BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 8801660 · Received July 18, 2019

    Report

    Report Number
    3002808486-2019-01008
    Event Type
    Death
    Date Received
    July 18, 2019
    Date of Event
    May 22, 2019
    Report Date
    November 25, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002454088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON EVENT DESCRIPTION AND REVIEW OF PREOPERATIVE CT SCAN. IT WAS REPORTED THAT A TYPE A THORACIC AORTIC DISSECTION WAS DISCOVERED LESS THAN 1 WEEK AFTER TEVAR AND THAT THE WIRE GUIDE MAY HAVE TOUCHED THE PLACE, WHERE THE DISSECTION OCCURRED. POSTOPERATIVE IMAGING WAS NOT PROVIDED SO THE REPORTED DISSECTION CANNOT BE ASSESSED OR CONFIRMED. THE CAUSE OF THIS CANNOT BE DETERMINED FROM THE IMAGING PROVIDED. HOWEVER, ACCORDING TO THE REPORT, THE ENTRY TEAR FOR THE TYPE A DISSECTION WAS FOUND TO BE IN THE ASCENDING AORTA, AWAY FROM THE ZTA GRAFT. IN THIS CASE, THE DISSECTION IS UNLIKELY TO BE RELATED TO THE ENDOGRAFT DEVICE ITSELF. THIS IS EITHER A SPONTANEOUS EVENT OR CAUSED BY CATHETER/WIRE MANIPULATION IN THE ASCENDING AORTA AT THE TIME OF TEVAR. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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). 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.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: (B)(6) 2019 : POST-PROCEDURAL CONTRAST CT SCAN WAS PERFORMED. NO DISSECTIONS WERE CONFIRMED BUT TYPE I ENDOLEAK WAS CONFIRMED AT THAT TIME. (B)(6) 2019 : NON-CONTRAST HEAD CT SCAN WAS PERFORMED AND SUBARACHNOID HEMORRHAGE WAS CONFIRMED SO THE PATIENT WAS TRANSFERRED TO AGEO CENTRAL HOSPITAL. (B)(6) 2019 : NON-CONTRAST CT SCAN WAS PERFORMED AND THE TYPE A DISSECTION WAS CONFIRMED. THE ENTRY WAS NEARBY THE AORTIC VALVE IN THE ASCENDING AORTA. (B)(6) 2019 : THE PATIENT CONDITION CHANGED SUDDENLY. THE PATIENT DEVELOPED HEART TAMPONADE AND THE PATIENT DIED BEFORE BEING TREATED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SIMILAR TO DEVICE UNDER 510(K)/PMA: K171513. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2019 TEVAR WAS PERFORMED. MINIMUM DIAMETER OF THE PATIENT'S ACCESS ROUTE WAS 6.9 MM AND NO CALCIFICATIONS. THE PATIENT'S PROXIMAL NECK LENGTH WAS ONLY 12MM IF ZTA DEVICE WAS PLACED FROM ZONE3. DEBRANCHING OF LEFT SUBCLAVIAN ARTERY AND LEFT COMMON CAROTID ARTERY WERE TOO INVASIVE TO THE PATIENT CONSIDERING HER AGE, SO ONLY LEFT SUBCLAVIAN ARTERY WAS DEBRANCHED TO PLACE ZTA DEVICE. THE PATIENT ANATOMICAL CONDITION WAS NOT SUITABLE FOR USING ZTA DEVICE BUT ZTA-P-38-217-W1/ E3827315 AND ZTA-P-46-179-W1/ E3789936 WERE PLACED AND THE PROCEDURE WAS COMPLETED. DURING THE TEVAR, SOME CATHETERS (BOTH COOK DEVICES AND NON-COOK DEVICES) MAY HAVE TOUCHED THE PLACE WHERE THE ENTRY OF TYPE A DISSECTION OCCURRED LATER. ON (B)(6) 2019 THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. ON (B)(6) 2019 THE PATIENT CONDITION CHANGED SUDDENLY AND DIED ON THE DAY. NON CONTRAST MEDIA CT SCAN WAS PERFORMED AND TYPE A DISSECTION WAS CONFIRMED. THE ENTRY WAS NEARBY THE AORTIC VALVE IN THE ASCENDING AORTA. THE PATIENT DIED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595568 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45408 E3834898 00827002454088

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death