BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10700588 · Received October 19, 2020

    Report

    Report Number
    2024168-2020-08708
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 19, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227448
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF PERFORATION IS LISTED IN THE XIENCE SIERRA, EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), ELECTRONIC INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. THE OTHER DEVICES MENTIONED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY STENTING PROCEDURE, A 3.0 X 15 MM XIENCE SIERRA DRUG-ELUTING STENT WAS DEPLOYED ACROSS THE DISTAL STENOSIS AT 16 ATMOSPHERES. AT THAT TIME, THERE WAS A DISRUPTION OF THE PROXIMAL TO MID RIGHT CORONARY ARTERY STENOSIS AND THE DECISION WAS MADE TO COVER THIS AREA WITH A DRUG-ELUTING STENT. A 3.5 X 28 MM XIENCE SIERRA WAS THEN SUCCESSFULLY IMPLANTED AND POST-DILATED WITH A 3.5X20MM NC TREK. AFTER POST-DILATATION, A PERFORATION WAS NOTED. AT THAT TIME, A 3.5 X16 MM GRAFTMASTER COVERED STENT (9072241) WAS IMPLANTED ACROSS THE PERFORATION AT 20 ATMOSPHERES (ABOVE RATED BURSE PRESSURE), RESOLVING THE PERFORATION; HOWEVER, THE STENT WAS POST-DILATED WITH THE 3.5X20MM NC TREK AND THE PERFORATION WAS NOTED TO CONTINUE TO LEAK. TWO ADDITIONAL 3.5X19 GRAFTMASTER STENTS (9112841, 9032941) WERE IMPLANTED, ONE PROXIMAL AND ONE DISTAL TO THE IMPLANTED 3.5X16MM GRAFTMASTER STENT, BUT THE PERFORATION CONTINUED TO LEAK. AN ADDITIONAL XIENCE SIERRA 3.5 X 38 MM STENT WAS IMPLANTED BUT THE PERFORATION CONTINUED TO LEAK. A 2.8X19MM GRAFTMASTER STENT (8120641) WAS ADVANCED, BUT FAILED TO GET DISTAL TO THE LAST GRAFTMASTER STENT AND THE XIENCE SIERRA. ANOTHER 2.8X19MM GRAFTMASTER STENT (9092641) KINKED UPON INSERTION INTO THE PATIENT. A 3.5X19 GRAFTMASTER STENT (9060541) WAS ADVANCED, BUT FAILED TO CROSS THE IMPLANTED XIENCE SIERRA STENT. ANOTHER 2.8X19MM GRAFTMASTER STENT (8120641) WAS ADVANCED BUT FAILED TO GET DISTAL TO THE LAST GRAFTMASTER STENT AND THE XIENCE SIERRA. THE PATIENT WAS TAKEN TO SURGERY WHERE THE PERFORATION WAS TREATED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162355 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550350-28 0033141 08717648227448

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention