BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3250848 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04719
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: V14 CONTROL; GUIDE CATH: 5 FR GLIDE; SHEATH: RDC GUIDE SHEATH. (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT OCCLUSION AND SPASM ARE LISTED IN THE OTW GRAFTMASTER INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF JOSTENT CORONARY STENT GRAFT PROCEDURES. IT SHOULD BE NOTED THAT THE IFU STATES IN THE INDICATIONS SECTION THAT THE JOSTENT GRAFTMASTER IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS GREATER THAN OR EQUAL TO 2.75MM IN DIAMETER. THE EFFECTIVENESS OF THIS DEVICE FOR THIS USE HAS NOT BEEN DEMONSTRATED. LONG-TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. IN THIS CASE, IT IS UNKNOWN IF THE USE OF THE GRAFTMASTER DEVICE OUTSIDE OF THE CORONARY ANATOMY CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE HEPATIC ARTERY THE GUIDE SHEATH AND A NON-ABBOTT GUIDE WIRE WERE USED TO DEPLOY A 3.5 X 19 MM GRAFTMASTER STENT ACROSS THE COMMON/PROPER HEPATIC ARTERY AT THE LEVEL OF THE PSEUDOANEURYSM NECK. POST STENT ANGIOGRAPHY DEMONSTRATED A TYPE 1A ENDOLEAK INTO THE PSEUDOANEURYSM SAC. A 5 X 20 MM NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO ANGIOPLASTY THE STENT AND NO FURTHER LEAK WAS DEMONSTRATED ON POST ANGIOPLASTY ANGIOGRAM. NOTABLY WAS A FOCAL NARROWING PRESENT IMMEDIATELY ADJACENT TO THE PROXIMAL END OF THE STENT, WITHOUT HEMODYNAMICALLY SIGNIFICANT STENOSIS POSSIBLY REPRESENTING SPASM. FLOW IS MAINTAINED THROUGH THE STENT AND INTO THE RIGHT HEPATIC ARTERY BRANCHES. REPEAT ANGIOGRAPHY WAS PERFORMED THROUGH THE NON-ABBOTT SHEATH WITHIN THE COMMON HEPATIC ARTERY. A NON-ABBOTT CLOSURE DEVICE WAS PLACED AT THE ACCESS SITE. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WAS NO IMMEDIATE COMPLICATION OR BLOOD LOSS. 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
    352702 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention