TREVO NXT 4MM X 41MM - US
Received Sep 11, 2020 · Event occurred Aug 16, 2020
Report 3012931345-2020-00138 · MDR key 10525527
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
0000045954
Product problems
- Component Missing
- Component Missing
Patient
Not reported
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUBJECT DEVICE IS UNAVAILABLE TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS HARD TO SEE UNDER FLOURSCOPY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT AND THE PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
BASED ON THE RESULTS OF THE DHR (DEVICE HISTORY RECORD ) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT 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. AS PER THE ADDITIONAL INFORMATION, THIS IS MORE OF A COMPLAINT OF IT BEING HARDER TO VISUALIZE VS NOT BEING VISIBLE AT ALL. AS THE DEVICE WAS NOT RETURNED AND A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE OR PROBABLE ASSIGNABLE CAUSE FOR THE REPORTED EVENT, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THIS COMPLAINT.
Description of Event or Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS HARD TO SEE UNDER FLOURSCOPY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT AND THE PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.