BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 1895024 · Received November 5, 2010

    Report

    Report Number
    3004742046-2010-00522
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. BASED ON THE REPORTED INFORMATION, THE LESION WAS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. FURTHERMORE, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE DURING THE PROCEDURE, THIS CAN CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING INFLATION. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND PRODUCT SIZE SELECTION. IN THIS CASE, IT MAY BE POSSIBLE THAT THE DISSECTION OCCURRED AS A RESULT OF THE REPORTED BALLOON RUPTURE. THE DISSECTION WAS REPORTED TO HAVE BEEN TREATED WITH A 8 X 20 XACT STENT TO COVER THE DISSECTION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. OVERALL, THE REPORTED DISSECTION APPEARS TO BE THE RESULT OF THE BALLOON RUPTURE AND THE BALLOON RUPTURE APPEARS TO BE THE RESULT OF THE HEAVILY CALCIFIED LESION SITE. HOWEVER, WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL, THAT DURING PREDILATATION OF THE HEAVILY CALCIFIED LESION IN THE TARGET LEFT INTERNAL CAROTID ARTERY, THE VIATRAC BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMOSPHERES. THE ENTIRE VIATRAC BALLOON WAS COMPLETELY REMOVED FROM THE PT. A DISSECTION WAS IDENTIFIED PROXIMAL TO THE TARGET LESION. THE PHYSICIAN COMMENTED THAT THE BALLOON RUPTURE WAS THE PROBABLE CAUSE OF THE DISSECTION. THE 8 - 6 X 40 XACT WAS IMPLANTED IN THE TARGET LESION FOLLOWED BY THE IMPLANTATION OF THE 8 X 20 XACT BAILOUT STENT IN THE LEFT COMMON CAROTID TO COVER THE DISSECTION. THE PT WAS DISCHARGED HOME THE FOLLOWING DAY. THERE WERE NO ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 0071351

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention STENT: XACT ((B)(4), LOT# 0033161)| LOT# 0082351)| HEPARIN| EMBOLIC PROTECTION: EMBOSHIELD NAV 6 ((B)(4)