BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACIFIC PLUS

    MDR report key: 4234154 · Received November 7, 2014

    Report

    Report Number
    3004066202-2014-00187
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    October 7, 2014
    Report Date
    May 15, 2015
    Manufacturer
    INVATEC TECHNOLOGY CENTER GMBH
    Product Code
    LIT
    PMA / PMN Number
    K123358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSIONS: OCCLUSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE PREVIOUSLY REPORTED REVASCULARIZATION APPROXIMATELY 19.5 MONTHS POST INDEX PROCEDURE THERE WAS NO PTA PERFORMED USING A PACIFIC PLUS BALLOON. PACIFIC PLUS BALLOON WAS USED ONE DAY LATER TO TREAT OCCLUSION OF THE SFA AND APOP INSTENT RIGHT. PATIENT ALSO UNDERWENT ROTAREX, THROMBECTOMY AND LYSIS TO TREAT THIS EVENT.

    Description of Event or Problem · 1

    THE CEC ADJUDICATED THAT THE PREVIOUSLY REPORTED STENOSIS AND THROMBUS OF THE RIGHT SFA AND RESTENOSIS OF THE RIGHT POPLITEAL REPORTED APPROXIMATELY 20 MONTHS POST INDEX WAS RELATED TO THE STUDY DEVICE BUT NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 1

    DURING THE REVASCULARIZATION TO TREAT THE RIGHT INSTENT OCCLUSION OF THE SFA AND APOP APPROXIMATELY 19.5 MONTHS POST INDEX PROCEDURE ONE PACIFIC PLUS PTA BALLOON CATHETER WAS USED. OUTCOME OF THE EVENT IS RESOLVED. THE FOLLOWING DAY DURING THE REVASCULARIZATION TO TREAT THE STENOSIS AND RESIDUAL THROMBOS OF THE SFA RIGHT AND INSTENT RE-STENOSIS OF THE APOP RIGHT, THE PTA AND DEB TREATMENT INCLUDED A PACIFIC PLUS PTA BALLOON CATHETER, NON-MEDTRONIC BALLOON, AMPHIPRION DEEP PTA BALLOON CATHETER, 2 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERS AND 2 IN.PACT PACIFIC PACLITAXEL-ELUTING PTA BALLOON CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719693 PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC TECHNOLOGY CENTER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention