BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 4182747 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06800
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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 PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS UNKNOWN IF THE DEVICE IS RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE XIENCE XPEDITION REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    UPDATED CASE DETAILS: IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH TYPICAL CHEST PAIN AND SENT TO THE CATH LAB FOR TREATMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH LONG DISEASE. PRE-DILATATION WAS PERFORMED WITH RESIDUAL STENOSIS LESS THAN 40%. A XIENCE XPEDITION 2.25MM X 28MM WAS DEPLOYED DISTALLY AND A 2.5MM X 28MM IMPLANT WAS DEPLOYED PROXIMALLY WITH 1MM OVERLAPPING OF THE XIENCE XPEDITION. POST-DILATATION WAS DONE USING A TREK 3.0 X 20MM WHERE THE XIENCE XPEDITION SHOWED OVER EXPANSION AT BOTH EDGES. AN ARTERY RUPTURE TOOK PLACE IN TWO PLACES, FIRST AT THE OVERLAPPING AREA, AND THE SECOND RUPTURE AT THE DISTAL PART OF THE XIENCE XPEDITION. PRESSURE WENT DOWN DRAMATICALLY AND FLOW WAS OBSTRUCTED. A GRAFTMASTER WAS ADVANCED BUT FAILED TO CROSS THROUGH THE ABSORB WHICH CAUSED A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A NON-ABBOTT DRUG ELUTING STENT (3.00 X 20) WAS DEPLOYED TO COVER BOTH RUPTURE SITES. BLEEDING WAS STOPPED AND FLOW WAS RETAINED. THE PATIENT WAS STABILIZED AND ADMITTED TO THE HOSPITAL FOR 1 NIGHT IN THE CORONARY CARE UNIT FOR ANOTHER 24 HOURS OBSERVATION IN THE WARDS. THE PATIENT LEFT THE HOSPITAL ON (B)(6) 2014, TWO DAYS POST PROCEDURE, WHICH WAS CONSIDERED PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH TYPICAL CHEST PAIN AND SENT TO THE CATH LAB FOR TREATMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH LONG DISEASE. A XIENCE XPEDITION 2.25MM X 28MM WAS DEPLOYED DISTALLY AND A 2.5MM X 28MM IMPLANT WAS DEPLOYED PROXIMALLY WITH 1MM OVERLAPPING OF THE XIENCE XPEDITION. POST-DILATATION WAS DONE USING A TREK 3.0 X 20MM WHERE THE XIENCE XPEDITION SHOWED OVER EXPANSION AT BOTH EDGES. AN ARTERY RUPTURE TOOK PLACE IN TWO PLACES, FIRST AT THE OVERLAPPING AREA, AND THE SECOND RUPTURE AT THE DISTAL PART OF THE XIENCE XPEDITION. A GRAFTMASTER WAS ADVANCED BUT FAILED TO CROSS THROUGH THE 2.5X28 MM IMPLANT. A NON-ABBOTT DRUG ELUTING STENT (3.0 X 20 MM) WAS DEPLOYED TO COVER BOTH RUPTURE SITES. BLEEDING WAS STOPPED AND FLOW WAS RETAINED. THE PATIENT LEFT THE HOSPITAL TODAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660390 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention STENT: 2.25X28 MM XIENCE XPEDITION