BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 9983066 · Received April 21, 2020

    Report

    Report Number
    2024168-2020-03789
    Event Type
    Injury
    Date Received
    April 21, 2020
    Date of Event
    November 12, 2019
    Report Date
    April 21, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227110
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 OTHER SIMILAR INCIDENTS FROM THIS LOT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT(S) OF DISSECTION, STENOSIS, ANGINA, PROLAPSE AND OCCLUSION ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT-DEVICE INCOMPATIBILITY WALL APPOSITION CANNOT BE DETERMINED. THE REPORTED DIFFICULTIES POSSIBLY CONTRIBUTED TO THE REPORTED PATIENT EFFECTS HOWEVER A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE TREATMENT(S) APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    PATIENT ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS FROM A PREVIOUS PERCUTANEOUS CORONARY INTERVENTION, LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A SIDE BRANCH OF THE LAD WAS OCCLUDED. PRE-DILATATION WAS PERFORMED AND A 2.5X23MM XIENCE SIERRA STENT (1550250-23, 9072241) WAS SUCCESSFULLY IMPLANTED FROM THE PROXIMAL-MID LAD INTO THE 1ST ANTEROLATERAL BRANCH. THE STENT WAS FULLY APPOSED TO THE VESSEL WALL EXCEPT MALPOSITION INVOLVING THE CONTINUATION OF THE MID LAD DISTAL TO THE TAKEOFF OF THE 1ST ANTEROLATERAL. THE SIDE BRANCH HAD BECOME JAILED AFTER 2.5X23MM XIENCE SIERRA STENT IMPLANTATION. POST-IMPLANTATION, INTRA-STENT MINIMAL PLAQUE PROTRUSION AND A MINOR, PROXIMAL LAD DISSECTION WERE OBSERVED, BOTH OF WHICH DID NOT REQUIRE TREATMENT. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ANGINA. ON (B)(6) 2020, ANOTHER PCI WAS PERFORMED AND IN-STENT RESTENOSIS (99%) WAS OBSERVED IN THE MID LAD. ANOTHER STENT WAS IMPLANTED AS TREATMENT AND THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444882 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550250-23 9072241 08717648227110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R