BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 10165318 · Received June 17, 2020

    Report

    Report Number
    2024168-2020-05120
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 17, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176449
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED PATIENT EFFECT OF PERFORATION IS LISTED IN THE GRAFTMASTER RAPID EXCHANGE (RX) CORONARY STENT GRAFT SYSTEM, DOMESTIC INSTRUCTIONS FOR USE (IFU), AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE OTHER TWO GRAFTMASTER US RX STENTS REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT POSTERIOR DESCENDING ARTERY. MULTIPLE BALLOON INFLATIONS WERE MADE USING A 2.0 X 30 MM DILATATION CATHETER, STARTING AT NOMINAL PRESSURE AT THE DISTAL ANASTAMOSIS AND CONTINUING WITH MAXIMUM PRESSURE THROUGHOUT THE REMAINDER OF THE SVG. MULTIPLE AREAS OF PERFORATION WERE SEEN POST ANGIOPLASTY. THE 2.8 X 16 MM GRAFTMASTER STENT WAS IMPLANTED AT THE DISTAL ANASTAMOSIS. THE FIRST 4.0 X 16 MM GRAFTMASTER STENT WAS IMPLANTED, OVERLAPPING THE PROXIMAL EDGE OF THE 2.8 X 16 GRAFTMASTER. THE SECOND 4.0 X 16 MM GRAFTMASTER WAS THEN IMPLANTED, OVERLAPPING THE PROXIMAL EDGE OF THE FIRST 4.0 X 16 MM STENT. THE THREE GRAFTMASTER STENTS WERE OVERLAPPING IN THE DISTAL PORTION OF THE SVG. AFTER GRAFTMASTER IMPLANTATION, TWO NEW AREAS OF PERFORATION WERE SEEN. A 6.0 X 50 MM NON-ABBOTT COVERED STENT WAS IMPLANTED SO THAT IT OVERLAPPED THE EDGE OF THE SECOND 4.0 X 16 MM GRAFTMASTER STENT. A SECOND 6.0 X 50 MM NON-ABBOTT COVERED STENT WAS THEN IMPLANTED AT THE PROXIMAL SVG. THE PROXIMAL AND DISTAL PORTION OF THE SVG WERE COMPLETELY SEALED WITH THE GRAFTMASTER AND NON-ABBOTT STENTS; HOWEVER, LEAKING WAS NOTED AT A SHORT MID PORTION THAT REMAINED UNCOVERED. A THIRD 6.0 X 50 MM NON-ABBOTT COVERED STENT WAS IMPLANTED AT THE MID PORTION, SO THAT IT OVERLAPPED THE TWO NON-ABBOTT STENTS. THE ENTIRE LENGTH OF THE SVG WAS NOW COVERED AND NO EXTRAVASATION WAS SEEN. DURING THE PROCEDURE, THE PATIENT REQUIRED PERICARDIOCENTESIS; HOWEVER, THE STUDY PHYSICIAN INDICATED THAT THIS COMPLICATION WAS UNRELATED TO THE DEVICE. THE PATIENT WAS INTUBATED DURING THE PROCEDURE AND SENT TO THE INTENSIVE CARE UNIT POST PROCEDURE. THE PATIENT REMAINS HOSPITALIZED, BUT HAS BEEN EXTUBATED AND IS IMPROVING. PER PHYSICIAN, THE CAUSE OF THE MULTIPLE PERFORATIONS WAS THE FRIABILITY OF THE SVG. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627363 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012582-16 8120541 08717648176449

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention