TREVO NXT 3MM X 32MM - US
Received Aug 25, 2023 · Event occurred Jul 31, 2023
Report 3012931345-2023-00198 · MDR key 17627033
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityCatalog number
90312
Lot number
0000211916
Product problems
- Fracture
- Fracture
Patient
67 YR · Male
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
MANUFACTURING DATE ¿ ADDED EXPIRATION DATE - ADDED THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. VISUAL AND FUNCTIONAL INSPECTIONS WERE NOT CONDUCTED DUE TO 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. THE REPORTED EVENT COULD NOT BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT THE RETRIEVER BROKE OFF AND WAS LEFT IN THE PATIENT. AS PER THE ADDITIONAL INFORMATION, THE PATIENT¿S ANATOMY WAS VERY TORTUOUS AND THERE WAS DIFFICULTY ADVANCING THE RETRIEVER UP THE MICROCATHETER. THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED EVENT, HOWEVER, AS THE DEVICE WAS NOT RETURNED AND A REVIEW OF ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THE REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING M2 THROMBECTOMY, THE OPERATOR ATTEMPTED TO DEPLOY THE SUBJECT RETRIEVER BUT MET RESISTANCE. THE OPERATOR REMOVED THE RETRIEVER AND THE MICROCATHETER. NO ISSUES WAS SEEN ON THE IMAGING. A PORTION OF THE SUBJECT RETRIEVER WAS SEEN ON THE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN DONE THE NEXT DAY. THE SUBJECT RETRIEVER BROKE OFF AND WAS LEFT INSIDE PATIENT'S ANATOMY. THE IMPACT TO THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT DURING M2 THROMBECTOMY, THE OPERATOR ATTEMPTED TO DEPLOY THE SUBJECT RETRIEVER BUT MET RESISTANCE. THE OPERATOR REMOVED THE RETRIEVER AND THE MICROCATHETER. NO ISSUES WAS SEEN ON THE IMAGING. A PORTION OF THE SUBJECT RETRIEVER WAS SEEN ON THE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN DONE THE NEXT DAY. THE SUBJECT RETRIEVER BROKE OFF AND WAS LEFT INSIDE PATIENT'S ANATOMY. THE IMPACT TO THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.