BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2193393 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05561
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CINE IMAGES REVIEW WAS COMPLETED AND THE REVIEWER NOTED TIGHT STENOSIS IN THE MID SECTION OF A HIGHLY CALCIFIED RIGHT CORONARY ARTERY (RCA). TWO BALLOON MARKERS ARE POSITIONED AROUND THE LESION. (THERE ARE NO IMAGES OF ANY INFLATIONS.) A STENT IS THEN POSITIONED OVER THE LESION AND DEPLOYED. SEVERAL RUNS SHOW POST-DEPLOYMENT. A DISSECTION IS THEN VISIBLE IN THE OSTIUM AND PROXIMAL VESSEL. THE DISSECTION DOES NOT EXTEND TO THE PROXIMAL STENT EDGE. A SECOND STENT IS THEN IMPLANTED IN THE RCA OSTIUM, EXTENDING TO AND OVERLAPPING THE PROXIMAL EDGE OF THE INITIAL STENT. THERE IS STILL A DISSECTION PLANE VISIBLE AT THE OSTIUM. THIS IS TREATED BY IMPLANTING A SHORTER STENT IN THE OSTIUM (OVERLAPPING). THE REVIEWER CONCLUDED THAT A DISSECTION OCCURRED IN THE OSTIUM OF THE RCA AFTER IMPLANT OF A STENT IN THE MID VESSEL. THE DISSECTION WAS MOST LIKELY NOT ASSOCIATED WITH THE STENT IMPLANT BUT RATHER, FROM SOME OTHER SOURCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MILDLY TORTUOUS AND CALCIFIED PROXIMAL RIGHT CORONARY ARTERY, A 3.5 X 15 XIENCE V RX STENT SYSTEM WAS ADVANCED AND THE STENT DEPLOYED. DURING THE ANGIOPLASTY, A DISSECTION AT THE DISTAL EDGE OF THE STENT OCCURRED. THE DISSECTION WAS COVERED BY A 3.0 X 15 XIENCE V STENT SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR BEING FILED, A CINE CD OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY A CLINICAL SPECIALIST.

    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 0070541

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention