BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2240326 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06226
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED TO FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. THE PRODUCT EXPERIENCE MAY BE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO A MANUFACTURING DEFICIENCY, PATIENT ANATOMICAL CONDITIONS, AND OPERATOR DEPLOYMENT TECHNIQUE. SUTURE PULLING OUT OF THE ARTERY CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO A MANUFACTURING DEFICIENCY, PATIENT ANATOMICAL CONDITIONS, OR OPERATOR DEPLOYMENT TECHNIQUE. A PATIENT ANATOMICAL CONDITION, SUCH AS FRAIL TISSUE, MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. ADDITIONALLY, THE PATIENT HAS A HISTORY OF PRIOR ARTERIOTOMY CLOSURE IN THE LEFT AND RIGHT COMMON FEMORAL ARTERIES. NO OTHER RELEVANT INFORMATION REGARDING PATIENT ANATOMICAL CONDITION WAS PROVIDED. IT WAS REPORTED THAT THE OPERATOR APPLIED EXCESSIVE FORCE BY PULLING THE SUTURE TOO HARD, WHICH IS LIKELY THE CAUSE FOR THE REPORTED SUTURE BEING PULLED OUT OF THE ARTERY. A CONCLUSIVE CAUSE FOR THE REPORTED PRODUCT EXPERIENCE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT THE OPERATOR PULLED THE SUTURE TOO HARD CAUSING IT TO PULL OUT OF THE ARTERY. IN ADDITION, DEVIATING FROM THE INSTRUCTIONS FOR USE (IFU) IS THE LIKELY CAUSE FOR THE REPORTED NEEDLES NOT FULLY CAPTURING ARTERIAL TISSUE THAT WAS DUE TO AN INCREASE IN THE SIZE OF THE ACCESS SITE CAUSED FROM THE DEVICE BEING ADVANCED TOO FAR INTO THE ARTERY. A CONCLUSIVE CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED; HOWEVER, DEVIATING FROM THE IFU MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THE REPORTED LOT. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT DID NOT REVEAL ANY OTHER INCIDENTS RELATED TO NEEDLE DEPLOYMENT. DURING MANUFACTURING, DEVICES ARE VISUALLY INSPECTED AND A SAMPLING OF THE DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. NO PRODUCT QUALITY DEFICIENCY WAS NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE #1 PROSTAR XL IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. (B)(4), FAILURE TO FOLLOW INSTRUCTIONS. IT REPORTED THAT THE BARREL OF PROSTAR XL DEVICE WAS ADVANCED TOO FAR INTO THE VESSEL, WHICH CAUSED AN INCREASE IN THE SIZE OF THE ACCESS SITE THAT AFFECTED THE ABILITY OF THE NEEDLES TO FULLY CAPTURE ARTERIAL TISSUE. THE INSTRUCTIONS FOR USE STATE UNDER PROSTAR XL PVS DEVICE PLACEMENT TO CAREFULLY BACK-LOAD THE PROSTAR XL DEVICE OVER THE GUIDE WIRE UNTIL THE GUIDE WIRE EXIT PORT IS JUST ABOVE THE SKIN LINE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ABDOMINAL AORTIC ENDOPROSTHESIS PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN MODERATELY SCARRED RIGHT AND LEFT COMMON FEMORAL ARTERIES (LCFA) AND (RCFA) USING PROSTAR XL DEVICES. REPORTEDLY, AFTER DEPLOYING THE SUTURE IN THE LCFA FROM PROSTAR XL DEVICE #1, AN ATTEMPT WAS MADE TO DEPLOY THE SUTURE IN THE RCFA WITH A SECOND PROSTAR XL DEVICE. HOWEVER, THE BARREL OF SECOND PROSTAR XL DEVICE WAS ADVANCED TOO FAR INTO THE RCFA, WHICH CAUSED AN INCREASE IN THE SIZE OF THE ACCESS SITE THAT AFFECTED THE ABILITY OF THE NEEDLES TO FULLY CAPTURE ARTERIAL TISSUE. AFTER COMPLETION OF THE ABDOMINAL AORTIC ENDOPROSTHESIS PROCEDURE, AS THE KNOT OF PROSTAR XL DEVICE #1 WAS ADVANCED FORWARD TO THE LCFA ARTERIOTOMY, THE SUTURE WAS PULLED TOO HARD CAUSING THE SUTURE TO PULL OUT FROM THE VESSEL. BOTH THE LCFA AND RCFA WERE SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR XL DEVICE. 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 040116H

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention PROCEDURAL SHEATHS 18F AND 6F.