BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2220998 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05925
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    January 3, 2008
    Report Date
    August 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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: STENT: TAXUS 2.5 X 12 MM, PROMUS 2.5 X 18 MM, XIENCE V 3.0 X 18 MM, 2.5 X 8 MM AND 2.75 X 28 MM. THE 2.5 X 8 MM XIENCE V AND THE 2.75 X 28 MM XIENCE V ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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 ON (B)(6) 2005, A NON-ABBOTT STENT WAS IMPLANTED IN THE FIRST DIAGONAL ARTERY. ON (B)(6) 2006, A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED IN THE FIRST DIAGONAL AND A VISION 2.75 X 28 MM STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). ON (B)(6) 2008, A PTCA WAS PERFORMED IN THE FIRST DIAGONAL ARTERY AND IN THE MLAD. ON (B)(6) 2008, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN, NECK PAIN AND SHORTNESS OF BREATH AND UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION WITH XIENCE V STENTING IN THE FIRST DIAGONAL ARTERY WITH ONE 2.5 X 8 MM STENT AND IN THE MLAD WITH ONE 2.75 X 28 MM STENT; BOTH LESIONS WERE RESTENOSED, PREVIOUSLY STENTED LESIONS. ON (B)(6) 2009, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH ONE PROMUS 2.5 X 18 MM STENT. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE MID RIGHT CORONARY ARTERY WITH ONE XIENCE V 3.0 X 18 MM STENT. ON THE (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR RECURRENT ANGINA AND UNDERWENT CORONARY ARTERY BYPASS GRAFTING OF THE DISTAL RCA, LAD (70% STENOSIS) AND THE DIAGONAL (70% STENOSIS). THE PATIENT WAS TRANSFUSED WITH FOUR UNITS OF BLOOD. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2011. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R| S