BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SIERRA

    MDR report key: 8802700 · Received July 18, 2019

    Report

    Report Number
    2024168-2019-10133
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    November 16, 2018
    Report Date
    September 12, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD.NA

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED INFLATION ISSUE WAS CONFIRMED THROUGH OBSERVATION AND THE REPORTED LOOSE CONNECTION COULD NOT BE 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 DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THE DEVICE EXPERIENCED INFLATION ISSUES DUE TO THE NOTED CRACK IN THE HUB. THE REPORTED LOOSE CONNECTION WAS NOT CONFIRMED; HOWEVER, IT IS LIKELY THE LEAK DUE TO THE CRACK WAS IDENTIFIED AS A LOOSE CONNECTION. THE CAUSE OF THE CRACKED HUB CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. EXEMPTION NUMBER E2019001.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. A 3.50X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND DURING INFLATION THE BALLOON WOULD NOT INFLATE AS CONTRAST LEAKED FROM THE INFLATION PORT OF THE HUB THAT WAS CONNECTED TO THE INDEFLATOR. THE STENT WAS NOT IMPLANTED. A NEW UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. A 3.50X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND DURING INFLATION, THE BALLOON WOULD NOT INFLATE AS CONTRAST LEAKED FROM THE INFLATION PORT OF THE HUB THAT WAS CONNECTED TO THE INDEFLATOR. THE STENT WAS NOT IMPLANTED. A NEW UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 8/5/2019 ADDITIONAL INFORMATION RECEIVED: THE INFLATION DEVICE USED DURING THE PROCEDURE WAS A NON-ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596913 XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 8082041

    Patients

    Seq Age Sex Outcome Treatment
    1