BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2060262 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02671
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4): FAILURE TO FOLLOW STEPS/INSTRUCTIONS (SHEATH USED GREATER THAN 10FR). THE ARTICLE INDICATES THE PROCEDURES WERE PERFORMED FROM (B)(6) 2008 TO (B)(6) 2010. CONCOMITANT MEDICAL PRODUCTS: MICS PROCEDURES, MEDICAL DEVICES USED: TWO-STAGE CANNULA (RAP FVTM; ESTECH INC), ARTERIAL CANNULA (MEDTRONIC DLP 17 OR 19 FR); CENTRIFUGAL PUMP (MEDTRONIC BIOMEDICUS, (B)(4)), PERCUTANEOUS JUGULAR CANNULA, COREVALVE SYSTEM (MEDTRONIC, INC). TAVI PROCEDURE, MEDICAL DEVICES USED: PIGTAIL CATHETER, 18F SHEATH, STIFF GUIDEWIRE. THE PROSTAR XL DEVICES WERE NOT SAVED AT THE FACILITY FOR RETURN AND EVALUATION. A ROOT CAUSE FOR THE REPORTED EXPERIENCES COULD NOT BE CONCLUDED; WITHOUT THE PRODUCT TO EXAMINE A CAUSE RELATED TO A MANUFACTURING ISSUE CAN NOT BE DETERMINED. THE LOT NUMBERS WERE NOT IDENTIFIED; THEREFORE, LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. PERCUTANEOUS FEMORAL ARTERY ACCESS WITH PROSTAR DEVICE FOR INNOVATIVE MITRAL AND AORTIC INTERVENTIONS. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 39 (2011) 600-602. BY JEAN-FRANCOIS OBADIA, ET AL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED DURING LITERATURE REVIEW THAT ASSESSED THE FEASIBILITY, SAFETY AND EFFICACY OF LARGE PERCUTANEOUS FEMORAL ARTERY ACCESS USING THE PROSTAR CLOSURE DEVICE FOR INNOVATIVE MITRAL (MICS) AND AORTIC INTERVENTIONS (TAVI): PERCUTANEOUS FEMORAL ARTERY ACCESS WAS PERFORMED IN 156 PATIENTS (40 PATIENTS TAVI, 116 PATIENTS MICS). OF THE 116 MICS PATIENTS: 92 WERE FOR REPAIR, 15 REPLACEMENT, 6 ASD AND 3 MYXOMA SURGERY. COMPLICATIONS OBSERVED IN THE TAVI GROUP INCLUDED: 4 SUPERFICIAL BLEEDINGS THAT REQUIRED SURGICAL ACCESS AND 1 MASSIVE SUPERFICIAL BLEEDING WHERE THE PHYSICIAN ATTEMPTED TO OPEN DIRECTLY THE GROIN SURGICALLY WITHOUT ANY CONTROL OF THE BLEEDING BY AN ENDO-BALLOON. ADDITIONALLY, 1 RETROPERITONEAL BLEEDING (RPB) DUE TO A TRANS-FIXIANT AND TOO HIGH PUNCTION OF THE FEMORAL ARTERY LEADING TO AN EFFUSION IN THE RETRO-PERITONEAL SPACE. IF CLOSURE FAILED IN THE TAVI PROCEDURES, AN 18FR SHEATH WAS INSERTED FOR TEMPORARY HEMOSTASIS AND SURGICAL EXPOSURE WAS PERFORMED UNDER STABLE CONDITIONS. COMPLICATIONS OBSERVED IN THE MICS GROUP INCLUDED: 3 SUPERFICIAL BLEEDINGS WERE EASILY MANAGED BY DIRECT SURGICAL ACCESS; 2 RPB AND 1 ARTERIOVENOUS FISTULA (AVF) THAT REQUIRED DEEP SURGICAL ACCESS OR COMPLEX VASCULAR SURGERY. THE PROSTAR DEVICE COULD BE IMPLANTED IN ALL BUT 2 PATIENTS. IN MICS PROCEDURES, VEIN AND ARTERIAL ACCESS WERE CLOSED BY SKIN PURSE-STRING STITCH AND PROSTAR DUAL STITCH, RESPECTIVELY. A 24 H COMPRESSION WAS APPLIED. ALL TOTAL SEVERE COMPLICATIONS OCCURRED DURING THE INITIAL EXPERIENCE, FIRST 50 PATIENTS, VERSUS 0 AMONG 106 FOLLOWING PATIENTS. SUBSEQUENT COMPLICATIONS WERE NOT SEVERE AND EASILY MANAGED WITH SIMPLE SURGICAL EXPOSURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R