BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2880145 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08170
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPROPER OR INCORRECT PROCEDURE OR METHOD, EXCESSIVE FORCE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION AND RESISTANCE/DIFFICULTY REMOVING THE DEVICE FROM THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE BASED ON OPERATIONAL CIRCUMSTANCES. STENT DISLODGEMENT AND BALLOON RUPTURE WERE CONFIRMED. BASED ON VISUAL, FUNCTIONAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT WAS REPORTED THAT FORCE WAS APPLIED DURING RETRIEVAL ATTEMPT. IT SHOULD BE NOTED THAT THE (B)(4) XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: RESISTANCE MAY INDICATE A PROBLEM AND THE USE OF EXCESSIVE FORCE MAY RESULT IN STENT DAMAGE OR DISLODGEMENT. SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, REMOVE THE ENTIRE SYSTEM AS A SINGLE UNIT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 90% STENOSED, PROXIMAL RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH A 2.5X15 MM NON-ABBOTT BALLOON, AFTER WHICH THE 3.5X15 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE SDS TO THE LESION, SO FORCE WAS APPLIED IN THE ATTEMPT TO CROSS. THE SDS BECAME CAUGHT IN THE VESSEL AND FORCE WAS USED IN THE ATTEMPT TO RETRACT THE CATHETER, WHICH RESULTED IN THE STENT IMPLANT DISLODGING SLIGHTLY PROXIMAL TO THE LESION. AN ATTEMPT WAS MADE TO CAPTURE THE DISLODGED STENT WITH THE SDS BALLOON; HOWEVER, THE ATTEMPT WAS ABORTED AS IT WAS THOUGHT THAT THE SDS BALLOON MAY HAVE RUPTURED. THE DISLODGED STENT WAS DEPLOYED PROXIMAL TO THE LESION WITH A NON-ABBOTT BALLOON CATHETER AND ANOTHER 3.5X18 MM XIENCE PRIME STENT WAS DEPLOYED DISTALLY, IN THE LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2083141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention