BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 11704104 · Received April 21, 2021

    Report

    Report Number
    2024168-2021-03386
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 21, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176395
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL THE PERFORATION; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IN THIS CASE, IT IS POSSIBLE THAT THE CHOSEN STENT DIAMETER WAS UNDERSIZED FOR THE LESION, THUS CAUSING THE REPORTED FAILURE TO SEAL; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ADDITIONAL GRAFTMASTER DEVICE AND THE NC TREK ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH MULTIPLE CORONARY ARTERY LESIONS AND TWO CORONARY ARTERY GRAFTS, A LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT TO THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, AND A SAPHENOUS VEIN GRAFT (SVG) TO THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY. NON-ABBOTT STENTS (A SYNERGY AND A RESOLUTE ONYX) WERE IMPLANTED. USING A TREK BALLOON CATHETER, POST-DILATATION WAS PERFORMED ON THE SYNERGY 4.5 STENT DUE TO STENT UNDEREXPANSION. DURING DILATATION WITH A 5.0X8MM NC TREK BALLOON CATHETER, AN SVG TO RIGHT CORONARY ARTERY (RCA) AND PROXIMAL CX PERFORATION WAS OBSERVED. THE PERFORATION WAS WITHOUT CLINICAL EVIDENCE OF TAMPONADE. AS TREATMENT, TWO 3.5X16MM GRAFTMASTER STENTS (1012581-16, 0012241) WERE IMPLANTED, PARTIALLY SEALING THE PERFORATION. REPORTEDLY, THE SELECTED STENT DIAMETERS WERE UNDERSIZED FOR THE VESSEL AND A MINIMAL PERSISTENT LEAK WAS NOTED. ANGIOMAX WAS DISCONTINUED. MULTIPLE BALLOON DILATATIONS WERE PERFORMED TO THE GRAFTMASTERS AND A NON-ABBOTT (SYNERGY) STENT WAS IMPLANTED WHICH TERMINATED THE LEAK. PER PHYSICIAN, THE GRAFTMASTER DEVICES DID NOT CAUSE OR CONTRIBUTE TO COMPLICATION OR ADVERSE EVENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO SUBSEQUENT ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596136 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012581-16 0012241 08717648176395

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention