BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2210844 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05714
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE COMPLAINT. CONTINUED BLEEDING AFTER SUTURE DEPLOYMENT MAY BE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE, OR PATIENT ANATOMICAL CONDITIONS. PATIENT ANATOMY MAY CONTRIBUTE TO THE REPORTED CONTINUED BLEEDING AFTER SUTURE DEPLOYMENT. FEMORAL ANGIOGRAMS REVEALED NO PRESENCE OF VESSEL CALCIFICATION OR LESIONS, BUT THE ARTERIES WERE TORTUOUS. THE PATIENT ALSO HAS A HISTORY OF PRIOR ARTERIOTOMY OF THE RIGHT COMMON FEMORAL ARTERY AND TARGET GROIN. IT WAS BELIEVED THAT THE HOLE OF THE ARTERY WAS TOO BIG FOR THE PROSTAR XL DEVICE. PATIENT ANATOMICAL CONDITIONS AND THE SIZE OF THE ARTERIAL HOLE MAY HAVE CONTRIBUTED TO THE REPORTED CONTINUED BLEEDING AFTER SUTURE DEPLOYMENT THAT REQUIRED SURGICAL SUTURES TO ACHIEVE HEMOSTASIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE WAS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED, TO INCLUDE SUTURE PLACEMENT, TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE SECOND PROSTAR XL IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ABDOMINAL AORTIC ENDOPROSTHESIS PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS SUCCESSFUL IN THE LEFT AND RIGHT COMMON FEMORAL ARTERIES (LCFA) (RCFA) USING PROSTAR XL DEVICES. REPORTEDLY, AFTER SUTURE DEPLOYMENT IN A 20F SHEATH SIZE RCFA PUNCTURE SITE, THE KNOT WAS ADVANCED TO THE ARTERY SURFACE, BUT A BIT OF BLEEDING CONTINUED THAT REQUIRED A COUPLE OF ADDITIONAL SURGICAL SUTURES NEXT TO THE PROSTAR XL SUTURES. IT WAS BELIEVED THAT THE HOLE OF THE ARTERY WAS TOO BIG FOR THE PROSTAR XL DEVICE. REPORTEDLY, DURING PROSTAR XL DEVICE DEPLOYMENT IN THE LCFA THROUGH A 14F SHEATH SIZE PUNCTURE, PROPER ARTERIAL LUMINAL MARKING WAS NOT ACHIEVED FROM THE DEVICE MARKER LUMEN. DURING NEEDLES DEPLOYMENT, WHEN FORCE WAS APPLIED TO PULL THE NEEDLES AT THE BARREL, THE SUTURES DID NOT CLOSE THE ARTERY BECAUSE THEY WERE DEPLOYED IN SUBCUTANEOUS TISSUE INSTEAD OF THE ARTERY. THE SITE WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. IT WAS BELIEVED THAT THE INCIDENT OCCURRED DUE TO THE PROSTAR XL DEVICE NOT BEING ADVANCED ENOUGH IN THE ARTERY AT THE BEGINNING OF DEPLOYMENT, BUT COULD NOT BE CONFIRMED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN IS REPORTEDLY IN TRAINING IN THE USE OF THE PROSTAR XL DEVICE. 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 010076H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SHEATH: PROCEDURAL SHEATHS 20F AND 14F, HEPARIN