UNKNOWN_NEUROVASCULAR_PRODUCT
Received Jun 5, 2025 · Event occurred Dec 30, 2023
Report 3012931345-2025-00100 · MDR key 22154429
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityCatalog number
UNK_NEU
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IN DISCOUNT (EVALUATION OF MECHANICAL THROMBECTOMY IN ACUTE ISCHEMIC STROKE RELATED TO A DISTAL ARTERIAL OCCLUSION) STUDY, THERE WAS HEMORRHAGIC TRANSFORMATION WITH WORSENING OF CLINICAL CONDITION IN A CONTEXT OF FAILED RECANALIZATION ON (B)(6) 2023. PATIENT DIED ON (B)(6) 2024. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF DEATH IS UNKNOWN AS THE PATIENT WAS LOST OF VIEW.
Additional Manufacturer Narrative
ALTHOUGH THE LOT# IS UNKNOWN THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, VISUAL TESTING AS WELL AS FUNCTIONAL TESTING CANNOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. THIS CASE WAS A CLINICAL STUDY "HEMORRHAGIC TRANSFORMATION WITH WORSENING OF CLINICAL CONDITION IN A CONTEXT OF FAILED RECANALIZATION." AS PER THE TREVO NXT IFU, PATIENT DEATH AND INTRACRANIAL HEMORRHAGE ARE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATIONS. AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THE REPORTED EVENTS OF 'PATIENT DEATH' AND 'PATIENT INTRACRANIAL HEMORRHAGE', AS A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITH THE DIRECTIONS FOR USE, PRODUCT LABELING AND/OR RISK DOCUMENTATION FILES.
Description of Event or Problem
IN DISCOUNT (EVALUATION OF MECHANICAL THROMBECTOMY IN ACUTE ISCHEMIC STROKE RELATED TO A DISTAL ARTERIAL OCCLUSION) STUDY, THERE WAS HEMORRHAGIC TRANSFORMATION WITH WORSENING OF CLINICAL CONDITION IN A CONTEXT OF FAILED RECANALIZATION ON (B)(6) 2023. PATIENT DIED ON (B)(6) 2024. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF DEATH IS UNKNOWN AS THE PATIENT WAS LOST OF VIEW.