BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3062013 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02339
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 29, 2012
    Report Date
    March 27, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION AND RESTENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED: THE DISTAL SIDE OF THE XIENCE V 3.0 X 12 MM STENT HAD A BORDERLINE LESION OF UNSPECIFIED SEVERITY. THERE WERE UNSPECIFIED MEDICATIONS GIVEN ONLY AS TREATMENT. THE SYMPTOMS RESOLVED WITHOUT AN ADVERSE PATIENT SEQUELA ON (B)(6) 2012. THE PATIENT WAS FOUND TO HAVE SOME PATHOLOGICAL CHANGES IN THE RENAL ARTERY; THEREFORE, HE STAYED LONGER IN THE HOSPITAL FOR RENAL ARTERY TREATMENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION RESOLVED ON (B)(6) 2012 AND THE EKG WAS DONE ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, TWO XIENCE V STENTS WERE IMPLANTED IN A DE NOVO, MID, LEFT ANTERIOR DESCENDING ARTERY (LAD) AND APPROXIMATELY ONE YEAR LATER, ON (B)(6) 2012, THE PATIENT EXPERIENCED CHEST PAINS (ANGINA) AND WAS HOSPITALIZED ON (B)(6) 2012. AN ANGIOGRAM WAS DONE WITH FINDINGS OF A SIDE BRANCH OCCLUSION OF THE 2ND DIAGONAL ARTERY. AN ELECTROCARDIOGRAM (EKG) WAS DONE AND THE PATIENT WAS DIAGNOSED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (STEMI). REPORTEDLY, THE MI WAS CAUSED BY THE XIENCE V STENT IN THE MID LAD COVERING OVER THE 2ND DIAGONAL SIDE BRANCH. THE DISTAL SIDE OF ONE OF THE XIENCE V STENTS HAD A BORDERLINE LESION OF UNSPECIFIED SEVERITY. THERE WERE UNSPECIFIED MEDICATIONS GIVEN ONLY AS TREATMENT. THE SYMPTOMS RESOLVED WITHOUT AN ADVERSE PATIENT SEQUELA ON (B)(6) 2012. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163490 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0070541

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R| S STENT: XIENCE V 3.0 X 23