BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1899467 · Received November 5, 2010

    Report

    Report Number
    2024168-2010-02376
    Event Type
    Death
    Date Received
    November 5, 2010
    Date of Event
    September 8, 2010
    Report Date
    February 12, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEATH AND PERFORATION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTION FOR USE. A CONCLUSIVE CAUSE FOR THE REPORTED PT 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. THE JOSTENT GRAFTMASTERS, AND THE XIENCE V PART #1009542-15, LOT# 0052741 INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THE PATIENT EFFECTS HOWEVER THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERFORATION WAS CAUSED BY SIMULTANEOUS DEPLOYMENT OF TWO (2) XIENCE V 3.5 X 15 STENTS ATTEMPTING TO RECONSTRUCT THE DISTAL LEFT MAIN BIFURCATION. THE PHYSICIAN STATED THAT "HONESTLY, I BELIEVE IF I HAD CHOSEN 3.0 MM STENTS INSTEAD OF 3.5 MM AND DEPLOYED AT A LOWER ATMOSPHERE, THE OUTCOME WOULD HAVE BEEN DIFFERENT. THE 4.0 X 12 GRAFTMASTER WAS BEING USED FIRST TO SEAL THE PERFORATION; HOWEVER, IT DISLODGED FROM THE BALLOON AND WAS THEN STENTED AGAINST THE VESSEL WALL WITH THE 4.0 X 19 GRAFTMASTER; HOWEVER, THE PERFORATION WOULD NOT SEAL, AND THERE WAS NO FLOW DISTAL TO THE LEFT MAIN. THE PHYSICIAN DID NOT WANT TO INTERVENE ANY FURTHER. THE PATIENT DIED. THE PATIENT WAS HIGH RISK AND HAD INITIALLY DECLINED SURGERY. NO ADD'L INFO WAS PROVIDED.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: THE PATIENT UNDERWENT PLANNED LEFT MAIN CORONARY INTERVENTION ON (B)(6) 2010, HAVING UNDERGONE DIAGNOSTIC CORONARY ANGIOGRAPHY AT ANOTHER HOSPITAL SEVERAL DAYS EARLIER. DURING THE CORONARY INTERVENTION, FOLLOWING DEPLOYMENT OF TWO DRUG ELUTING STENTS TO RECONSTRUCT THE LEFT MAIN BIFURCATION, THE PATIENT SUSTAINED A PERFORATION OF THE LEFT MAIN CORONARY ARTERY, ASSOCIATED WITH HEMODYNAMIC COLLAPSE. VASOPRESSOR THERAPY WAS BEGUN AND SUBXIPHOID PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE HEMOPERICARDIUM. DUE TO ONGOING HEMORRHAGE FROM THE LEFT MAIN CORONARY ARTERY, AN ATTEMPT WAS MADE TO SEAL THE PERFORATION USING A GRAFTMASTER STENT. WHILE ATTEMPTING TO POSITION THE GRAFTMASTER STENT IN THE LEFT MAIN CORONARY ARTERY, THE STENT LOOSENED FROM ITS DEPLOYMENT BALLOON AND EMBOLIZED TO THE MID PORTION OF THE LEFT ANTERIOR DESCENDING ARTERY. A SECOND GRAFTMASTER STENT WAS THEN ADVANCED AND DEPLOYED IN THE LEFT MAIN CORONARY ARTERY, BUT THE PATIENT BECAME ASYSTOLIC NONETHELESS, AND EXPIRED.

    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 NA 0052741

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death XIENCE V PART# 1009542-15, LOT #0052741| JOSTENT GRAFTMASTER, PART# 12746-19, LOT# UNKNOWN