BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 6988091 · Received October 30, 2017

    Report

    Report Number
    3007210870-2017-00009
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    August 24, 2017
    Report Date
    September 30, 2017
    Manufacturer
    TRYTON MEDICAL, INC.
    Product Code
    MAF
    PMA / PMN Number
    P150039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE: NO CODE AVAILABLE FOR RESTENOSIS. RESULTS CODE: EXAMINATION OF THE LOT HISTORY RECORD SHOWED THAT THE LOT PASSED ALL ACCEPTANCE CRITERIA (NOTE: DESCRIPTION PROVIDED HERE BECAUSE NO RELEVANT RESULTS CODE IS AVAILABLE).

    Description of Event or Problem · 1

    RESTENOSIS 4 MONTHS FOLLOWING IMPLANTATION [OF TRYTON SIDE BRANCH STENT] NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT DAMAGE. TREATED WITH PCI REVASCULARIZATION. RESTENOSIS RESOLVED. THE FOLLOWING DETAILS WERE PROVIDED REGARDING THE INDEX PROCEDURE AND SUBSEQUENT EVENT: DATE OF [INDEX] PROCEDURE: (B)(6) 2017. MV: LAD PROXIMAL; SB: LCX PROXIMAL. MEDINA CLASSIFICATION: 1,1,1. LESION ANGLE: MEDIUM >30O. OVERALL TIMI FLOW [PRE-PROCEDURE]: 3. LESION CLASS ACCORDING ACC/AHA: B2. CALCIFICATION: NO, VESSEL TORTUOSITY: NO, THROMBUS PRESENT: NO. GUIDING CATHETER: 7 FR. PRE-DILATION: 1 BALLOON. POST-DILATATION: 4 BALLOONS. TRYTON DEVICE: T5-3035-151, LOT T032515303516. MV STENT: SYNERGY 3.50 X 24.00 MM. ADDITIONAL STENTS: ORSIRO AT 1ST DIAGONAL, 2.50 X 28.00 MM. WAS LESION ON SB PRE-DILATED? YES. DEPLOYMENT AT INTENDED SITE? YES. WAS IT EASY TO PASS THE TRYTON STENT WITH THE MB STENT? YES. WAS THE TRYTON STENT POST DILATED BEFORE INSERTION OF THE MB STENT? YES. POST DILATION ON SIDE BRANCH WIRE: YES. POST DILATION ON MAIN BRANCH WIRE: YES. KISSING BALLOON PERFORMED? YES. DISSECTION OBSERVED? NO. TIMI FLOW POST-PROCEDURE: 3. DID ANY TECHNICAL COMPLICATION OCCUR DURING THE PROCEDURE? NO. DATE OF EVENT: (B)(6) 2017. REPEAT REVASCULARIZATION: YES. ISCHEMIC STATUS: STABLE ANGINA; CCS II. TYPE OF REVASCULARIZATION: PCI. REPEAT REVASCULARIZATION IS BASED ON: ANGINAL STATUS, REPEAT ANGIOGRAPHY. IS TARGET LESION INVOLVED? YES. % DIAMETER STENOSIS: SB 99%; MB 0%. BLEEDING: NO. OTHER: YES; (THE FOLLOWING TO ITEMS WERE CHECKED.) REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION. RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT TO BODY FUNCTION. RELATIONSHIP TO DEVICE: HIGHLY PROBABLE. RELATIONSHIP TO PROCEDURE (IMPLANTATION): HIGHLY PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767319 TRYTON SIDE BRANCH STENT BARE METAL CORONARY STENT MAF TRYTON MEDICAL, INC. T032515303516

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ACE INHIBITORS| ASPIRIN| ORSIRO STENT| STATINS| SYNERGY STENT| SYNERGY STENT (ADDITIONAL IN LCX)