TREVO NXT 6MM X 37MM - US

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER AS THE FRACTURED PORTIONED OF THE SUBJECT DEVICE WAS LEFT INSIDE THE PATIENT'S VASCULATURE.

Description of Event or Problem

IT WAS REPORTED THAT A COMBINATION MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR NIHSS 18 IN A PATIENT WITH INTRA CRANIAL ATHEROSCLEROTIC DISEASE IN THE RIGHT MIDDLE CEREBRAL ARTERY WITH CALCIFIED CLOT. DURING THE FIRST PASS MILD RESISTANCE WAS FELT IN THE PROXIMAL SUPRACLINOID WHILE ADVANCING THE SUBJECT RETRIEVER STENT AND WHEN ATTEMPTED TO RETRIEVE THE SUBJECT RETRIEVER STENT CORE WIRE BROKE. AN ATTEMPT WAS MADE TO RETRIEVE THE BROKEN SUBJECT RETRIEVER STENT USING A SNARE, BUT IT WAS NOT SUCCESSFUL AND THEREFORE THE SUBJECT RETRIEVER STENT WAS LEFT INSIDE THE PATIENT¿S VASCULAR ANATOMY (IN THE RIGHT MIDDLE CEREBRAL ARTERY). FOLLOW UP CT SCAN SHOWED SUBARACHNOID HEMORRHAGE WHICH WAS TREATED WITH MEDICAL MANAGEMENT. THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT WAS IN THE ICU (INTENSIVE CARE UNIT) ON A DAY WE RECEIVED THE INFORMATION. NO FURTHER INFORMATION IS AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT A COMBINATION MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR NIHSS 18 IN A PATIENT WITH INTRA CRANIAL ATHEROSCLEROTIC DISEASE IN THE RIGHT MIDDLE CEREBRAL ARTERY WITH CALCIFIED CLOT. DURING THE FIRST PASS MILD RESISTANCE WAS FELT IN THE PROXIMAL SUPRACLINOID WHILE ADVANCING THE SUBJECT RETRIEVER STENT AND WHEN ATTEMPTED TO RETRIEVE THE SUBJECT RETRIEVER STENT CORE WIRE BROKE. AN ATTEMPT WAS MADE TO RETRIEVE THE BROKEN SUBJECT RETRIEVER STENT USING A SNARE, BUT IT WAS NOT SUCCESSFUL AND THEREFORE THE SUBJECT RETRIEVER STENT WAS LEFT INSIDE THE PATIENT¿S VASCULAR ANATOMY (IN THE RIGHT MIDDLE CEREBRAL ARTERY). FOLLOW UP CT SCAN SHOWED SUBARACHNOID HEMORRHAGE WHICH WAS TREATED WITH MEDICAL MANAGEMENT. THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT WAS IN THE ICU (INTENSIVE CARE UNIT) ON A DAY WE RECEIVED THE INFORMATION. NO FURTHER INFORMATION IS AVAILABLE. IT WAS CONFIRMED ON 29-MAR-2022,THAT THE SAME REPORTED EVENT, PRODUCT HAD ALREADY BEEN ENTERED UNDER EMDR (INITIAL): CORE ID: (B)(4) AND REPORT ID: 3012931345-2022-00043. BASED ON THIS UPDATE, PI# (B)(4) FOR WHICH EMDR (INITIAL): CORE ID: (B)(4) AND REPORT ID: 3012931345-2022-00041 WAS FILED WILL BE CANCELLED DUE THIS DUPLICATE ENTRY. REFER TO PI# (B)(4)/ EMDR (INITIAL): CORE ID: (B)(4) AND REPORT ID: 3012931345-2022-00043 FOR THE CONTINUATION OF THE COMPLAINT PROCESS OF THE ALLEGED ISSUE ASSOCIATED WITH THE SUBJECT COMPLAINT DEVICE.

Additional Manufacturer Narrative

B5 EXECUTIVE SUMMARY - UPDATED (PI# (B)(4) FOR WHICH EMDR (INITIAL): CORE ID: (B)(4) AND REPORT ID: 3012931345-2022-00041 WAS FILED WILL BE CANCELLED DUE THIS DUPLICATE ENTRY).