BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 3181229 · Received June 21, 2013

    Report

    Report Number
    3004066202-2013-00099
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    November 15, 2011
    Report Date
    May 23, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (RETENOSIS). (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS TREATED WITH AN INPACT AMPHIRION PACLITAXEL-ELUTING PTA BALLOON CATHETER IN THE PERONEAL ARTERY DUE TO DETERIORATION OF RUTHERFORD CLASS. HOWEVER A RUPTURE OF THE PERONEAL WAS REPORTED TO HAVE OCCURRED AND 4 STENT GRAFTS WERE IMPLANTED AS TREATMENT. INVESTIGATOR ASSESSED THAT THE RUPTURE OF THE PERONEAL WAS NOT RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. LYSIS AND AN AMPHIRION DEEP PTA BALLOON CATHETER WERE USED TO TREAT OCCLUSION OF THE RIGHT PERONEAL ARTERY ON THE SAME DAY. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. RESTENOSIS OF THE RIGHT PERONEAL OCCURRED APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE AND A PTA PROCEDURE WAS CARRIED OUT. INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY TO BE RELATED TO THE STUDY DEVICE. OCCLUSION OF THE RIGHT FEM-POP BYPASS AND THE BYPASS ANASTOMOSIS OCCURRED APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE. A PACIFIC XTREME PTA BALLOON CATHETER WAS USED TO TREAT THE SFA. LYSIS AND ROTAREX WERE ALSO CARRIED OUT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. STENOSIS OF THE RIGHT SFA OCCURRED APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE AND A PTA PROCEDURE WAS CARRIED OUT. AN AMPHIRION DEEP PTA BALLOON CATHETER AND TWO PACIFIC XTREME PTA BALLOON CATHETERS WERE USED AS TREATMENT. OCCLUSION OF THE FEM-POP BYPASS OCCURRED APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE WHICH WAS TREATED WITH ROTAREX AND PTA PROCEDURE. A PACIFIC XTREME PTA BALLOON CATHETER AND TWO ADMIRAL XTREME PTA BALLOON CATHETERS WERE USED TO TREAT THE RIGHT SFA. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. OCCLUSION OF THE RIGHT PERONEAL OCCURRED APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE AND A PTA WAS CARRIED OUT. A PACIFIC XTREME PTA BALLOON CATHETER WAS USED AS TREATMENT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. OCCLUSION OF THE RIGHT ATA OCCURRED APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE AND A PTA WAS CARRIED OUT. AN AMPHIRION DEEP PTA BALLOON CATHETER AND A NON-MEDTRONIC STENT WERE USED AS TREATMENT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. THROMBUS OF THE TTF OCCURRED APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE AND PTA AND STENTING WAS CARRIED OUT. AN ADMIRAL XTREME PTA BALLOON CATHETER WAS USED TO TREAT THE RIGHT PERONEAL. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT R ELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. RESTENOSIS OF THE RIGHT TTF OCCURRED APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE AND A PTA WAS CARRIED OUT. AN IN.PACT AMPHIRION PACLITAXEL-ELUTING PTA BALLOON CATHETER WAS USED TO TREAT THE RIGHT PERONEAL. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. RESTENOSIS OF THE RIGHT ATA OCCURRED APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE AND A PTA WAS CARRIED OUT. AN IN.PACT AMPHIRION PACLITAXEL-ELUTING PTA BALLOON CATHETER WAS USED AS TREATMENT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281974 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R CLOPIDOGREL AND ASPIRIN.