BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 2111248 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02108
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 13, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED DUE TO PERSISTENT RIGHT SHOULDER AND RIGHT AXILLARY DISCOMFORT WITH ELEVATED TROPONIN (0.117 UNITS NOT PROVIDED). CARDIAC CATHETERIZATION WAS PERFORMED WITH LEFT RADIAL ARTERY ACCESS AND REVEALED AN 80% STENOSED AND 16MM LONG TARGET LESION LOCATED IN THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA) AT THE PROXIMAL EDGE OF A DISTAL STENT WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE RCA WAS PREVIOUSLY STENTED WITH UNKNOWN STENTS. A 6F MP1 GUIDE CATHETER WAS USED TO ENGAGE THE SVG TO THE RCA. TWO 0.014" NON-BSC GUIDE WIRES WERE ADVANCED TO THE SVG TO THE RCA, WITH ONE POSITIONED ANTEGRADE AND THE OTHER IN THE RETROGRADE PDA. ATTEMPTS TO ADVANCE THE RETROGRADE WIRE INTO THE NATIVE RCA WAS UNSUCCESSFUL. THE WIRE COULD NOT CROSS THE HIGH GRADE OSTIAL PDA NARROWING. KISSING BALLOON ANGIOPLASTY WAS PERFORMED WITH 2 2.5X20MM MAVERICK BALLOONS IN THE DISTAL SVG TO PDA ANASTOMOSIS WITH SEVERAL INFLATIONS REACHING MAXIMUM PRESSURE OF 10ATMS. ANGIOGRAPHY DEMONSTRATED SIGNIFICANT IMPROVEMENT IN LESION APPEARANCE AND RETROGRADE FLOW INTO THE RIGHT CORONARY SYSTEM. THE RCA WAS THEN ENGAGED WITH A 6F FR4 GUIDE CATHETER. A 0.014" NON-BSC GUIDE WIRE WAS DIRECTED INTO THE PDA. ATTEMPTS TO DELIVERY BALLOON CATHETERS ACROSS THE JAILED OSTIAL PDA STENOSIS WERE UNSUCCESSFUL. 2.5X20MM MAVERICK2 BALLOON WAS ADVANCED TO THE DISTAL RCA AND BALLOON ANGIOPLASTY WAS PERFORMED AT WHICH POINT A FLOW LIMITING VESSEL DISSECTION OCCURRED. IT WAS TREATED WITH PLACEMENT OF A 2.75X20MM TAXUS LIBERTE STENT OVERLAPPING A PREVIOUSLY DEPLOYED TAXUS STENT IN THE DISTAL RCA. FINAL ANGIOGRAPHY REVEALED 0% RESIDUAL STENOSIS IN THE DISTAL RCA, LESS THAN 30% RESIDUAL STENOSIS IN THE PL, NO CHANGE IN THE PDA LESION SEVERITY AND IMPROVED FLOW WITHIN THE DISTAL RCA CIRCULATION. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK228

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention