BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACIFIC XTREME

    MDR report key: 2875234 · Received December 17, 2012

    Report

    Report Number
    3004066202-2012-00151
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    May 1, 2013
    Report Date
    February 3, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K103464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DISSECTION. CONCLUSIONS: DISSECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION: (RESTENOSIS REQUIRING MEDICAL/ SURGICAL INTERVENTION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN USED ONE PACIFIC XTREME PTA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE SFA OF THE LEFT LEG. DEVICE WAS SUCCESSFUL; HOWEVER, IT WAS REPORTED THAT A DISSECTION (TYPE B) OCCURRED DURING THE PROCEDURE. NO INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    TVR OCCURRED 8 MONTHS POST INDEX PROCEDURE AND NOT 5 MONTHS AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    THE INVESTIGATOR ASSESSED THAT THE DISSECTION EVENT WHICH OCCURRED DURING THE INDEX PROCEDURE WAS DEFINITELY RELATED TO THE STUDY DEVICE AND THE STUDY PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE THE PATIENT UNDERWENT A TVR TO TREAT STENOSIS OF THE LEFT SFA VESSEL. PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R ASPIRIN AND CLOPIDOGREL