BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX PENTA CORONARY STENT SYSTEM

    MDR report key: 2133930 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04345
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    December 16, 2010
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    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. THE XIENCE V IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. (B)(6). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS IS LISTED IN THE PENTA INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT WHICH MAY RESULT FROM CORONARY STENTING. IT WAS REPORTED THAT THE PENTA WAS IMPLANTED IN THE SAPHENOUS VEIN GRAFT, WHICH IS NOT A CORONARY ARTERY. THE PENTA IFU STATES ITS PURPOSE OF USE/INDICATION AS: PATIENTS WITH SYMPTOMATIC ISCHMEMIC HEART DISEASE DUE TO DE NOVO OR RESTENOTIC CORONARY ARTERY LESIONS WHICH INCLUDE ACUTE CLOSURE OR THREATENED CLOSURE DUE TO SUB OPTIMAL INTERVENTION RESULT. IN THIS CASE, IT DOES NOT APPEAR THAT THE REPORTED USE IN AN INCORRECT ANATOMY CONTRIBUTED TO THE REPORTED PATIENT EFFECTS; HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MORE THAN TEN YEARS AGO, THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFTING, BYPASSING THE AORTA TO THE LEFT CIRCUMFLEX (LCX). IN (B)(6) 2005, THE SAPHENOUS VEIN GRAFT (SVG) STENOSED AND A 4.0 X 18 PENTA STENT WAS IMPLANTED. ON (B)(6) 2010, THE PATIENT UNDERWENT A STENTING PROCEDURE IN THE OBTUSE MARGINAL, DISTAL AND PROXIMAL (LCX) WITH TWO NON-ABBOTT STENTS AND ONE 2.5 X 18 XIENCE V STENT. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN. THE CORONARY ANGIOGRAM PERFORMED SHOWED THE ENTIRE LENGTH OF THE SAPHENOUS VEIN GRAFT FROM OSTIUM ON, OCCLUDED WITH THROMBOSIS WHICH A BALLOON ANGIOPLASTY WAS PERFORMED IN THE SVG. THE THROMBOSIS WAS ASPIRATED AND BALLOON ANGIOPLASTY WAS PERFORMED. ON (B)(6) 2010, CORONARY ANGIOGRAM PERFORMED SHOWED THROMBOSIS. THE PATIENT WAS SCHEDULED TO UNDERGO UNKNOWN OPERATION IN (B)(6) 2011. THE PHYSICIANS ASSUMES THIS EVENT MAY HAVE BEEN A VERY LATE THROMBOSIS INFLICTED BY THE PENTA OR A (SUBACUTE) THROMBOSIS CAUSED BY THE NON-ABBOTT STENTS. ADDITIONALLY, HE COMMENTED THAT DURING THE PROCEDURE PERFORMED ON (B)(6) 2010, THE OSTIUM OF THE SVG MIGHT HAVE BEEN DAMAGED AS IT CAME IN CONTACT WITH THE GUIDING CATHETER. HOWEVER, THE POSSIBILITY OF THE THROMBOSIS HAVING OCCURRED DUE TO THE XIENCE V STENT IS LOW. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX PENTA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ENDEAVOR 3.0 X 15 AND 3.0 X 12XIENC V 2.5 X 18