BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 10643343 · Received October 7, 2020

    Report

    Report Number
    2024168-2020-08340
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 11, 2020
    Report Date
    November 4, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176401
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 DETERMINED THE REPORTED FAILURE TO ADVANCE AND SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER DEVICES MENTIONED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY STENTING PROCEDURE, A 3.0 X 15 MM XIENCE SIERRA DRUG-ELUTING STENT WAS DEPLOYED ACROSS THE DISTAL STENOSIS AT 16 ATMOSPHERES. AT THAT TIME, THERE WAS A DISRUPTION OF THE PROXIMAL TO MID RIGHT CORONARY ARTERY STENOSIS AND THE DECISION WAS MADE TO COVER THIS AREA WITH A DRUG-ELUTING STENT. A 3.5 X 28 MM XIENCE SIERRA WAS THEN SUCCESSFULLY IMPLANTED AND POST-DILATED WITH A 3.5X20MM NC TREK. AFTER POST-DILATATION, A PERFORATION WAS NOTED. AT THAT TIME, A 3.5 X16 MM GRAFTMASTER COVERED STENT (9072241) WAS IMPLANTED ACROSS THE PERFORATION AT 20 ATMOSPHERES (ABOVE RATED BURSE PRESSURE), RESOLVING THE PERFORATION; HOWEVER, THE STENT WAS POST-DILATED WITH THE 3.5X20MM NC TREK AND THE PERFORATION WAS NOTED TO CONTINUE TO LEAK. TWO ADDITIONAL 3.5X19 GRAFTMASTER STENTS (9112841, 9032941) WERE IMPLANTED, ONE PROXIMAL AND ONE DISTAL TO THE IMPLANTED 3.5X16MM GRAFTMASTER STENT, BUT THE PERFORATION CONTINUED TO LEAK. AN ADDITIONAL XIENCE SIERRA 3.5 X 38 MM STENT WAS IMPLANTED BUT THE PERFORATION CONTINUED TO LEAK. A 2.8X19MM GRAFTMASTER STENT (8120641) WAS ADVANCED, BUT FAILED TO GET DISTAL TO THE LAST GRAFTMASTER STENT AND THE XIENCE SIERRA. ANOTHER 2.8X19MM GRAFTMASTER STENT (9092641) KINKED UPON INSERTION INTO THE PATIENT. A 3.5X19 GRAFTMASTER STENT (9060541) WAS ADVANCED, BUT FAILED TO CROSS THE IMPLANTED XIENCE SIERRA STENT. ANOTHER 2.8X19MM GRAFTMASTER STENT (8120641) WAS ADVANCED BUT FAILED TO GET DISTAL TO THE LAST GRAFTMASTER STENT AND THE XIENCE SIERRA. THE PATIENT WAS TAKEN TO SURGERY WHERE THE PERFORATION WAS TREATED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107279 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012581-19 9060541 08717648176401

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention GRAFTMASTER 3.5 X 16 MM| GRAFTMASTER 3.5 X 19 MM| GRAFTMASTER 3.5 X 19 MM| XIENCE 3.5 X 38 MM| XIENCE SIERRA 3.0 X 15 MM| XIENCE SIERRA 3.5 X 28 MM| GRAFTMASTER 3.5 X 16 MM| GRAFTMASTER 3.5 X 19 MM| GRAFTMASTER 3.5 X 19 MM| XIENCE 3.5 X 38 MM| XIENCE SIERRA 3.0 X 15 MM| XIENCE SIERRA 3.5 X 28 MM