BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3301422 · Received August 21, 2013

    Report

    Report Number
    2024168-2013-05264
    Event Type
    Death
    Date Received
    August 21, 2013
    Date of Event
    January 1, 2006
    Report Date
    July 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE ESTIMATED. DATE OF EVENT ESTIMATED AS (B)(6) 2006, 12 MONTHS AFTER ESTIMATED STENT IMPLANTATION. DATE OF IMPLANT ESTIMATED AS (B)(6) 2005, 1ST POTENTIAL DAY THAT A 2ND GENERATION (EES) WAS IMPLANTED. THERAPY DATE ESTIMATED. ARTICLE REVIEW DATE IS (B)(4) 2013. CONCOMITANT PRODUCT: STENT: XIENCE V, XIENCE PRIME, PROMUS. (B)(4) - NO PRE-DILATATION, INDICATION FOR USE. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. IT SHOULD BE NOTED THAT THE IFU STATES THAT THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. ADDITIONALLY, THE IFU INSTRUCTS THE PHYSICIAN TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. 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. THE OTHER XIENCE AND PROMUS DEVICES REFERENCED ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ARTICLE: HELDER DORES, MD, LUIS RAPOSO, MD, RUI CAMPANTE TELES, MD, CARINA MACHADO, MD, SILVIO LEAL, MD, PEDRO ARAUJO GONCALVES, MD, HENRIQUE MESQUITA GABRIEL, MD, MANUEL SOUSA ALMEIDA, MD, MIGUEL MENDES, MD. (J INV CARD(1042-3931) 2013 25(7):330-6 ): "STENT THROMBOSIS WITH SECOND- VERSUS FIRST-GENERATION DRUG-ELUTING STENTS IN REAL-WORLD PERCUTANEOUS CORONARY INTERVENTION: ANALYSIS OF 3806 CONSECUTIVE PROCEDURES FROM A LARGE-VOLUME SINGLE-CENTER PROSPECTIVE REGISTRY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT A SINGLE-CENTER STUDY IDENTIFIED A TOTAL OF 1418 PATIENTS, OF WHICH 571 PATIENTS RECEIVED ONE OR MORE EVEROLIMUS ELUTING STENTS (EES), INCLUDING XIENCE V, XIENCE PRIME, AND PROMUS STENTS BETWEEN 2005 AND 2010, 35 PATIENTS RECEIVED A COMBINATION OF BOTH EES AND NON-ABBOTT ZOTAROLIMUS ELUTING STENTS (ZES) BETWEEN 2005 AND 2010, WITH THE REMAINING 812 PATIENTS RECEIVING NON-ABBOTT ZESS BETWEEN JANUARY 2003 AND DECEMBER 2010; THE FOLLOWING PERCENTAGE OF PATIENTS RECEIVED STENTS IN THE FOLLOWING CORONARY VESSELS AND HAD THE FOLLOWING LESION CHARACTERISTICS: LEFT MAIN (2.8%), LEFT ANTERIOR DESCENDING (42.5%), LEFT CIRCUMFLEX (25%), RIGHT CORONARY ARTERY (27.3%), GRAFTS (1.7%), IN-STENT RESTENOSIS OF AN UNSPECIFIED STENT (6.6%), MODERATE TO SEVERE LESION CALCIFICATION (14.6%). EACH STENT WAS DEPLOYED AT AN AVERAGE PRESSURE OF 14 ATMOSPHERES. TWENTY-FIVE PERCENT OF THE PATIENTS RECEIVED THE STENTS VIA DIRECT STENTING. CLINICAL OUTCOMES 12 MONTHS POST-PROCEDURE, FOR PATIENTS WHO RECEIVED XIENCE V, XIENCE PRIME, AND/OR PROMUS STENTS WERE AS FOLLOWS: 3.5 % ALL-CAUSE MORTALITY (DEATH). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404906 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death