BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8642444 · Received May 24, 2019

    Report

    Report Number
    2024168-2019-04106
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    May 7, 2019
    Report Date
    July 31, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER CHANGED FROM 8110640 TO 8110641 CORRECTION: DEVICE EVALUATED BY MFR: DEVICE STATUS CHANGED FROM YES TO NO. DEVICE CODE 2017: FAILURE TO FOLLOW INSTRUCTIONS, CONTRAST INCORRECT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DEFLATION ISSUE AND DIFFICULTY TO REMOVE APPEARS TO BE RELATED TO THE USE ERROR. IT WAS REPORTED THAT RESISTANCE WAS FELT DURING RETRACTION OF THE DEVICE AND FORCE WAS APPLIED. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION, EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), INSTRUCTIONS FOR USE (IFU)STATES: APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED EVENT. IN ADDITION, IT WAS REPORTED THAT THE CONTRAST MIX USED FOR THE PROCEDURE WAS 1 IN 3. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION,(EECSS), IFU STATES: MIXTURE SHOULD BE 60% CONTRAST DILUTED 1:1 WITH NORMAL SALINE. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, IT WAS REPORTED THAT NEGATIVE PRESSURE WAS HELD FOR 3-5 SECONDS IN ORDER TO DEFLATE THE BALLOON OF THE 3.00 X 48 MM XIENCE XPEDITION STENT DELIVERY SYSTEM; HOWEVER, THE BALLOON COMPLETELY FAILED TO DEFLATE. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION,(EECSS), IFU STATES: DEFLATE THE BALLOON BY PULLING NEGATIVE ON THE INFLATION DEVICE FOR 30 SECONDS. CONFIRM COMPLETE BALLOON DEFLATION BEFORE ATTEMPTING TO MOVE THE DELIVERY SYSTEM. IN THIS CASE, IT IS LIKELY THE IFU DEVIATION CONTRIBUTED TO THE REPORTED DEFLATION ISSUE AND DIFFICULTY TO REMOVE. THERE WAS NO REPORT OF ANY DAMAGE NOTED TO THE STENT DELIVERY SYSTEM (SDS) DURING INSPECTION OR PREPARATION OF THE DEVICE, WHICH SUGGESTS THAT A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED COMPLAINT. THE REPORTED PATIENT EFFECT OF HEMORRHAGE IS LISTED IN THE XIENCE XPEDITION, EVEROLIMUS(EECSS), IFU AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. A CINE WAS RECEIVED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE REVIEWER CONCLUDED THAT FOLLOWING SUCCESSFUL DEPLOYMENT OF A 3.0 X 48 XIENCE XPEDITION, SDS BALLOON FAILED TO DEFLATE COMPLETELY AND WAS SUCCESSFULLY WITHDRAWN FROM THE DEPLOYED STENT, BUT WAS UNABLE TO BE PULLED BACK INTO THE GUIDE CATHETER. THE STENT APPEARS FULLY DEPLOYED IN FINAL ANGIOGRAM.

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: FIELDER FC, GUIDE CATHETER: MEDTRONIC LAUNCHER EBU 1.5, THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED DE NOVO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.0X48MM XIENCE XPEDITION STENT WAS IMPLANTED AT THE LESION BUT THE BALLOON WAS UNABLE TO BE DEFLATED. THE INDEFLATOR WAS CHANGED THREE TIMES IN ATTEMPTS TO DEFLATE THE BALLOON HOLDING NEGATIVE FOR 3-5 SECONDS BUT WAS UNSUCCESSFUL. THE PATIENT BEGAN EXPERIENCING ST-TRANSIENT ELEVATION. FINALLY THE DELIVERY SYSTEM WAS FORCIBLY PULLED OUT WITH THE INTRODUCER SHEATH AS A SINGLE UNIT AND THE PATIENT BEGAN TO BLEED OUT MORE THAN USUAL AT THE ACCESS SITE DUE TO LONGER PROCEDURE TIME. THE PROCEDURE WAS ABORTED AND THE PATIENT REMAINED HOSPITALIZED AND WAS DISCHARGED AFTER 2 DAYS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435988 XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8110641

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10 FOR CONCOMITANT MEDICAL DEVICES