BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 8579258 · Received May 3, 2019

    Report

    Report Number
    1820334-2019-01027
    Event Type
    Injury
    Date Received
    May 3, 2019
    Report Date
    June 13, 2019
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, IT IS CONCLUDED THAT OUR DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT NOTED IN THE PROCEDURE. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 STATING "...NO COMPLICATIONS AS [OF] A COOK DEVICE HAS OCCURRED OR WERE REPORTED. WE DON´T USE AMPLATZ WIRE FROM COOK FOR COMMERCIAL REASONS..." IN LIGHT OF THIS INFORMATION, COOK WILL NOT BE SUBMIT A DEVICE INVESTIGATION REPORT AS IT HAS BEEN CONFIRMED THAT A COOK DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT THAT OCCURRED.

    Additional Manufacturer Narrative · 1

    PROCODE = DQX. PMA/510(K) NUMBER = PRE-AMENDMENT. (B)(4). CITATION: MENDIZ, O., FAVA, C., CERDA, M., LEV, G., CAPONI, G., & VALDIVIESO, L. (2017). "PERCUTANEOUS REPAIR OF LEFT VENTRICULAR PSEUDOANEURYSM AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT." CARDIOVASCULAR REVASCULARIZATION MEDICINE, 18 (6), 30-31. DOI: 10.1016/J.CARREV.2017.02.012. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION OR, WHEN ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    REVIEW OF A JOURNAL ARTICLE, "PERCUTANEOUS REPAIR OF LEFT VENTRICULAR PSEUDOANEURYSM AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT", REVEALED AN (B)(6) MALE WITH HISTORY OF SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND SEVERE AORTIC STENOSIS, THREE VESSEL CORONARY ARTERY BYPASS GRAFT (2011), ENDOVASCULAR ABDOMINAL AORTIC REPAIR (2012) AND LEFT VENTRICULAR EJECTION FRACTION OF SIXTY PER CENT, UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVR) VIA RIGHT SUBCLAVIAN ACCESS. AN AMPLATZ EXTRA STIFF WIRE (COOK, INC) WITH A SEVEN CENTIMETER SOFT TIP WAS USED. THE PROCEDURE WENT SMOOTHLY. THERE WERE NO IN-HOSPITAL COMPLICATIONS AND PRE-DISCHARGE TRANSTHORACIC ECHO WAS WITHIN NORMAL LIMITS. AT THIRTY DAY ROUTINE VISIT, LEFT VENTRICULAR PSEUDOANEURYSM (LVP) WAS FOUND BY TRANSTHORACIC ECHO AND MULTI-SLICE COMPUTED TOMOGRAPHY (MSCT). LVP CLOSURE WAS PERFORMED UNDER LIGHT SEDATION, THROUGH THE LEFT FEMORAL ARTERY ACCESS WITHOUT COMPLICATIONS. REPEAT VENTRICULOGRAPHY SHOWED ALMOST NO FLOW INTO THE PSEUDOANEURYSM. NEXT DAY TRANSTHORACIC ECHO SHOWED SIMILAR FINDINGS, WHILE SOME RESIDUAL FLOW WAS FOUND BY MSCT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AT THIRTY DAYS, THE PATIENT REMAINED ASYMPTOMATIC AND REPEAT ECHO AND MSCT SHOWED NO FLOW INTO THE PSEUDOANEURYSM CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372581 DQX WIRE, GUIDE, CATHETER DQX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R 29MM COREVALVE (MEDTRONIC)| 29MM COREVALVE (MEDTRONIC)