BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4073228 · Received September 9, 2014

    Report

    Report Number
    2024168-2014-05776
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    June 20, 2012
    Report Date
    April 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION CONTINUED: AFTER MULTIPLE ATTEMPTS IT WAS ELECTED TO PROCEED WITH USE OF A ROTATIONAL ATHERECTOMY DEVICE TO BURR A PASSAGE THOUGH THE STENT WALL TO ALLOW ACCESS OF THE SEPTAL PERFORATOR. A 300 CM EXTRA-SUPPORT ROTAWIRE WAS ADVANCED THROUGH THE LAD STENT STRUTS INTO THE SEPTAL PERFORATOR. A 1.25 MM ROTA-BURR WAS THEN USED AT SPEEDS OF 177-180 RPM AND SLOWLY ADVANCED TO ALLOW GRADUAL CONTACT WITH THE STENT STRUTS. THIS THEN ALLOWED FOR PASSAGE OF A 1.5 X 8 MM NON-ABBOTT BALLOON WHICH WAS INFLATED TO 8 ATMOSPHERES. CONTRAST INJECTION WAS PERFORMED CONFIRMING NO FLOW BACK INTO THE LAD. DEFINITY CONTRAST THROUGH THE BALLOON CATHETER WAS DONE UNDER ECHOCARDIOGRAPHIC GUIDANCE AND CONFIRMED THAT THIS ARTERY SUPPLIED BLOOD FLOW TO THE MID AND BASAL PORTIONS OF THE SEPTUM. THEN THREE ML OF 98% DEHYDRATED ALCOHOL WAS INJECTED INTO THE SEPAL PERFORATOR. THE 1.5 X8 MM BALLOON WAS REMOVED AND SELECTIVE ANGIOGRAM WAS PERFORMED OF THE LAD CONFIRMING SUCCESSFUL ABLATION OF THE SEPTAL PERFORATOR. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS: GUIDE WIRE: PILOT; ROTA-WIRE. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. OCCLUSION IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. ARTICLE: "UNJAILING OF THE SEPTAL PERFORATOR USING A ROTATIONAL ATHERECTOMY DEVICE PRIOR TO ALCOHOL SEPTAL ABLATION IN A PATIENT WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY".

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE "UNJAILING OF THE SEPTAL PERFORATOR USING A ROTATIONAL ATHERECTOMY DEVICE PRIOR TO ALCOHOL SEPTAL ABLATION IN A PATIENT WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY" THE PATIENT WAS TO UNDERGO ALCOHOL SEPTAL ABLATION AS THE THERAPEUTIC OPTION OF CHOICE. THE PATIENT WAS BROUGHT TO THE CATH LAB AND FOUND TO HAVE A 70% PROXIMAL LEFT ANTERIOR DESCENDING (LAD) STENOSIS. INTRAVASCULAR ULTRASOUND (IVUS) AND FFR WERE PERFORMED AND THE LESION WAS CONSIDERED SIGNIFICANT AND A POTENTIAL CAUSE OF THE PATIENT'S ONGOING SYMPTOMS THEREFORE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH PLACEMENT OF A 3.5 X 23 XIENCE DRUG ELUTING STENT ON 06/18/2012. THE PATIENT RETURNED TO THE CATHETERIZATION SUITE TWO DAYS LATER FOR ALCOHOL SEPTAL ABLATION DUE TO CONTINUED SYMPTOMS, HOWEVER, THE DISTAL ASPECT OF STENT HAD NOW JAILED THE OSTIUM OF THE SEPTAL PERFORATOR. THE SEPTAL PERFORATOR WAS ACCESSED USING A PILOT GUIDE WIRE, HOWEVER, NEITHER A 1.5 X 6 MM NOR A 1.2 X 6 MM BALLOON WERE ABLE TO CROSS INTO THE SEPTAL PERFORATOR. IVUS OF THE LAD WAS THEN COMPLETED, FOLLOWED BY BALLOON ANGIOPLASTY OF THE LAD STENT, DESPITE THESE INTERVENTIONS A BALLOON WAS UNABLE TO CROSS INTO THE SEPTAL PERFORATOR PREEMPTING A DECISION TO STOP THE PROCEDURE. ON 08/30/2012, A SECOND ATTEMPT AT SEPTAL ABLATION WAS PERFORMED. MULTIPLE GUIDE WIRES WERE USED TO ENGAGE THE JAILED SEPTAL PERFORATOR HOWEVER A BALLOON WAS NOT ABLE TO CROSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553739 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R