TREVO NXT 3MM X 32MM - US
Received Oct 7, 2020 · Event occurred Sep 12, 2020
Report 3012931345-2020-00154 · MDR key 10645249
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityModel number
90312Catalog number
90312
Lot number
43835
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BLEEDING WAS REPORTED DURING THE PROCEDURE AT A TARGET LOCATION WHERE A RETRIEVER (SUBJECT DEVICE) WAS PLACED INSIDE THE PATIENT'S ANATOMY AND N-BUTYL CYANOACRYLATE (NBCA) WAS INJECTED TO STOP BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Additional Manufacturer Narrative
H4 MANUFACTURING DATE ¿ ADDED D4 EXPIRATION DATE - ADDED BASED ON THE RESULTS OF THE DHR REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, VISUAL AND FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. THE REPORTED EVENT COULD NOT BE CONFIRMED AND IT CANNOT BE CONFIRMED IF THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. 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. AS PER THE ADDITIONAL INFORMATION THE DOCTORS BELIEVED THAT THE DIRECT CAUSE WAS UNKNOWN. THE DEVICE PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING: AND THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT. 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, AN ASSIGNABLE CAUSE OF PATIENT-ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THIS COMPLAINT.
Additional Manufacturer Narrative
DEVICE IS NOT AVAILABLE TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT BLEEDING WAS REPORTED DURING THE PROCEDURE AT A TARGET LOCATION WHERE A RETRIEVER (SUBJECT DEVICE) WAS PLACED INSIDE THE PATIENT'S ANATOMY AND N-BUTYL CYANOACRYLATE (NBCA) WAS INJECTED TO STOP BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.