BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2823321 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07046
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF RESTENOSIS AND MYOCARDIAL INFARCTION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). IT SHOULD BE NOTED THE IFU STATES: IF THE DEPLOYED STENT SIZE IS STILL INADEQUATE WITH RESPECT TO REFERENCE VESSEL DIAMETER, A LARGER BALLOON MAY BE USED TO FURTHER EXPAND THE STENT. IF THE INITIAL ANGIOGRAPHIC APPEARANCE IS SUB-OPTIMAL, THE STENT MAY BE FURTHER EXPANDED USING A LOW PROFILE, HIGH PRESSURE, NON-COMPLIANT BALLOON DILATATION CATHETER. IF THIS IS REQUIRED, THE STENTED SEGMENT SHOULD BE CAREFULLY RECROSSED WITH A PROLAPSED GUIDE WIRE TO AVOID DISRUPTING THE STENT GEOMETRY. DEPLOYED STENTS SHOULD NOT BE LEFT UNDERDILATED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL RIGHT CORONARY ARTERY THAT HAD IN-STENT RESTENOSIS. ON (B)(6) 2012, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A STEMI (ST ELEVATED MYOCARDIAL INFARCTION) AND DURING THE TREATMENT AN IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED 2.5 X 18 MM XIENCE V WAS NOTICED. THE XIENCE V HAD BEEN SUCCESSFULLY IMPLANTED ON (B)(6) 2009 IN THE DISTAL RCA AND A 2.75 X 18 MM XIENCE V HAD BEEN IMPLANTED IN THE PROXIMAL RCA. THE IN-STENT RESTENOSIS WAS SUCCESSFULLY TREATED WITH A 2.75 X 18 MM NON-ABBOTT STENT AND POST DILATATION WAS PERFORMED WITH A 3.25 X 12 MM AND THEN A 3.5 X 12 MM NON-ABBOTT BALLOON CATHETERS. THE RESULT WAS SATISFACTORY WITH NO ADVERSE PATIENT EFFECTS. THE PHYSICIAN MEASURED THE DISTAL AREA OF THE TARGET LESION AND THE DIAMETER WAS 3.3 MM. BASED ON THE MEASUREMENT, THE PHYSICIAN CONCLUDED THAT THE 2.5 X 18 MM XIENCE V THAT WAS PLACE ON (B)(6) 2009 WAS TOO SMALL FOR THE VESSEL WHICH MIGHT HAVE CAUSED THE IN-STENT RESTENOSIS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S