BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 17279320 · Received July 7, 2023

    Report

    Report Number
    9612164-2023-03044
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 7, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRP35DR-06-200-120 STENT, LOT NO: B401469, (IMPLANT DATE : (B)(6) 2023). EVX35-06-060-120 STENT, LOT NO: B477342, (IMPLANT DATE: (B)(6) 2023). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DURING THE INDEX PROCEDURE A PROTÉGÉ EVERFLEX STENT, AN EVERFLEX ENTRUST STENT AND AN IN.PACT ADMIRAL BALLOON CATHETER (SBI05025013P) WERE USED TO TREAT THE PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND THE POPLITEAL 1 SEGMENT OF THE LEFT LEG. A MEDTRONIC DRUG COATED BALLOON WAS ALSO USED FOR PRE-DILATION. DURING THE PROCEDURE A DISSECTION OCCURRED DURING PRE-DILATION WHICH WAS CONFIRMED TO HAVE BEEN CAUSED BY THE MEDTRONIC DRUG COATED PRE-DILATION BALLOON. IT WAS STATED THAT THE PROTEGE EVERFLEX STENT, EVERFLEX ENTRUST STENT AND IN.PACT ADMIRAL BALLOON CATHETER (SBI05025013P) DID NOT HAVE ANY ISSUES AND DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055320 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other SBI05025013P DCB,