TREVO NXT 4MM X 41MM - US
Received Jan 31, 2023 · Event occurred Jan 4, 2023
Report 3012931345-2023-00013 · MDR key 16269963
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
58207
Product problems
- Peeled/Delaminated
- Peeled/Delaminated
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS IS 4 OF 4 REPORTS. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE WHEN THE SUBJECT RETRIEVER STENT WAS STORED IN A TRAY , SOMETHING LIKE COATING SUBSTANCE WAS FOUND FLOATING IN THE SALINE SOLUTION IN THE TRAY. IT IS UNCLEAR AT WHAT POINT IN TIME THIS OCCURRED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Description of Event or Problem
IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE WHEN THE SUBJECT RETRIEVER STENT WAS STORED IN A TRAY , SOMETHING LIKE COATING SUBSTANCE WAS FOUND FLOATING IN THE SALINE SOLUTION IN THE TRAY. IT IS UNCLEAR AT WHAT POINT IN TIME THIS OCCURRED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Additional Manufacturer Narrative
B1: ADVERSE EVENT/PRODUCT PROBLEM ¿ CORRECTED - NO ¿PRODUCT PROBLEM¿. H1: TYPE OF REPORTABLE EVENT ¿ CORRECTED - NO ¿MALFUNCTION¿. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS VISUAL 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 EVENT COULD NOT BE CONFIRMED AND IT CANNOT BE DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT WHEN THE DEVICES WERE REMOVED FROM THE PATIENT'S BODY AND STORED IN A TRAY AFTER COMPLETION OF THE TREATMENT, SOMETHING LIKE COATING SUBSTANCE WAS FOUND FLOATING IN THE SALINE SOLUTION IN THE TRAY. ANALYSIS CONFIRMED THAT THE COATING SUBSTANCE NOTED AFTER DEVICE REMOVAL, WAS IN FACT, PTFE COATING OF THE GUIDEWIRE INVESTIGATED UNDER THE SAME PARENT COMPLAINT. THERE IS NO PTFE COATING ASSOCIATED WITH RETRIEVER STENT. AN ASSIGNABLE CAUSE OF CAUSED BY OTHER WILL BE ASSIGNED TO THE REPORTED "HYDROPHILIC COATING PEELING', AS THE ISSUE WAS FOUND TO BE RELATED TO THE GUIDEWIRE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.