BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 8601811 · Received May 10, 2019

    Report

    Report Number
    1820334-2019-01199
    Event Type
    Injury
    Date Received
    May 10, 2019
    Report Date
    September 10, 2019
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DOCUMENTATION, AND QUALITY CONTROL PROCEDURES 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. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS 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 REPORTED EVENTS WERE LIKELY DUE TO THE PROCEDURE PERFORMED OR TO THE PATIENTS¿ CONDITIONS. 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 . CONCOMITANT MEDICAL PRODUCTS= EDWARDS SAPIEN XT VALVE AND NOVAFLEX DELIVERY SYSTEM, MEDTRONIC COREVALVE, ABBOTT 10F PROSTAR XL, UNKNOWN BALLOON DEVICES INITIAL REPORTER 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

    THE LITERATURE HAS REPORTED TRENDS IN OUTCOME AND SURVIVAL FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURES, DURING WHICH AN UNKNOWN COOK AMPLATZ EXTRA-STIFF WIRE WAS USED, AMONG OTHER PRODUCTS. BETWEEN 2010 AND 2013, 429 PATIENTS UNDERWENT TAVI IN THE STUDY CENTER. ALL PATIENTS INVOLVED IN THE STUDY HAD SEVERE SYMPTOMATIC AORTIC STENOSIS AND THE LOGISTIC EUROSCORE WAS GREATER THAN OR EQUAL TO 20% IN CASE OF FRAGILITY OR CO-MORBIDITY, CONTRAINDICATING SURGICAL AORTIC VALVE REPLACEMENT. THE MEAN PATIENT AGE WAS 84.1 YEARS. DURING THE PROCEDURES, AFTER CROSSING THE AORTIC VALVE, A PRE-SHAPED, 260 CM LONG, 0.035 INCH AMPLATZ EXTRA STIFF WIRE (COMPLAINT DEVICE) WAS PLACED INTO THE VENTRICLE. BALLOON SIZING WAS PERFORMED IN ALL CASES UNDER RAPID VENTRICULAR PACING, AS A FINAL ANNULUS ASSESSMENT TO CHOOSE THE VALVE SIZE. VALVE POSITIONING WAS BASED ON FLUOROSCOPY, USING ANNULAR CALCIFICATION AS A LANDMARK. ANOTHER MANUFACTURER¿S PROSTHESIS WAS THEN DELIVERED USING RAPID VENTRICULAR PACING. THE FEMORAL ARTERIOTOMY WAS CLOSED USING ANOTHER MANUFACTURER¿S DEVICE. IN THE ABSENCE OF A PERSISTENT ATRIOVENTRICULAR BLOCK, THE PACING LEAD WAS REMOVED AT THE END OF THE PROCEDURE. PATIENTS WERE MONITORED IN THE INTENSIVE CARE UNIT FOR AT LEAST 24 HOURS AFTER VALVE IMPLANTATION. THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE COMPLAINT DEVICE. PATIENT OUTCOMES REPORTED IN THE ARTICLE ARE AS FOLLOWS: TWO PATIENTS DIED FROM ANNULUS RUPTURE DESPITE A BAILOUT VALVE-IN-VALVE PROCEDURE; THIS IS REPORTED UNDER MDR 1820334-2019-01189. ONE PATIENT PRESENTED WITH A LEFT VENTRICULAR PERFORATION AND DIED AT DAY 1; THIS EVENT IS REPORTED UNDER MDR 1820334-2019-01190. THERE WERE NINETEEN OTHER UNSPECIFIED CASES OF 30-DAY PATIENT DEATHS; THIS IS REPORTED UNDER MDR 1820334-2019-01191. FIVE CASES OF ANNULUS RUPTURE NOT ASSOCIATED WITH DEATH ARE REPORTED UNDER MDR 1820334-2019-01192. EIGHT CASES OF CARDIAC TAMPONADE ARE REPORTED UNDER MDR 1820334-2019-01193. THREE CASES OF URGENT CARDIAC SURGERY ARE REPORTED UNDER MDR 1820334-2019-01194. FOURTEEN PATIENTS WERE REPORTED TO HAVE EXPERIENCED A STROKE; THIS IS REPORTED UNDER MDR 1820334-2019-01195. SIXTY-NINE CASES INVOLVED BLEEDING THAT REQUIRED A BLOOD TRANSFUSION; THIS IS REPORTED UNDER MDR 1820334-2019-01196. FIFTY-FOUR CASES OF ACUTE KIDNEY INJURY WERE REPORTED; THIS IS REPORTED UNDER MDR 1820334-2019-01197. THERE WERE EIGHTY-FIVE CASES OF VASCULAR COMPLICATIONS; THIS IS REPORTED UNDER MDR 1820334-2019-01198. THERE WERE SEVEN CASES OF PERIPROCEDURAL MYOCARDIAL INFARCTION; THIS IS REPORTED UNDER MDR 1820334-2019-01199. CITATION: AVINEE, G., DURAND, E., ELHATIMI, S., BAUER, F., GLINEL, B., DACHER, J.N., CELLIER, G., VIART, G., TRON, C., GODIN, M., LITZLER, P.Y., CRIBER, A., ELTCHANINOFF, H. (2016). TRENDS OVER THE PAST 4 YEARS IN POPULATION CHARACTERISTICS, 30-DAY OUTCOMES AND 1-YEAR SURVIVAL IN PATIENTS TREATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION. ARCHIVES OF CARDIOVASCULAR DISEASE, 109 (457-64). RETRIEVED FROM: HTTP://DX.DOI.ORG/10.1016/J.ACVD.2016.01.016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391575 DQX WIRE, GUIDE, CATHETER DQX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10