BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 11704120 · Received April 21, 2021

    Report

    Report Number
    2024168-2021-03387
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 21, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648152139
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT 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. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF PERFORATION IS LISTED IN THE CORONARY DILATATION CATHETERS (CDC), NC TREK RX, INSTRUCTION FOR USE AS A KNOWN PATIENT EFFECT. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE ADDITIONAL TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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 TWO GRAFTMASTER DEVICES REFERENCED 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
    600380 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012455-08 00122G1 08717648152139

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention