BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK 8

    MDR report key: 1884702 · Received October 25, 2010

    Report

    Report Number
    2024168-2010-02253
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT CAN CONTRIBUTE TO STENT DAMAGE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, REMOVAL OF THE PROTECTIVE SHEATH, HANDLING OF THE PRODUCT, OR INTERACTION OF THE SDS WITH ACCESSORY DEVICES OR ANATOMY. AS THERE WAS NO REPORTED DAMAGE NOTED TO THE STENT PRIOR TO USE, IT IS LIKELY THE STENT DAMAGE OCCURRED DURING USE. IT WAS REPORTED THE STENT WAS POST DILATED; HOWEVER, THE STENT STRUTS FAILED TO APPOSE TO THE VESSEL WALL; THEREFORE ANOTHER STENT WAS IMPLANTED. IT WAS REPORTED THE XIENCE PRIME WAS DIRECT STENTED IN THE LESION. IT SHOULD BE NOTED IN THE INSTRUCTIONS FOR USE (IFU) IT STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. IT IS POSSIBLE THE FAILURE TO PRE-DILATE THE LESION COULD HAVE CAUSED DAMAGE TO THE STENT DURING ADVANCEMENT; HOWEVER, THIS COULD NOT BE CONFIRMED AND A CONCLUSIVE CAUSE FOR THE REPORTED STENT DAMAGE OR DIFFICULTY DEPLOYING THE STENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4) - NO PREDILATATION, (B)(4). THE STENT REMAINS IN THE PATIENT. THE STENT DELIVERY SYSTEM WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS 3500A REPORT WAS FILED IN ERROR. THE EVENT DID NOT INVOLVE A MULTI-LINK 8 OR ANY DEVICE APPROVED OR SIMILAR TO A DEVICE APPROVED IN THE U.S.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PART NUMBER WAS INCORRECTLY REPORTED BY THE CUSTOMER AS A MULTI-LINK 8. THEREFORE, THE PART HAS BEEN CHANGED FROM A MULTI-LINK 8 ((B)(4)) TO A RX XIENCE PRIME ((B)(4)). ADDITIONALLY, THE XIENCE PRIME IS ON CLINICAL TRIAL HERE IN THE U.S.; THEREFORE, A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE LEFT ASCENDING DIAGONAL (LAD) AND WAS CROSSED WITH A BMW WIRE. THE DECISION WAS MADE TO DIRECT STENT THE LESION. AFTER THE STENT WAS DEPLOYED, IT WAS NOTICED THAT DISTALLY A PART OF THE STENT STRUT WAS FLARED; THEREFORE, POST DILATATION WAS PERFORMED; HOWEVER, THIS FAILED TO APPOSE THE FLARED PART OF THE STENT TO THE VESSEL WALL. FEARING THAT A DISSECTION COULD OCCUR AT A LATER DATE BECAUSE OF THE FLARED STRUT ANOTHER 3.5 X 12 MM XIENCE V STENT WAS IMPLANTED. THE PATIENT WAS KEPT FOR OBSERVATION FOR TWO DAYS POST PROCEDURE AND WAS STABLE WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM NIQ AV-CLONMEL NA 0041441

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention GUIDE CATH: 6F JL| GUIDE WIRE: BMW| INFLATION: ABT| STENT: XP: 3.5 X 23| DILATATION CATHETER: VOYAGER NC