inforMED
InjuryPOL

TREVO NXT 3MM X 32MM - CE

Received Mar 13, 2023 · Event occurred May 21, 2022

Report 3012931345-2023-00044 · MDR key 16534793

Device

Generic name

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Catalog number

90412

Lot number

0000106543

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

74 YR · Female

  • Hemorrhage/Blood Loss/Bleeding
  • Perforation of Vessels
  • Embolism/Embolus
  • Hemorrhage/Blood Loss/Bleeding
  • Perforation of Vessels
  • Embolism/Embolus

Narrative

Additional Manufacturer Narrative

D4: EXPIRATION DATE: ADDED. H4: MANUFACTURING DATE: ADDED. F10/H6: CLINICAL SIGNS CODE GRID: CORRECTED. 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 3RD PASS OF THROMBECTOMY PROCEDURE, THE CONTROL SHOWS A RUPTURE OF THE LEFT PCA (POSTERIOR CEREBRAL ARTERY) AND A MIGRATION OF THE EMBOLUS IN THE RIGHT PCA. POST-PROCEDURE CT (COMPUTED TOMOGRAPHY) SCAN SHOWED EXTRAVASATION OF CONTRAST MEDIUM IN P1P2., INDICATING SUBARACHNOID BLEEDING PER PROCEDURE, WITHOUT SIGNIFICANT INTRAVENTRICULAR HEMORRHAGE OR HYDROCEPHALUS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER MANAGEMENT. NO OTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE SUBJECT DEVICE IS UNAVAILABLE TO MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT AFTER 3RD PASS OF THROMBECTOMY PROCEDURE, THE CONTROL SHOWS A RUPTURE OF THE LEFT PCA (POSTERIOR CEREBRAL ARTERY) AND A MIGRATION OF THE EMBOLUS IN THE RIGHT PCA. POST-PROCEDURE CT (COMPUTED TOMOGRAPHY) SCAN SHOWED EXTRAVASATION OF CONTRAST MEDIUM IN P1P2., INDICATING SUBARACHNOID BLEEDING PER PROCEDURE, WITHOUT SIGNIFICANT INTRAVENTRICULAR HEMORRHAGE OR HYDROCEPHALUS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER MANAGEMENT. NO OTHER INFORMATION WAS PROVIDED.