BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3821796 · Received May 20, 2014

    Report

    Report Number
    2024168-2014-03198
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    March 20, 2013
    Report Date
    April 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: BALANCE MIDDLEWEIGHT (BMW) 190 CM; GUIDE CATH: JL3.5, 6F; SHEATH: TERUMO TRANSRADIAL 6F. THE REPORTED DISSECTION IS LISTED IN THE INSTRUCTIONS FOR USE (IFU), IN THE ADVERSE EFFECTS SECTION AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. CINE REVIEW WAS PERFORMED BY AN ABBOTT VASCULAR PHYSICIAN/CLINICAL SPECIALIST. THE REVIEWER NOTED THAT THE FIRST FILMS DATED (B)(6) 2013 ARE DIAGNOSTIC PICTURES ONLY AND SHOW LARGE DOMINANT RIGHT CORONARY ARTERY WITH 40% MID-SEGMENT STENOSIS, AND LEFT ANTERIOR DESCENDING (LAD) WITH TANDEM TUBULAR 40% PROXIMAL AND 50-60% MID-SEGMENT LESIONS, AND LEFT CIRCUMFLEX WITH 50% LESION IN THE LARGE 1ST OBTUSE MARGINAL. THE NEXT FILMS ARE DATED (B)(6) 2013 AND SHOW THAT PATIENT RETURNED FOR PERCUTANEOUS CORONARY INTERVENTION OF THE LAD. THE MID-SEGMENT STENOSIS IS PRE-DILATED RESULTING IN 40% RESIDUAL AND A LINEAR DISSECTION. A LONG METALLIC STENT IS PLACED AT THIS LESION AND POST-DILATED WITH NICE RESULT AND GOOD FLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2013, WAS TO TREAT DE NOVO LESIONS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. PRE-DILATATION OF THE MID LAD WAS PERFORMED WITH A 2.5 X 15 MM TREK, PRIOR TO DEPLOYMENT OF A 2.5 X 33 MM XIENCE PRIME LL AT 10 ATMOSPHERES (ATM). THE PROXIMAL LAD WAS PRE-DILATED WITH A 2.5 X 15 MM NC TREK, REDUCING THE STENOSIS TO LESS THAN 40%, PRIOR TO DEPLOYMENT OF THE 2.5 X 18 MM IMPLANT AT 8 ATM. POST-DILATATION WAS PERFORMED WITH A 2.75 X 12 MM NC TREK UP TO 16 ATM. THERE WERE NO COMPLICATIONS THROUGHOUT THE PROCEDURE. ON (B)(6) 2014, THE PATIENT COMPLAINED OF SLIGHT CHEST TIGHTNESS AND AN ANGIOGRAM SHOWED >40% RESTENOSIS AT THE SITE OF THE 2.5 X 18 MM IMPLANT. THE MID TO DISTAL LAD WITH THE XIENCE PRIME REMAINS OKAY. CURRENTLY NO FURTHER INTERVENTION HAS BEEN DONE. THE PATIENT REMAINS ON CURRENT MEDICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. CINE REVIEW REVEALED THAT DURING PRE-DILATATION OF THE MID-SEGMENT STENOSIS WITH THE 2.5 X 15 MM TREK BALLOON, A LINEAR DISSECTION OCCURRED. THE DISSECTION WAS TREATED WHEN THE XIENCE PRIME STENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298814 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2022861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention