAS UNABLE TO REACH THE TARGET LESION DUE TO SEVERE TORTUOUS ANATOMY AND THE SECOND STENT WAS NOT IMPLANTED. THE NEXT DAY OF THE PROCEDURE, TRACE AMOUNT OF SUBARACHNOID HEMORRHAGE WITHIN INTERPEDUNCULAR AND PREPONTINE CISTERN WAS OBSERVED . THE HEMORRHAGE WAS RESOLVED WITHOUT ANY RESIDUAL EFFECTS. NO TREATMENT WAS ADMINISTERED IN THE PHYSICIAN¿S OPINION, THE CAUSE OF THE HEMORRHAGE IS RELATED TO THE PROCEDURE; HOWEVER, RELATIONSHIP TO THE STENT AND THE BALLOON IS UNKNOWN.

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 6874420 ↗