BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2103122 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03688
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    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. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS PARTIALLY DEPLOYED WITH BLOOD PRESENT AT THE MARKER LUMEN, INDICATING MARKING WAS ACHIEVED. THE DEVICE WAS RECEIVED WITH THE HANDLE IN THE UNLOCKED POSITION. THE SUTURE WAS LOOSE PROXIMAL OF THE DIMPLE CRIMP RING AND THE NEEDLES HAD BEEN BACKED DOWN INTO THE SHEATH. BASED ON THE REPORTED FAILURE TO DEPLOY THE NEEDLES, THE FACE OF THE BARREL WAS EXAMINED AND THREE NEEDLE STRIKE WITNESS MARKS WERE DETECTED. THE WITNESS MARK OF THE NEEDLES STRIKING THE BARREL INDICATES THE NEEDLES WERE DEFLECTED DURING DEPLOYMENT CAUSING THEM TO MISS THE NEEDLE SLOTS, STRIKING THE BARREL AND STOPPING DEPLOYMENT RESULTING IN THE REPORTED SURGICAL PROCEDURE. THESE FINDINGS ARE CONSISTENT WITH AND CONFIRM THE REPORT OF THE NEEDLE NOT BEING PRESENT AFTER DEPLOYMENT. A NEEDLE DEFLECTION CAN BE INFLUENCED BY BUT NOT LIMITED TO; MANUFACTURING, DEPLOYING DEVICE AT AN ANGLE GREATER THAN 45 DEGREES AND/OR DEPLOYMENT IN PATIENTS WITH CHALLENGING ANATOMICAL CONDITIONS SUCH AS A CALCIFIED OR SCARRED ACCESS SITE. THE LACK OF DEVICE STABILITY OR TORTUOUS PATHS CAN ALSO AFFECT NEEDLE DEPLOYMENT DURING USE. IT WAS ALSO REPORTED THAT THE ARTERIOTOMY WAS HEAVILY CALCIFIED, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR BASED ON THE GUIDANCE IN THE INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF THE PROSTAR XL DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. BASED ON THE INVESTIGATION FINDINGS, THE CAUSE FOR THE FAILURE OF THE NEEDLES TO DEPLOY DURING USE IS RELATED TO OPERATIONAL CONTEXT DURING USE OF THE PRODUCT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD FOR THIS LOT, DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS INCIDENT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE SECOND PROSTAR XL IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED TO PERFORM PRE-CLOSURE PLACEMENT OF THE SUTURES IN A HEAVILY CALCIFIED COMMON FEMORAL ARTERY PRIOR TO A CARDIAC VALVE POSITIONING PROCEDURE. REPORTEDLY, THE NEEDLES DID NOT PRESENT THEMSELVES. A SECOND PROSTAR XL WAS USED; HOWEVER, A SUTURE BREAK OCCURRED. THE PUNCTURE SITE WAS SUTURED CLOSED FOLLOWING THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 020216H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: PILOT 150SHEATH: 20 F