BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 8582487 · Received May 6, 2019

    Report

    Report Number
    1820334-2019-01099
    Event Type
    Injury
    Date Received
    May 6, 2019
    Report Date
    July 10, 2019
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THE CAUSE FOR THIS EVENT CANNOT BE TRACED TO THE DEVICE, BUT TO AN ADVERSE EVENT RELATED TO THE PROCEDURE. REPORTEDLY, THE DEVICE WAS MANUALLY CURVED BY THE USER WHICH COULD HAVE RESULTED IN THE REPORTED FAILURE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE = DQX. OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = PRE-AMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE, FOLLOWING TRANSFEMORAL AORTIC VALVE IMPLANTATION (TAVI) INVOLVING AN 83 YEAR-OLD FEMALE PATIENT, A VENTRAL SEPTAL DEFECT (VSD) WAS OBSERVED ON A POST-PROCEDURE ECHOCARDIOGRAM. AN UNKNOWN COOK AMPLATZ EXTRA-STIFF WIRE GUIDE WAS USED TO DELIVER ANOTHER MANUFACTURER'S VALVE. POST-PROCEDURAL AORTIC REGURGITATION SEVERITY WAS REPORTEDLY MILD. ECHOCARDIOGRAPHY REVEALED MEMBRANOUS VSD. THE PATIENT HAD A HIGH GRADIENT BETWEEN THE LEFT AND RIGHT VENTRICLES, SUPPORTING THE DIAGNOSIS OF RESTRICTIVE-TYPE VSD. AORTIC VALVE CALCIFICATION WAS SAID TO BE SEVERE. AT THE ONE-YEAR FOLLOW-UP, THE PATIENT WAS REPORTEDLY HEMODYNAMICALLY STABLE. THE VSD WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT, AND NO FURTHER INTERVENTION WAS REQUIRED. THE AUTHORS MAKE SEVERAL HYPOTHESES REGARDING THE FORMATION OF THE VSD IN THIS CASE. THE FIRST IS DIRECT TRAUMA CAUSED BY THE BIOPROSTHETIC VALVE BY OVERESTIMATION OF THE SIZE LEADING TO HIGH PRESSURE BEING EXERTED ON THE LEFT VENTRICULAR OUTFLOW TRACT AND SEPTUM, LEADING TO TEARING OF THE SEPTUM. THE SECOND HYPOTHESIS IS THAT THE CONCENTRATED AMOUNT OF CALCIUM ON THE AORTIC VALVE AND LEFT VENTRICULAR OUTFLOW TRACT PERIMETER COULD LEAD TO VSD FORMATION. THIS IS THOUGHT TO BE THE RESULT OF PUSHING/PRESSING OF THE VALVE INTO THE SEPTUM. THE FINAL HYPOTHESIS FOR THE FORMATION OF THE VSD IS THE RESULT OF INDIRECT TRAUMA TO THE DISTAL OR APICAL INTERVENTRICULAR SEPTUM CAUSED BY THE STIFF WIRE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377173 DQX WIRE, GUIDE, CATHETER DQX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Disability EDWARD¿S SAPIEN XT 26| EDWARD¿S SAPIEN XT 26