TREVO NXT 3MM X 32MM - CE
Received Mar 10, 2023 · Event occurred Feb 14, 2023
Report 3012931345-2023-00043 · MDR key 16523063
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityCatalog number
90412
Lot number
0000184426
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
D4: EXPIRATION DATE: ADDED. H4: MANUFACTURING DATE: ADDED. 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 PHYSICAL ANALYSIS CANNOT BE PERFORMED. THE DEVICE WAS NOT RETURNED, THEREFORE IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION. 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. BASED UPON MEDICAL REVIEW, GOOD FAITH EFFORTS HAVE BEEN EXHAUSTED IN RESPONSE TO A REQUEST FOR FURTHER INFORMATION AND THE LIMITED INFORMATION AVAILABLE DOES NOT INDICATE A NEED FOR ESCALATION OF THE EVENT TO THE SENIOR MANAGEMENTS. AS THE AS REPORTED EVENTS ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE, A PROBABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.
Description of Event or Problem
IT WAS REPORTED THAT AFTER PROCEDURE, THE PATIENT WAS DIAGNOSED WITH DEFINITIVE HEMORRHAGIC REMODELING PRECENTRAL LEFT HI2. THE MEDICATION WAS ADMINISTERED TO PATIENT IN RESPONSE TO THE HEMORRHAGIC REMODELING. THE PATIENT IS NOT YET RECOVERED. NO OTHER INFORMATION WAS PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT AFTER PROCEDURE, THE PATIENT WAS DIAGNOSED WITH DEFINITIVE HEMORRHAGIC REMODELING PRECENTRAL LEFT HI2. THE MEDICATION WAS ADMINISTERED TO PATIENT IN RESPONSE TO THE HEMORRHAGIC REMODELING. THE PATIENT IS NOT YET RECOVERED. NO OTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THE SUBJECT DEVICE REMAINED INSIDE PATIENT.