BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 5144173 · Received October 12, 2015

    Report

    Report Number
    3004066202-2015-00446
    Event Type
    Injury
    Date Received
    October 12, 2015
    Date of Event
    July 8, 2015
    Report Date
    February 5, 2016
    Manufacturer
    INVATEC TECHNOLOGY CENTER GMBH
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CEC HAS ADJUDICATED THE REPORTED STENOSIS OF THE LSFA WAS RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE OR DRUG. OUTCOME WAS RESOLVED FOR STENOSIS OF LEFT SFA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PREVIOUS MDR SUBMITTED WITH AWARE DATE (B)(6) 2015 IN ERROR, CORRECT AWARE DATE IS (B)(6) 2015.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PHYSICIAN USED ONE IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE SFA OF THE LEFT LEG. DEVICE WAS SUCCESSFUL. APPROXIMATELY 23.5 MONTHS POST INDEX PROCEDURE THE PATIENT HAD STENOSIS (99%) OF THE TARGET LESION IN THE LEFT SFA WHICH WAS TREATED APPROXIMATELY 2.5 MONTHS LATER WITH ONE INPACT ADMIRAL DEB AND ONE NON-MDT STENT. THE INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, PROCEDURE AND DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675133 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU INVATEC TECHNOLOGY CENTER GMBH 2D021218

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention