BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8318189 · Received February 7, 2019

    Report

    Report Number
    2024168-2019-00957
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    November 6, 2018
    Report Date
    April 19, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: CATALOG NUMBER UPDATED FROM 1500275-28 TO 1500250-18. LOT NUMBER UPDATED FROM 8073041 TO 8091741. EVALUATION SUMMARY: A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED INFLATION ISSUE WAS CONFIRMED. 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. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED INFLATION ISSUE. IN THIS CASE, IT IS POSSIBLE THAT PROCEDURAL CONTAMINANTS (BLOOD/CONTRAST) CONTRIBUTED TO THE REPORTED INFLATION ISSUE; HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED ISSUES CANNOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED AND ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, CUSTOMER CONFIRMED INFLATION DID NOT WORK INSIDE THE ANATOMY BUT WORKED DURING PREPARATION OUTSIDE THE PATIENT. THE STANDARD RATED BURST PRESSURE WAS USED AND THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RETURNED. ANALYSIS 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 LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. THE XIENCE SIERRA 2.75 X 18 MM STENT BALLOON FAILED TO INFLATE. A NEW INFLATION DEVICE WAS USED BUT STILL WOULD NOT INFLATE THE BALLOON. ALTHOUGH THE DEVICE WAS ATTEMPTED TO PRESSURIZE TO RATED BURST PRESSURE, IT DID NOT WORK. THE DEVICE WAS REMOVED FROM THE ANATOMY AND WAS ABLE TO INFLATE. IT WAS STATED THAT THE BALLOON WAS NOT RUPTURED. THE CASE WAS SUCCESSFULLY FINISHED WITH OTHER STENTS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109782 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8091741

    Patients

    Seq Age Sex Outcome Treatment
    1