BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904655 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02862
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLUNGER WITH THE ANTERIOR NEEDLE TIP, LINK AND CUFFS WERE NOT RETURNED. EVALUATION OF THE RETURNED SHEATH, GUIDE, FOOT AND LEVER WERE FOUND TO BE NORMAL AND UNDAMAGED. THE SUTURE WAS RETURNED LOADED IN THE DEVICE WITH THE KNOT UNRAVELED AND THE POSTERIOR NEEDLE TIP LOOSE. THE POSTERIOR AND ANTERIOR FOOT WAS EXAMINED FOR NEEDLE STRIKE MARKS AND NONE WERE DETECTED INDICATING THE NEEDLE WAS DEFLECTED OUTSIDE OF THE FOOT POCKET. THE SUTURE WAS PULLED FROM THE DEVICE WITH NO SIGNIFICANT RESISTANCE DETECTED INDICATING THE SUTURE DRAG WAS NOT A CONTRIBUTING FACTOR IN THIS EVENT. A PROXY PLUNGER WAS INSERTED AND THE NEEDLE TRAJECTORY WAS ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, A POSTERIOR MISS OCCURRED AS EVIDENCED BY THE SUTURE WITH POSTERIOR NEEDLE TIP BEING RETURNED LOADED IN THE DEVICE. THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS IS DUE TO NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT POSSIBLY CAUSED BY INTERACTION WITH ANATOMY OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED HIGHER THAN INTENDED AND UNINTENTIONALLY COVERED THE LEFT RENAL. A CONTRALATERAL LEG COMPONENT WAS THEN IMPLANTED. THE CONTRALATERAL LEG COMPONENT PUSHED THE TRUNK-IPSILATERAL LEG COMPONENT UP, AND COVERED BOTH RENAL ARTERIES. THE PHYSICIAN WE ABLE TO PULL THE TRUNK-IPSILATERAL LEG COMPONENT BACK DOWN. FINAL ANGIOGRAM SHOWED THAT ONLY THE LEFT RENAL WAS PARTIALLY COVERED. THE PT TOLERATED THE PROCEDURE AND NO FURTHER PROBLEMS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 930076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention