BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2781529 · Received October 10, 2012

    Report

    Report Number
    2024168-2012-06410
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED FOR EVALUATION. VESSEL OCCLUSION RESULTING IN NO DISTAL PULSE IN THE LIMB IS A KNOWN POTENTIAL PATIENT EFFECT AS INDICATED IN THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). INTER DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. REPORTEDLY THE COMMON FEMORAL ARTERY WAS HEAVILY CALCIFIED. THE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE OTHER PERCLOSE PROGLIDE DEVICES, ARE BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ACHIEVED IN A HEAVILY CALCIFIED LEFT COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING DEPLOYMENT OF THE FIRST PROGLIDE DEVICE THROUGH A 8-FRENCH SIZED ACCESS SITE, ARTERIAL LUMINAL MARKING COULD NOT BE ACHIEVED THROUGH THE MARKER LUMEN. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND THE SUTURES OF TWO ADDITIONAL PROGLIDES WERE SEQUENTIALLY DEPLOYED 60 DEGREES OPPOSITE IN ORIENTATION AND SET TO THE SIDE. THE ACCESS SITE WAS NOT UPSIZED BECAUSE THE AAA REPAIR DEVICE WAS INSERTED THROUGH THE RIGHT COMMON FEMORAL ARTERY. AFTER CONCLUSION OF THE AAA REPAIR PROCEDURE, THE KNOTS FROM THE TWO PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS, BUT THERE WERE NO DISTAL PULSES PRESENT IN THE LIMB. A SURGICAL CUT DOWN WAS PERFORMED THAT REVEALED THAT THE PROGLIDE SUTURES ACHIEVED HEMOSTASIS, BUT THE VESSEL HAD A NARROW DIAMETER AND CALCIFIED PLAQUE OCCLUDED THE VESSEL. THE SUTURE WAS REMOVED, AN ENDARTERECTOMY WAS PERFORMED, AND THE VESSEL WAS SURGICALLY REPAIRED AND SUTURED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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-TEMECULA-CT 20802J1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SHEATH: 8-FRENCH, HEPARIN