Wingspan M003WS0450200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540722904), received between Jun 6, 2018 and Feb 9, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionFeb 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN WAS ADVANCING THE SUBJECT WINGSPAN STENT SYSTEM OVER THE WIRE AND HE FOUND THE STABILIZER OF THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304955 ↗
• InjuryMar 29, 2019Break; Migration; Break; Migration

  IT WAS REPORTED THAT DURING TREATMENT A BASILAR ARTERY STENOSIS WITH A BALLOON AND THE SUBJECT DEVICE STENT SYSTEM, THE SUBJECT DEVICE STENT WAS SUCCESSFULLY DEPLOYED AND EXPANDED, BUT UPON RETRIEVAL OF ITS DELIVERY SYSTEM, SOMETHING MUST HAVE GRABBED THE PROXIMAL PORTION OF THE DEPLOYED STENT. WHEN THE SUBJECT DEVICE STENT SYSTEM CATHETERS WERE REMOVED, THE SYSTEM "JUMPED" (I.E. RELEASED ENERGY), AND UPON REMOVAL FROM THE BODY, SHOWED THAT PART OF THE SUBJECT DEVICE STENT HAD BROKEN IN HALF AND WAS REMOVED FROM THE BODY WITH THE CATHETER SYSTEM. THE REST OF THE SUBJECT DEVICE STENT REMAINED IMPLANTED IN THE PATIENT'S BASILAR ARTERY. IN ORDER TO ENSURE THE SUBJECT DEVICE STENT WAS OPPOSING THE WALLS WITHIN THE PATIENT'S BASILAR ARTERY, THE PHYSICIAN THEN TRACKED A MICROCATHETER THROUGH THE LUMEN OF THE STENT IN THE BASILAR AND PROCEEDED TO DEPLOY TWO ANOTHER STENTS INSIDE THE PATIENT'S BASILAR ARTERY. THE PATIENT'S ANGIOGRAPHIC RESULTS LOOKED SATISFACTORY POST-DEPLOYMENT, AND THE PATIENT SHOWED NO ADVERSE CLINICAL EVENTS FROM THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466955 ↗
• InjuryJun 6, 2018Premature Activation; Premature Activation

  MEDWATCH REPORT (MW5076912) WAS RECEIVED FROM THE FDA ON MAY 21, 2018. IT WAS REPORTED THAT THE PATIENT WENT UNDER GENERAL ANESTHESIA FOR ANGIOPLASTY PROCEDURE TO TREAT STENOSIS AT LEFT INTERNAL CAROTID ARTERY (LICA). DURING PROCEDURE, THE PHYSICIAN TRIED TO EXCHANGE THE BALLOON CATHETER WITH THE SUBJECT STENT DELIVER SYSTEM. DURING THE EXCHANGE, THE CUSTOMER NOTICE THAT THE SUBJECT STENT BECAME UN-SHEATHED AND WAS NOT ABLE TO PULL THE STENT BACK INTO THE SHEATH. THE PHYSICIAN DECIDED TO DEPLOY THE SUBJECT STENT IN THE DISTAL VERTICAL SEGMENT OF THE PETROUS TO AVOID DAMAGING THE VESSEL. THE DELIVERY SYSTEM WAS THEN EXCHANGE AND NEW STENT WAS DEPLOYED SUCCESSFULLY IN THE HORIZONTAL PETROUS SEGMENT TO COMPLETE THE PROCEDURE. THE POST-SURGICAL ANGIOGRAM SHOWED LESS THAN 50% RESIDUAL. NO THROMBUS OR DISSECTION WERE OBSERVED. THERE WERE NO REPORTED CLINICAL PATIENT COMPLICATIONS DUE TO THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7576418 ↗