BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8224331 · Received January 7, 2019

    Report

    Report Number
    2024168-2019-00146
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    December 11, 2018
    Report Date
    January 28, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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 INTERACTED WITH THE HEAVY CALCIFIED AND 90% STENOSED LESION RESULTING IN THE REPORTED DIFFICULTY TO DEPLOY. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL XIENCE ALPINE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, FOLLOWING PRE-DILATATION, TWO 3.0X23MM XIENCE ALPINE STENTS (LOTS 8101941 AND 8070541) WERE IMPLANTED IN THE 3RD OBTUSE MARGINAL (OM) CORONARY ARTERY, SEVERELY CALCIFIED LESION. REGARDING THE SECOND IMPLANTED 3.0X23MM XIENCE ALPINE (LOT 8070541), PER ANGIOGRAPHY, THE POST STENT APPEARANCE WAS ACCEPTABLE, HOWEVER PER OCT IMAGING IT WAS NOT. A STENT'S PROXIMAL HALF WAS EXPANDED LESS THAN 90%. POST DILATATION WAS PERFORMED USING THE MAXIMUM SIZE BALLOON WITHOUT RESOLVE. A 3.0X18MM XIENCE ALPINE WAS ALSO IMPLANTED IN THE 3RD OM WHEN A PROXIMAL DISSECTION OCCURRED. THE PATIENT EXPERIENCED TRANSIENT ST ELEVATION AND OCT WAS UNABLE TO BE FURTHER PERFORMED DUE TO THE DISSECTION. ANOTHER STENT WAS IMPLANTED AS TREATMENT FOR THE ST ELEVATION AND DISSECTION. THE PROCEDURE THEN FOCUSED ON THE SECOND TARGET LESION. PRE-DILATATION WAS PERFORMED AT THE MID CIRCUMFLEX (CX) CORONARY ARTERY, HEAVILY CALCIFIED LESION AND A 3.5X23MM XIENCE ALPINE STENT WAS IMPLANTED. PER OCT RESULTS, THE PROXIMAL HALF AND DISTAL HALF OF THIS STENT WAS EXPANDED LESS THAN 90%. POST DILATATION WAS PERFORMED USING THE MAXIMUM SIZE BALLOON WITHOUT RESOLVE. NO OTHER TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15749 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8070541

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention