BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1474714 · Received September 16, 2009

    Report

    Report Number
    2953144-2009-01243
    Event Type
    Injury
    Date Received
    September 16, 2009
    Date of Event
    August 25, 2009
    Report Date
    August 25, 2009
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. DEVICE #1 PROSTAR XL, PART# 12322-02, LOT#77045-6H, IS BEING FILED UNDER MEDWATCH MANUFACTURER REPORT NUMBER: 2953144-2009-01241. DEVICE #2 PROSTAR XL, PART# 12322-02, LOT#77045-6H, IS BEING FILED UNDER MEDWATCH MANUFACTURER REPORT NUMBER: 2953144-2009-01242. IMPROPER METHOD, (PATIENT SELECTION): THE INSTRUCTIONS FOR USE (IFU) FOR THE PROSTAR XL DEVICE STATES, "SPECIAL PATIENT POPULATIONS, THE SAFETY AND EFFECTIVENESS OF THE PROSTAR XL PVS SYSTEM HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE."

    Description of Event or Problem · 1

    DEVICE #3 MALFUNCTION: FAILURE TO DEPLOY-NEEDLES. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS, SURGICALLY PATCHED. IT WAS REPORTED THAT A PHYSICIAN UNKNOWN IF TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING NEEDLE DEPLOYMENT, THE NEEDLES WERE DEFLECTED BY THE SKIN AND COULD NOT PENETRATE THE VESSEL WALL. USE OF A SECOND AND THIRD PROSTAR XL WERE ATTEMPTED WITH THE SAME RESULTS. THE ARTERY WAS SURGICALLY PATCHED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR - REDWOOD CITY NA 77045-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention DEVICE #1 PROSTAR XL| GRAFTMASTER 3.5MM X 19MM| DEVICE #2 PROSTAR XL| 18FR PROCEDURAL SHEATH