BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS MULTI-LINK CORONARY STENT SYSTEM

    MDR report key: 2200419 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05672
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    December 15, 2010
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT: ESTIMATED, AS IT WAS REPORTED TO HAVE OCCURRED IN (B)(6) 2010. FACTORS THAT MAY CONTRIBUTE TO STENT DAMAGE INCLUDE, BUT ARE NOT LIMITED TO, PROCESSING AND/OR HANDLING IN MANUFACTURING, HANDLING DURING PREPARATION FOR USE, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, PRODUCT SIZE SELECTION, SEVERE TORQUING OR KINKING OF STENT (MATERIAL STRESS/FATIGUE) OR INTERACTION WITH THE ACCESSORY DEVICES, LESION AND/OR ANATOMY. FATIGUE FROM CARDIAC DYNAMICS AND MOTION MAY ALSO CONTRIBUTE TO STENT DAMAGE DURING OR AFTER THE PROCEDURE. IN THIS CASE, THE STENT DAMAGE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, SUGGESTING THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. IT WAS REPORTED THE PATIENT HAD A FALLING ACCIDENT WHICH MAY HAVE CONTRIBUTED TO THE STENT DAMAGE; HOWEVER A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. DYSPNEA IS A SYMPTOM THAT COULD BE ASSOCIATED WITH MANY OTHER THINGS BESIDES THE CORONARY STENTS, SUCH AS THE OVERALL HEALTH AND CONDITION OF THE PATIENT OR MEDICATIONS THE PATIENT IS TAKING. A CONCLUSIVE CAUSE FOR THE PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE PART AND LOT NUMBERS WERE NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 1999, THE PATIENT HAD A 3.0 X 13 MM AND A 3.5 X 28 MM ACS MULTI-LINK STENT IMPLANTED IN THE LEFT ANTERIOR ASCENDING ARTERY. IN 2008 HE HAD TWO ADDITIONAL UNKNOWN STENTS IMPLANTED DUE TO RE-STENOSIS OF THE MULTILINK STENTS. THERE WAS NO ADVERSE EFFECT. IN (B)(6) 2010, THE PATIENT HAD AN ACCIDENT; HE FELL FROM APPROXIMATELY 10 FEET. SOON AFTERWARDS HE BEGAN EXPERIENCING SHORTNESS OF BREATH WITH EXERTION, SO HE WENT BACK TO HIS CARDIOLOGIST. AT THIS TIME HE UNDERWENT STENTING ON A NEW STENOSIS IN THE MID CIRCUMFLEX ARTERY WITH A 3.5 X 12 MM XIENCE V STENT. DURING THE PROCEDURE, THE PHYSICIAN CONFIRMED THAT ONE OF THE PREVIOUSLY IMPLANTED STENTS HAD BENT AND HE BALLOONED IT TO STRAIGHTEN IT OUT. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT IS DOING WELL AND IS ASYMPTOMATIC. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R STENT: ACS MULTI-LINK