TREVO NXT 4MM X 41MM - US
Received Jan 31, 2021 · Event occurred Jan 4, 2021
Report 3012931345-2021-00024 · MDR key 11256610
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityModel number
90314Catalog number
90314
Lot number
0000053092
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
61 YR
- Extravasation
- Extravasation
Narrative
Additional Manufacturer Narrative
DEVICE IS NOT AVAILABLE TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT FOLLOW UP ANGIOGRAPHIC IMAGES TAKEN POST PROCEDURE, WHERE A RETRIEVER (SUBJECT DEVICE) WAS USED, SHOWED EXTRAVASATION IN PATIENT'S ANATOMY. THE PHYSICIAN EMBOLIZED THE EXTRAVASATION WITH LIQUID EMBOLIC AGENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Additional Manufacturer Narrative
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 DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE AND NO ISSUES GAINING ACCESS TO THE OCCLUSION. 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.
Description of Event or Problem
IT WAS REPORTED THAT FOLLOW UP ANGIOGRAPHIC IMAGES TAKEN POST PROCEDURE, WHERE A RETRIEVER (SUBJECT DEVICE) WAS USED, SHOWED EXTRAVASATION IN PATIENT'S ANATOMY. THE PHYSICIAN EMBOLIZED THE EXTRAVASATION WITH LIQUID EMBOLIC AGENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.