BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 14785552 · Received June 23, 2022

    Report

    Report Number
    3002808486-2022-00855
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    November 24, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK ZDEG. SIMILAR TO DEVICE UNDER PMA/510(K) P180001. (B)(4). INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). H6) E2402 - APPROPRIATE TERM / CODE NOT AVAILABLE FOR CEREBELLAR INFARCTION. SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT ADRESSES CEREBRAL INFARCTION. FROM A PUBLICATION REVIEW, COOK MEDICAL BECAME AWARE OF A LITERATURE ARTICLE 27MAY2022. THE ARTICLE DESCRIBES A 49-YEAR-OLD MALE PATIENT UNDERWENT EMERGENCY TEVAR 5 YEARS AGO DUE TO EXTENSIVE ISCHEMIA BELOW THE ABDOMEN CAUSED BY ACUTE TYPE B DISSECTION. THE PROXIMAL DEVICE WAS PLACED IN ZONE 2 WITH AN AXILLARY-AXILLARY ARTERY BYPASS (AX-AX). THE DEVICE WAS A TXD, 34MM IN THE PROXIMAL AND TAPERED 24M IN THE DISTAL SITE AND 36MM BARE STENT WAS ADDED TO THE DISTAL DEVICE. THE LEFT SUBCLAVIAN ARTERY (LSCA) ORIGIN WAS NOT EMBOLIZED. POSTOPERATIVELY, ISCHEMIA WAS RESOLVED AND REMODELING WAS SUCCESSFUL. THIS TIME, CEREBELLAR INFARCTION OCCURRED ON THE PATIENT. THE CAUSE WAS FOUND TO BE THAT THE ORIGIN OF THE LSCA WAS PARTIALLY PATENT BY MIGRATION OF THE PROXIMAL DEVICE, AND A THROMBUS AT THE ROOT TRAVELED TO THE LEFT VERTEBRAL ARTERY AREA. FOLLOW-UP CT SHOWED GRADUAL MIGRATION OF THE DEVICE. AFTER SYMPTOMS OF THE CEREBELLAR INFARCTION GOT CALMED, ADDITIONAL TEVAR WAS PERFORMED IN THE PROXIMAL SITE. DISCUSSION/CONCLUSION: ¿ALTHOUGH REMODELING OF THE AORTA SEEMS TO BE SUCCESSFUL IN TEVAR FOR ACUTE TYPE B DISSECTION, MIGRATION TO THE DISTAL SIDE MAY OCCUR DURING THE PERIOD AFTER THE INITIAL TREATMENT AS THE PROXIMAL SIDE MAY NOT BE OVERSIZED. THIS IS ESPECIALLY IMPORTANT IN THE CASE OF A 10MM TAPER DISSECTION. THIS MIGRATION IS HARD TO BE RECOGNIZED, SO WE SHOULD ALWAYS KEEP IT IN MIND DURING FOLLOW-UP CT. IN SOME CASES, IT MAY CAUSE CEREBRAL INFARCTION IN THE LEFT VERTEBRAL ARTERY REGION. PER THE REPORTED INFORMATION, THE CAUSE OF CEREBRAL INFARCTION WAS FOUND TO BE THAT THE ORIGIN OF THE LSCA WAS PARTIALLY PATENT BY MIGRATION OF THE PROXIMAL DEVICE, AND A THROMBUS AT THE ROOT TRAVELED TO THE LEFT VERTEBRAL ARTERY AREA¿. THE MEANING OF THE ¿ROOT¿ WAS NOT ELABORATED. PER THE REPORTED INFORMATION FROM THE REP, BUT NOT CONFIRMED BY THE PHYSICIAN ¿FOR DISSECTION CASES, PHYSICIANS TEND NOT TO MAKE USUAL DEVICE SELECTION* (*USUAL DEVICE SELECTION: 4 MM UP AGAINST THE NATIVE VESSEL) BY CONSIDERING THE FRAGILITY OF THE VESSEL IN THE PROXIMAL NECK BUT THEY SELECT A DEVICE OF THE SAME DIAMETER AS THE VESSEL OR ONLY ONE SIZE UP (OVERSIZE). THEREFORE, THIS STATEMENT IS LIKELY TO BE SAYING THAT THE NON-OVERSIZED DEVICE SELECTION COULD CAUSE MIGRATION EASILY.¿ NO IMAGING WAS PROVIDED FOR INVESTIGATION. PER THE SIZING GUIDE FOR PROXIMAL TAPERED DEVICES ¿ 10 MM, AORTIC VESSEL WITH PROXIMAL DIAMETER MEASURED TO 30 MM AND DISTAL DIAMETER MEASURED TO 21 MM REQUIRES THE DEVICE WITH GRAFT DIAMETER ON 34 MM PROXIMALLY AND 24MM DISTALLY. ACCORDING TO THE IFU, SIZING OUTSIDE OF THE RECOMMENDATIONS CAN RESULT IN DEVICE MIGRATION. THE INFORMATION REGARDING VESSEL SIZE WAS NOT PROVIDED. IF SIZING WAS ACCORDING TO THE INFORMATION PROVIDED BY REP.(A DEVICE OF THE SAME DIAMETER AS THE VESSEL OR ONLY ONE SIZE UP), THE VESSEL DIAMETER WOULD BE 34 OR 33 MM. THE CHOICE OF THE DEVICE WITH PROXIMAL DIAMETER ON 34 MM IS OUTSIDE OF RECOMMENDATIONS IN THE SIZING GUIDE FOR PROXIMAL TAPERED DEVICES FOR THESE VESSEL DIAMETERS. BASED ON THE PROVIDED INFORMATION, THE CAUSE OF CEREBRAL INFARCTION IS LIKELY RELATED TO THE STENT GRAFT MIGRATION WHICH RESULTED IN THE LEFT SUBCLAVIAN ARTERY BECAME PATENT AND A THROMBUS TRAVELED TO THE LEFT VERTEBRAL ARTERY. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 49-YEAR-OLD MALE PATIENT UNDERWENT EMERGENCY TEVAR 5 YEARS AGO DUE TO EXTENSIVE ISCHEMIA BELOW THE ABDOMEN CAUSED BY ACUTE TYPE B DISSECTION. THE PROXIMAL DEVICE WAS PLACED IN ZONE 2 WITH AN AXILLARY-AXILLARY ARTERY BYPASS (AX-AX). THE DEVICE WAS A TXD, 34MM IN THE PROXIMAL AND TAPERED 24M IN THE DISTAL SITE AND 36MM BARE STENT WAS ADDED TO THE DISTAL DEVICE. THE LEFT SUBCLAVIAN ARTERY (LSCA) ORIGIN WAS NOT EMBOLIZED. POSTOPERATIVELY, ISCHEMIA WAS RESOLVED AND REMODELING WAS SUCCESSFUL. THIS TIME, CEREBELLAR INFARCTION OCCURRED ON THE PATIENT. THE CAUSE WAS FOUND TO BE THAT THE ORIGIN OF THE LSCA WAS PARTIALLY PATENT BY MIGRATION OF THE PROXIMAL DEVICE, AND A THROMBUS AT THE ROOT TRAVELED TO THE LEFT VERTEBRAL ARTERY AREA. FOLLOW-UP CT SHOWED GRADUAL MIGRATION OF THE DEVICE. AFTER SYMPTOMS OF THE CEREBELLAR INFARCTION GOT CALMED, ADDITIONAL TEVAR WAS PERFORMED IN THE PROXIMAL SITE. PATIENT OUTCOME: THE PATIENT HAD A FAVORABLE OUTCOME AFTER THE OPERATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983169 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention