Wingspan M003WS0300150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540722805), received between Aug 4, 2016 and Mar 30, 2020 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE PUSHER WIRE OF THE STENT DELIVERY SYSTEM (SUBJECT DEVICE) MAY HAVE BROKEN OR BENT INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9899220 ↗
• MalfunctionAug 14, 2019Break; Break

  IT WAS REPORTED THE STENT INNER BODY BROKE INSIDE THE PATIENT. THERE WAS NO CLINICAL CONSEQUENCE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893844 ↗
• MalfunctionAug 13, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THE STENT (SUBJECT DEVICE) PREMATURELY DEPLOYEDINSIDE THE PATIENT. THERE WAS NO WAS NO CLINICAL CONSEQUENCE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890714 ↗
• MalfunctionOct 11, 2017Break; Break

  IT WAS REPORTED THAT THE INNER BODY TIP ON THE STENT STABILIZER SYSTEM SEPARATED UPON WITHDRAWAL OF SYSTEM AFTER STENT DEPLOYMENT. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6942624 ↗
• InjuryApr 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A NEURO STENTING (SUBJECT DEVICE) SURGICAL PROCEDURE TO PLACE A STENT IN THE LICA (LEFT INTERNAL CAROTID ARTERY) AND LMCA (LEFT MIDDLE CEREBRAL ARTERY). IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT SUFFERED FROM A LARGE LEFT MCA STROKE. FURTHER HOSPITALIZATION OF THE PATIENT WAS COMPLICATED BY ASPIRATION RESULTING IN MDR (MULTIDRUG-RESISTANT) PNEUMONIA WITH ACUTE HYPOXIC FAILURE AND ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME) REQUIRING INTUBATION. THE PATIENT ALSO DEVELOPED A LOWER GI (GASTROINTESTINAL) BLEED. IN ADDITION, THE LICA/MCA STENTED AREAS WENT ON TO OCCLUDE AND A PONTINE INTRACEREBRAL HEMORRHAGE ALSO OCCURRED. IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO CARDIOPULMONARY ARREST APPROXIMATELY 17 DAYS POST THE INDEX PROCEDURE. THE PHYSICIAN HAS STATED THAT THE STENT(S) DID NOT MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 6519945 ↗
• InjuryOct 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING ANGIOPLASTY WITH THE BALLOON CATHETER, A STENT (SUBJECT DEVICE) WAS PLACED ACROSS THE 76% STENOSED RIGHT MIDDLE CEREBRAL ARTERY (MCA) M1 LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE IMPROVEMENT IN THE LUMINAL DIAMETER. POST PROCEDURE, THE FOLLOWING DAY THE PATIENT COMPLAINED OF DIFFICULTY LIFTING LEFT LOWER EXTREMITY FROM BED. THE PHYSICIAN ASSESSED THE PATIENT¿S ABILITY TO LIFT THE LEFT LEG AND THE STRENGTH OF THE LEG AS 4+. THE FLUID BOLUS (UNSPECIFIED) WAS ADMINISTERED TO TREAT THE PATIENT. THIS EVENT WAS RESOLVED WITHOUT ANY RESIDUAL EFFECT. THE PATIENT WAS DISCHARGED HOME WITH THE MODIFIED RANKIN SCALE (MRS) SCORE OF 0. AS PER THE PHYSICIAN¿S OPINION THE PATIENT¿S OUTCOME IS RELATED TO THE PROCEDURE HOWEVER IT IS UNKNOWN IF IT IS RELATED TO THE DEVICE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 6054377 ↗
• MalfunctionAug 4, 2016Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE STENT HAD PREMATURELY DEPLOYED DURING USE. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5848394 ↗