BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2983342 · Received February 28, 2013

    Report

    Report Number
    2024168-2013-01174
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. CONCOMITANT MEDICAL PRODUCTS: MARCUMAR- PAUSED SINCE (B)(6) 2013. THE SECOND PROSTAR XL DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4) - FAILURE TO FOLLOW STEPS. THE DEVICE WAS DEPLOYED USING AN 8 F SHEATH. PER THE INSTRUCTIONS FOR USE: THE PROSTAR XL 10 F PVS SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE AND REDUCING THE TIME TO HEMOSTASIS AND TIME TO AMBULATION OF PATIENTS WHO HAVE UNDERGONE CATHETERIZATION PROCEDURES USING 8.5 F TO 10 F SHEATHS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. HOWEVER, BASED ON THE INVESTIGATION THE PROBABLE CAUSE FOR THE WHITE SUTURE BEING REMOVED FROM THE ARTERY WITH THE DEVICE IS INCORRECT DEPLOYMENT TECHNIQUE. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT AN 8F INTRODUCER SHEATH WAS USED. THE PROSTAR INSTRUCTIONS FOR USE STATES: THE PROSTAR XL 10F PVS SYSTEM IS DESIGNED FOR USE IN CONJUNCTION WITH 8.5 TO 24F SHEATHS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED IN THE LEFT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. ONE SUTURE CAME OUT WITH THE DEVICE, THE OTHER SUTURE WAS LEFT IN THE ARTERY. A SECOND PROSTAR XL WAS DEPLOYED USING THE PRECLOSE TECHNIQUE AND BOTH SUTURES WERE SUCCESSFULLY DEPLOYED. THE ARTERIOTOMY WAS 8F AND THE VESSEL WAS NOT CALCIFIED. REPORTEDLY, AFTER THE AAA PROCEDURE, DURING THE ARTERIOTOMY CLOSURE, ALL THREE SUTURES WERE PULLED OUT OF THE PATIENT. HEMOSTASIS WAS ACHIEVED SURGICALLY BY APPLYING A VASCULAR PATCH. IT WAS REPORTED THAT THE PHYSICIAN IS IN-TRAINING IN THE USE OF THE PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87198 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21003K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8F, 14F, ASPIRIN, CLEXANE, HEPARIN