BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2132651 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04299
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    March 7, 2011
    Report Date
    May 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT MEDICAL PRODUCTS: DILATATION CATHETER: GUIDE WIRE: RUNTHROUGH; GUIDE CATH: 6 FR TYPE M. (B)(4): PATIENT SELECTION. A CINE WITH 2 IMAGES OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL. THE REVIEWER NOTED THE FIRST IMAGE SHOWS A DISCRETE HAZINESS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE IS CONTRAST IN THE VESSEL, THUS A STENT SHADOW CANNOT BE DISCERNED. HOWEVER, THE AREA DOES HAVE A STENT-LIKE APPEARANCE. THE SECOND IMAGE IS AN IVUS PICTURE. THERE ARE STENT STRUTS VISIBLE FROM 1 O'CLOCK TO 7 O'CLOCK. THERE IS MATERIAL (PLAQUE OR THROMBUS) IN THE LUMEN. THE REVIEWER CONCLUDED THAT AS THE IMAGES ARE NOT LIVE RUNS, IT IS VERY DIFFICULT TO REACH A CONCLUSION OR TO IDENTIFY A POSSIBLE EXPLANATION FOR THE EVENTS THAT WERE REPORTED. IF THE PROXIMAL LAD WAS STENTED, THEN THE CINE IMAGE WOULD CONFIRM AN IRREGULARITY/HAZINESS IN THE PROXIMAL LAD EVEN THOUGH THERE IS COMPLETE CONTRAST FILLING IN THE DISTAL VESSEL. AS THE IVUS IS NOT LIVE IT CAN ONLY BE ASSUMED THAT THE FULL RUN WOULD SHOW THE STENT STRUTS FROM 1 O'CLOCK TO 7 O'CLOCK AND CONFIRM FULL STENT EXPANSION AND NO STENT DAMAGE. FACTORS THAT CAN CONTRIBUTE TO THE STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE DURING USE OF THE PRODUCT, AN INTERACTION WITH THE PATIENT ANATOMY AND/OR PREVIOUSLY IMPLANTED STENTS, POST DILATATION TECHNIQUE, OR UNDERSIZING OF THE VESSEL. THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE AIDED THE INVESTIGATION. THERE WAS NO REPORT OF ANY DAMAGE TO THE SDS OR STENT IMPLANT OBSERVED PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTY EXPERIENCED. THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATE THE PROMUS IS CONTRAINDICATED FOR USE IN PATIENTS WHO HAD RECENT ACUTE MYOCARDIAL INFARCTION (AMI) OR WHO HAVE NOT NORMALIZED THE CARDIAC ENZYME LEVELS AFTER AMI. ADDITIONALLY, THROMBOSIS IS LISTED IN THE IFU AS A KNOWN ADVERSE PATIENT EFFECT WITH CORONARY STENTING. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR DIFFICULT TO DEPLOY FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. ALL SDS ARE CONFIRMED BY VARIOUS QUALITY CHECKS TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS, INCLUDING PROPER BALLOON DIMENSIONS, AND PROPER STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER INFLATION AND STENT DEPLOYMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCT AND WAS TREATED WITH THROMBECTOMY, NON-ABBOTT STENT IMPLANT IN THE FIRST DIAGONAL FOLLOWED BY A 3.5 MM X 18 MM XIENCE V STENT IMPLANTED IN THE PROXIMAL LEFT DESCENDING ARTERY. POST DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND THE PROCEDURE WAS NOTED AS HAVING GOOD EXPANSION OF THE STENT. THIRTEEN DAYS POST STENTING, THE PATIENT HAD A ONE MONTH FOLLOW UP AND IT WAS NOTED THAT THE STENT HAD A PROXIMAL UNSPECIFIED OCCLUSION. THERE WAS NO PERCUTANEOUS TRANSLUMINAL TREATMENT TO THE PATIENT, HOWEVER, MEDICATION WAS GIVEN. IT WAS SUSPECTED THAT THROMBOSIS MIGHT HAVE OCCURRED DUE TO PART OF THE STENT NOT BEING FULLY OPPOSED TO THE VESSEL; THAT LAMINAR AIRFLOW OF BLOOD OCCURRED. THIRTY DAYS POST PROCEDURE, AN ANGIOGRAPHY CONFIRMED THE OCCLUSION REMAINED IN THE STENT PROXIMALLY. DURING THE TREATMENT OF THE OCCLUSION/POSSIBLE THROMBOSIS, ASPIRATION WAS ATTEMPTED BUT THE OCCLUSION WAS NOT REMOVED. A BALLOON ANGIOPLASTY WAS PERFORMED WITH A NON-ABBOTT BALLOON AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED GOOD BLOOD FLOW IN THE STENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0072941

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention