Wingspan M003WS0350150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540722836), received between Aug 4, 2016 and Apr 10, 2019 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Premature Activation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY AND STENTING WITH THE SUBJECT STENT OF A HIGH-GRADE LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT INTRACRANIAL STENOSIS WITH RECURRENT STROKES. APOST-PROCEDURE THE PATIENT CONDITION WAS STABLE. THREE HOURS POST-PROCEDURE, THE PATIENT DEVELOPED STROKE SYMPTOMS (EXPRESSIVE APHASIA, RUE (RIGHT UPPER EXTREMITY), RLE (RIGHT LOWER EXTREMITY), WEAKNESS, RIGHT FACIAL DROOP). COMPUTED TOMOGRAPHY (CT) HEAD WAS DONE WHICH DEMONSTRATED A LARGE LEFT FRONTAL LOBE INTRAPARENCHYMAL HEMORRHAGE AND A LEFT FRONT-TEMPORAL SUBARACHNOID HEMORRHAGE CAUSING MASS EFFECT AND A 5MM RIGHTWARD MIDLINE SHIFT. THE PATIENT RECEIVED DDAVP (DESMOPRESSIN) AND PLATELET TRANSFUSION, WAS BROUGHT TO OPERATING ROOM, HAD DECOMPRESSIVE CRANIECTOMY AND DECOMPRESSION OF THE HEMATOMA.

  Patient problems: Hematoma; Hemorrhage, Cerebral; Hemorrhage, Subarachnoid; Stroke/CVA

  MAUDE report 8502228 ↗
• DeathAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED FOR SLURRED SPEECH AND RIGHT-SIDED WEAKNESS, GAIT DIFFICULTY. MRI SCAN REVEALED SUBACUTE-LOOKING LEFT MEDIAL PONTINE INFARCT. THE PATIENT UNDERWENT ANGIOPLASTY AND THEN PLACEMENT OF A FIRST STENT SYSTEM. THEREAFTER AN OVERLAPPING 2ND STENT (SUBJECT DEVICE) WAS PLACED. POST DILATION WAS PERFORMED. FINAL PROJECTION DEMONSTRATED GOOD STENT APPOSITION. NO RESIDUAL STENOSIS AND EXCELLENT FLOW TO DISTAL VESSELS. AFTER PROCEDURE, MRI REVEALED LEFT PONS INFARCTION. THERE WAS EVIDENCE OF EXPANDING PONTINE INFARCT OVER THE TIME. NEUROLOGICALLY, ON EXAMINATION, IT APPEARED THAT THE PATIENT HAD A LOCKED -IN SYNDROME AND REMAINED ON MECHANICAL VENTILATOR. HE CONTINUED A CARDENE DRIP. HE COULD NOT BE ANTICOAGULATED BECAUSE OF THE BRAIN INJURY. ULTIMATELY, THERE WAS EVIDENCE OF MULTIPLE EMBOLIC STROKES INVOLVING THE CEREBELLUM AND CEREBRUM. THE PATIENT DEVELOPED CEREBRAL EDEMA AND THEN BRAINSTEM HERNIATION. ALONG WITH THAT. HE DEVELOPED HYPERGLYCEMIA, ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND NEUROGENIC SHOCK. THE PATIENT DIED 5 DAYS POST PROCEDURE. THE PHYSICIAN ASSESSED THAT THE ADVERSE EVENTS WERE UNLIKELY TO BE RELATED TO THE SUBJECT DEVICE. THE OTHER POSSIBLE CO

  Patient problems: Death; Hyperglycemia; Neurogenic Shock; Respiratory Distress; Stroke/CVA

  MAUDE report 7827854 ↗
• InjurySep 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST ELECTIVE CLIPPING OF AN ANTERIOR CHOROIDAL ARTERIAL ANEURYSM, THE PATIENT WAS TREATED FOR THE LEFT INTERNAL CAROTID ARTERY (ICA) STENOSIS (OPHTHALMIC SEGMENT) BY 4 BALLOON ANGIOPLASTY. THE SECOND ANGIOPLASTY WITH A NON-STRYKER DEVICE WAS COMPLICATED WITH AN ENDOTHELIAL DISSECTION OF THE DISTAL LEFT OPHTHALMIC SEGMENT OF THE ICA. THE STENT (SUBJECT DEVICE) WAS UNEVENTFULLY PLACED TO TREAT THE DISSECTION AND THE STENOSIS AT THE STENOTIC SEGMENT. HOWEVER, IN-STENT THROMBOSIS WITH 2 FOCI OF DISTAL THROMBOEMBOLISM OCCURRED. PLATELET AGGREGATION INHIBITOR (ABCIXIMAB) WAS ADMINISTERED BUT IN-STENT THROMBOSIS WAS PERSISTENT. ANTICOAGULANT (HEPARIN) WAS ADMINISTERED AND IN-STENT THROMBOSIS WAS IMPROVED. IT WAS REPORTED THAT IN-STENT THROMBOSIS ADVERSE EVENT WAS RESOLVED WITHOUT CLINICAL CONSEQUENCES. POST PROCEDURE, THE PATIENT HAD HEMIPARESIS, WHICH WAS BELIEVED MOST LIKELY DUE TO DISSECTION.

  Patient problems: Thrombosis

  MAUDE report 5964372 ↗
• MalfunctionAug 4, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING PROCEDURE AT THE BASILAR ARTERY, THE SUBJECT STENT WAS UNINTENTIONALLY DEPLOYED PREMATURELY INSIDE THE MICROCATHETER ¾ OF THE WAY IN AND WAS LEFT INSIDE THE MICROCATHETER. A SECOND STENT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5848386 ↗