BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 4090721 · Received September 15, 2014

    Report

    Report Number
    2024168-2014-05941
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RE-INSERTION. CONCOMITANT PRODUCTS: GUIDE CATHETER: 7FR; GUIDE WIRE: FLOPPY; STENT: 2.75 X 12 MM MULTILINK VISION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IT WAS REPORTED THAT THE GRAFTMASTER WAS RE-INSERTED INTO THE PATIENT ANATOMY. THE GRAFTMASTER INSTRUCTIONS FOR USE STATES: THIS DEVICE IS INTENDED FOR SINGLE-USE ONLY; DO NOT REUSE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE MULTILINK VISION REFERENCED IS BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED VIA USER MEDWATCH RECEIVED STATES: "PERFORATION OF THE CIRCUMFLEX ARTERY OCCURRED DURING PTCA. PT. BECAME HYPOTENSIVE, PERICARDIOCENTESIS PERFORMED AND JO STENT INSERTION ATTEMPTED. DURING PROCEDURE THE STENT BROKE OFF THE CATHETER. MANUFACTURER RESPONSE FOR CORONARY STENT, GRAFTMASTER CORONARY STENT GRAFT SYSTEM (PER SITE REPORTER) - UNKNOWN. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? CONTROL OF BLEEDING AT PERFORATION SITE WITH JO STENT. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, NON-TORTUOUS, CIRCUMFLEX ARTERY USING A 7 FR GUIDE CATHETER, PREDILATATION WITH A 2.0 X 12 MM UNSPECIFIED BALLOON DILATATION CATHETER WAS COMPLETED AND THE 2.75 X 12 MM VISION STENT WAS DEPLOYED; HOWEVER, A VESSEL PERFORATION PROXIMAL TO THE STENT WAS NOTED. A 2.80 X 19 MM GRAFTMASTER COVERED STENT WAS ATTEMPTED, BUT COULD NOT CROSS THE VESSEL AND WAS REMOVED FROM THE ANATOMY. ADDITIONAL 2.0 X 12 MM UNSPECIFIED BALLOON DILATATION OF THE VESSEL WAS PERFORMED AND THE SAME 2.80 X 19 MM GRAFTMASTER WAS AGAIN ATTEMPTED, BUT COULD NOT BE ADVANCED IN THE HEAVILY CALCIFIED VESSEL. ADDITIONAL GUIDE CATHETER SUPPORT WAS DESIRED AND BOTH THE GUIDE CATHETER AND UNSPECIFIED FLOPPY GUIDE WIRE WERE REMOVED WITHOUT ISSUE. THE VESSEL WAS RE-ACCESSED WITH A DIFFERENT GUIDE CATHETER AND GUIDE WIRE; IT WAS NOTED THAT THE SAME GRAFTMASTER PRIOR TO USE AGAIN IN THE ANATOMY, HAD A DISLODGED STENT THAT WAS NOT ON THE BALLOON. THE STENT IMPLANT WAS NOT LOCATED IN THE CORONARY VESSEL NOR OUTSIDE THE ANATOMY. THE EXACT LOCATION WAS NOT DETERMINED. THE PROCEDURE WAS COMPLETED USING TWO 3.5 X 19 MM GRAFTMASTER STENTS AT 16 ATMOSPHERE, DUE TO THE LENGTH OF THE PERFORATION, WITH A SATISFACTORY RESULT. THE PATIENT WAS RELOCATED TO ICU IN STABLE CONDITION. NO ADDITIONAL INTERVENTION WAS COMPLETED RELATED TO THE PERFORATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569633 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3042441

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Required Intervention CONCOMITANT MEDICAL DEVICES