BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 12632349 · Received October 14, 2021

    Report

    Report Number
    2024168-2021-09223
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 3, 2021
    Report Date
    January 31, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IT WAS REPORTED THAT FOLLOWING STENT DEPLOYMENT AT NOMINAL PRESSURE, THE BALLOON WAS DIFFICULT TO REMOVE AFTER BEING DEFLATED AND USE OF FORCE WAS APPLIED. IT SHOULD BE NOTED THAT THE XIENCE PRIME / XIENCE PRIME SMALL VESSEL (SV), AND XIENCE PRIME LONG LENGTH (LL), EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), INSTRUCTIONS FOR USE (IFU) STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME WHEN WITHDRAWING THE STENT TOWARDS THE GUIDING CATHETER, THE STENT DELIVERY SYSTEM AND THE GUIDING CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND / OR 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 DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SIXTEEN STERILE DEVICES WERE RECEIVED AND TESTED FOR DEFLATION TIME IN THE RETURNED GOODS LAB AND EVALUATED FOR BALLOON SHAPE AFTER DEFLATION. ALL 16 DEVICES MET DEFLATION TIME SPECIFICATION. THERE ARE NO SPECIFICATIONS FOR BALLOON SHAPE, SPECIFICALLY ¿FLATNESS¿, POST DEFLATION; THEREFORE, BALLOON DEFLATING FLAT IS ACCEPTABLE FOR XIENCE PRIME. AN ADDITIONAL 11 UNITS WERE TESTED FOR DEFLATION TIME IN THE RETURNED GOODS LAB AND MET SPECIFICATION. THEREFORE, THERE IS NO INDICATION OF A PRODUCT ISSUE WITH THE STERILE DEVICES. THE TESTING OF THE RETURNED STERILE DEVICES INDICATED THERE WAS NO INDICATION OF A PRODUCT QUALITY ISSUE FOR THE STENT DELIVERY SYSTEM; HOWEVER, A LOT SPECIFIC (0061841) INDICATION CANNOT BE DETERMINED AS THE RETURNED STERILE DEVICES DID NOT CONTAIN THE SAME LOT NUMBER AS THE COMPLAINT DEVICE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO REMOVE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULT TO REMOVE COULD NOT BE TESTED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IT WAS REPORTED THAT FOLLOWING STENT DEPLOYMENT AT NOMINAL PRESSURE, THE BALLOON WAS DIFFICULT TO REMOVE AFTER BEING DEFLATED AND USE OF FORCE WAS APPLIED. IT SHOULD BE NOTED THAT THE XIENCE PRIME / XIENCE PRIME SMALL VESSEL (SV), AND XIENCE PRIME LONG LENGTH (LL), EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), INSTRUCTIONS FOR USE (IFU) STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME WHEN WITHDRAWING THE STENT TOWARDS THE GUIDING CATHETER, THE STENT DELIVERY SYSTEM AND THE GUIDING CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND / OR 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 DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO REMOVE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING D9 - DEVICE AVAILABLE FOR EVAL UPDATED FROM D9 - DEVICE AVAILABLE FOR EVAL UPDATED FROM NO TO YES. H3 - DEVICE RETURNED TO MANUFACTURER? UPDATED FROM NO TO YES. H6 -TYPE OF INVESTIGATION CODE 4117 (DEVICE NOT ACCESSIBLE FOR TESTING) WAS REMOVED AND CODE 10 (TESTING OF ACTUAL/SUSPECTED DEVICE) WAS ADDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. 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 MILDLY CALCIFIED DE NOVO LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 3.0X38MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS DEPLOYED AT NOMINAL PRESSURE. IT WAS NOTED AFTER POST DEPLOYMENT AND FULL DEFLATION OF THE SDS EXCESSIVE FORCE HAD TO BE USED AS THERE WAS DIFFICULTY IN REMOVING THE SDS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532523 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 0061841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown