BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3841001 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03467
    Event Type
    Death
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 9, 2014
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE ANATOMY; THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED FOR INVESTIGATION, THEREFORE FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. IN THIS CASE, THERE WERE NO REPORTED DEVICE MALFUNCTIONS OR PRODUCT DEFICIENCIES. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE REPORTED PATIENT EFFECTS OF DEATH, ARTERIAL PERFORATION AND HYPOTENSION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM CE, INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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). A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DEPLOYMENT ISSUES REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014 USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE NON-CALCIFIED, NON-TORTUOUS, DE NOVO MID CIRCUMFLEX ARTERY A 4.0 X 28 MM XIENCE V STENT WAS IMPLANTED AND A 2.75 X 28 MM XIENCE PRIME WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). IT WAS NOTED THAT WITHIN A HALF HOUR POST STENTING PROCEDURE THE PATIENTS BLOOD PRESSURE DROPPED DRASTICALLY AND AN ANGIOGRAPHY SHOWED A PERFORATION AT THE SITE OF THE XIENCE V IN THE CIRCUMFLEX; THE PATIENT EXPIRED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED VIA CINE REVIEW BY AN ABBOTT SPECIALIST WHICH REVEALED THERE ARE TWO SIGNIFICANT LESIONS IN THE MID LCX. JUST PROXIMAL TO THE FIRST LESION, THE VESSEL APPEARS SOMEWHAT ANEURISMAL. A BALLOON IS POSITIONED ACROSS THE DISTAL LESION, OCCLUDING DISTAL FLOW. THE BALLOON IS INFLATED. DURING INFLATION, THERE IS DYE HANG-UP AT THE ANEURYSM SITE. BALLOON INFLATIONS ARE PERFORMED ACROSS THE PROXIMAL LESION. A STENT IS IMPLANTED OVER THE LESIONS AND THE ANEURYSM. THE STENT DOES NOT APPEAR TO BE EVENLY EXPANDED AS THERE IS SOME 'POUCHING' AT THE ANEURYSM. A LESION IN THE MID-RCA IS BALLOONED. A DISSECTION OCCURS. A STENT IS DEPLOYED PROXIMAL TO MID-RCA, COVERING THE DISSECTION. THERE IS A PERFORATION AT THE AREA OF THE STENTED ANEURYSM. IT IS CONCLUDED THAT THE IMAGES ARE CONSISTENT WITH THE INCIDENT DESCRIPTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318445 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2050241

    Patients

    Seq Age Sex Outcome Treatment
    1 Death STENT: 2.75 X 28 MM XIENCE PRIME