BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 4223933 · Received November 4, 2014

    Report

    Report Number
    2024168-2014-07190
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 10, 2014
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF THE DEVICE OPERATING DIFFERENTLY THAN EXPECTED WAS CONFIRMED. 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 ASSOCIATED NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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 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 PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, PERCLOSE PLACEMENT OF THE SUTURE WAS ATTEMPTED IN THE COMMON FEMORAL ARTERY USING THE PROSTAR XL DEVICE. REPORTEDLY, WHEN TYING THE KNOT, THE GREEN SUTURES BECAME TRAPPED WITH ONE OF THE NEEDLES. A SECOND PROSTAR XL DEVICE WAS PREPARED USING THE PERCLOSE TECHNIQUE AND SET ASIDE. THE ARTERIOTOMY WAS 6F. THE SHEATH WAS UPSIZED TO 18F FOR THE TAVI PROCEDURE. AFTER THE TAVI PROCEDURE WAS COMPLETED, THE SUTURES OF THE SECOND PROSTAR XL DEVICE ACHIEVED HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY 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
    707846 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40128K1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATH: 6F, 18F, HEPARIN