inforMED
InjuryPOL

TREVO NXT 6MM X 37MM - US

Received Mar 2, 2022 · Event occurred Jan 23, 2022

Report 3012931345-2022-00040 · MDR key 13654543

Device

Generic name

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Model number

90315

Catalog number

90315

Lot number

58683

Product problems

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

Patient

Female

  • Intracranial Hemorrhage
  • Intracranial Hemorrhage

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A THROMBUS RETRIEVAL FOR AN ACUTE IC OCCLUSION TREATMENT, A GUIDE CATHETER AND A MICROCATHETER WERE USED TO DELIVER THE SUBJECT RETRIEVER TO THE TARGET SITE. THROMBUS WAS SUCCESSFULLY REMOVED; HOWEVER, OVER CONTRAST RUN IMMEDIATELY AFTER THE RETRIEVAL MASSIVE BLEEDING WAS OBSERVED IN THE IC. A MILD ATHEROSCLEROTIC LESION WAS CONSIDERED BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT¿S ANATOMY WAS NORMAL AND THERE WAS NO HEALTH DAMAGES AT THE PRESENT, BUT, THE PATIENT'S PROGNOSIS IS LIKELY TO BE POOR. NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. NO VISUAL OR FUNCTIONAL INSPECTION WAS PERFORMED DUE TO PRODUCT 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. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT AND WAS PREPARED AS PER THE DFU. THE SUBJECT STENT WAS INSERTED INTO THE MICROCATHETER AND DEPLOYED AT THE LESION SITE. AFTER WAITING FOR A FEW MINUTES, THE STENT WAS COMBINED WITH DISTAL ACCESS CATHETER AND COLLECTED AS A SINGLE MASS. RETRIEVED THROMBUS WAS SEEN IN THE STENT. THE IMMEDIATE CONTRAST SHOWED MASSIVE BLEEDING FROM THE IC. ALTHOUGH A MILD ATHEROSCLEROTIC LESION WAS CONSIDERED, THE PASSAGE OF THE LESION WAS SMOOTH FROM CATHETER GUIDANCE TO STENT DEPLOYMENT, AND THE TECHNIQUE WAS CONSIDERED TO BE FLAWLESS. HEMOSTASIS WAS ACHIEVED BY INFLATING THE OCCLUSION BALLOON PROXIMAL TO THE LESION, THEREBY INTERRUPTING BLOOD FLOW, AND WAITING BY FOR HEMOSTASIS. THE REPORTED 'PATIENT INTRACRANIAL HEMORRHAGE' IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE. THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING A THROMBUS RETRIEVAL FOR AN ACUTE IC OCCLUSION TREATMENT, A GUIDE CATHETER AND A MICROCATHETER WERE USED TO DELIVER THE SUBJECT RETRIEVER TO THE TARGET SITE. THROMBUS WAS SUCCESSFULLY REMOVED; HOWEVER, OVER CONTRAST RUN IMMEDIATELY AFTER THE RETRIEVAL MASSIVE BLEEDING WAS OBSERVED IN THE IC. A MILD ATHEROSCLEROTIC LESION WAS CONSIDERED BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT¿S ANATOMY WAS NORMAL AND THERE WAS NO HEALTH DAMAGES AT THE PRESENT, BUT, THE PATIENT'S PROGNOSIS IS LIKELY TO BE POOR. NO ADDITIONAL INFORMATION AVAILABLE.