TREVO NXT 3MM X 32MM - US
Received Jul 1, 2025 · Event occurred May 13, 2025
Report 3012931345-2025-00112 · MDR key 22375668
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityCatalog number
90312
Lot number
0000782715
Product problems
- Fracture
- Fracture
Patient
59 YR · Female
- Muscle Weakness/Atrophy
- Obstruction/Occlusion
- Foreign Body In Patient
- Muscle Weakness/Atrophy
- Obstruction/Occlusion
- Foreign Body In Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THROMBECTOMY PROCEDURE SUBJECT STENT RETRIEVER WIRE WAS UNABLE TO REMOVE SO IT WAS CUT AT SKIN IN RIGHT GROIN WITH DISTAL TIP REMAINING IN PATIENT'S VESSEL. POST-PROCEDURE OCCLUSION WAS OBSERVED WHICH LED TO PATIENT HAVING RHABDOMYOLYSIS AND WEAKNESS. NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
H4 MANUFACTURING DATE ¿ ADDED D4 EXPIRATION DATE - ADDED D4 GTIN - ADDED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT STENT RETRIEVER WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION 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 WAS UNABLE TO BE CONFIRMED, AND IT WAS UNABLE TO BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED EVENTS. IT IS PROBABLE THAT THERE WERE ANATOMICAL AND OR PROCEDURAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. A PROBABLE ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENT, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.
Description of Event or Problem
IT WAS REPORTED THAT DURING THROMBECTOMY PROCEDURE SUBJECT STENT RETRIEVER WIRE WAS UNABLE TO REMOVE SO IT WAS CUT AT SKIN IN RIGHT GROIN WITH DISTAL TIP REMAINING IN PATIENT'S VESSEL. POST-PROCEDURE OCCLUSION WAS OBSERVED WHICH LED TO PATIENT HAVING RHABDOMYOLYSIS AND WEAKNESS. NO FURTHER INFORMATION IS AVAILABLE.