BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3800742 · Received May 8, 2014

    Report

    Report Number
    2024168-2014-02938
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ABOVE RATED BURST PRESSURE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A CINE OF THE PROCEDURE WAS REVIEWED BY ABBOTT VASCULAR CLINICAL AND CONCLUDED THAT THE IMAGES WERE CONSISTENT WITH THE REPORTED EVENT. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS REPORTED THAT THE FINAL INFLATION OF THE GRAFTMASTER DEVICE WAS TO 18 ATMOSPHERES (ATM). IT SHOULD BE NOTED THAT THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE (IFU) STATES: DO NOT EXCEED RATED BURST PRESSURE (RBP) AS INDICATED ON PRODUCT LABEL. USE OF PRESSURES HIGHER THAN SPECIFIED ON THE PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. IN THIS CASE, IT IS UNLIKELY THE IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE CATHETER: JL 4 6F; JR4 6F; STENT: BIOMATRIX 3.5 X 28 MM. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATATION WITH A 2.5 X 15 MM NON-ABBOTT BALLOON, A NON-ABBOTT 3.5 X 28 MM DRUG-ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A PERFORATION WAS NOTED AT THE PROXIMAL LAD. AN RX GRAFTMASTER 3.5 X 19 MM STENT WAS ADVANCED TO TREAT THE PERFORATION. THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS INFLATED AT 10 TO 12 ATMOSPHERES (ATM) FOR 20 SECONDS. HOWEVER, IT WAS NOTED THAT THE GRAFTMASTER STENT WAS NOT WELL EXPANDED AFTER 15 MINUTES. THE SDS BALLOON WAS DEFLATED AND PULLED BACK AND THEN RE-INFLATED AT 10 TO 12 ATM FOR 50 SECONDS, FOLLOWED BY A THIRD INFLATION AT 14 TO 16 ATM FOR 30 SECONDS. THE FINAL INFLATION WAS PERFORMED AT 18 ATM. TOTAL INFLATION TIME WAS 1 MINUTES 37 SECONDS. OVERALL, THE FINAL RESULT WAS REPORTED TO BE OKAY. NO ADVERSE PATIENT SEQUELA WAS REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279225 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 211094N

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention CONCOMITANT MEDICAL DEVICES