BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1252409 · Received December 3, 2008

    Report

    Report Number
    2024168-2008-01268
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. DISSECTION IS A POTENTIAL PATIENT ADVERSE EFFECT OF CORONARY DILATATION PROCEDURE, AND IS LISTED IN THE RX VOYAGER INSTRUCTIONS FOR USE (IFU) DISSECTION CAN BE INFLUENCED BY DEVICE SIZE SELECTION, LESION CHARACTERISTICS, OR PROCEDURAL TECHNIQUE. ALTHOUGH A DISSECTION HAD OCCURRED DURING THE PROCEDURE, THERE DID NOT APPEAR TO BE AN ISSUE WITH THE BALLOON DILATATION CATHETER. A CONCLUSIVE ROOT CAUSE FOR THE DISSECTION COULD NOT BE DETERMINED. THE TWO RX XIENCE V STENTS ARE REPORTED UNDER MFR #2024168-2008-01124.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT DURING THE INDEX PROCEDURE AFTER PRE-DILATING THE LESION WITH AN RX VOYAGER BALLOON, A DISSECTION OCCURRED PROXIMAL TO THE LESION AND JUST BEYOND THE LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO XIENCE V STENTS WERE USED TO TREAT THE DISSECTION; HOWEVER, THERE WAS PLAQUE SHIFT AFTER THE STENTS WERE DEPLOYED. THE LESION WAS A 99% STENOSED LESION IN THE MID LAD. THE PLAQUE SHIFTED INTO THE 2ND DIAGONAL. PRE STENOSIS OF THE 2ND DIAGONAL WAS 0% AFTER STENTING THE MID LAD, THE 2ND DIAGONAL STENOSIS WAS 95% DUE TO THE PLAQUE SHIFT. THE PATIENT WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DUE TO THE PLAQUE SHIFT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention (1009541-28/8043061)| 3.5 X 18 MM (1009542-18/UNK)| STENT: RX XIENCE V STENTS 3.0 X 28 MM