Wingspan M003WS0350090Recalls & reported problems
Stryker Corporation · Stent System · Class f · Implant
All models of Wingspan (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540722829), received between Oct 4, 2018 and Oct 4, 2018 — classified as 1 death.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
- Hyperglycemia1
- Neurogenic Shock1
- Respiratory Distress1
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathOct 4, 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 (SUBJECT DEVICE). THEREAFTER AN OVERLAPPING 2ND STENT 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 7827945 ↗
Other intracranial neurovascular stent devices
- CERENOVUS ENTERPRISE ENF402312Medos International Sàrl · intracranial neurovascular stent1 death90 reports
- PulseRider Aneurysm Neck Reconstruction Device 201-DMedos International Sàrl · Intracranial Neurovascular Stent2 deaths74 reports
- CERENOVUS ENTERPRISE ENF402300Medos International Sàrl · intracranial neurovascular stent2 deaths66 reports
- CERENOVUS ENTERPRISE ENF403012Medos International Sàrl · intracranial neurovascular stent1 death42 reports
- CERENOVUS ENTERPRISE ENF452212Medos International Sàrl · intracranial neurovascular stent41 reports
- CERENOVUS ENTERPRISE ENF401600Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF401612Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF452812Medos International Sàrl · intracranial neurovascular stent31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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