BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2980279 · Received February 27, 2013

    Report

    Report Number
    2024168-2013-01144
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED NEEDLES FAILING TO DEPLOY WAS CONFIRMED AS ANALYSIS OF THE DEVICE REVEALED CLAMPING MARKS ON ONE OF THE RETURNED COILED SUTURE LUMEN SUGGESTING THAT THE COILED SUTURE LUMEN WAS CLAMPED PRIOR TO NEEDLE DEPLOYMENT, WHICH WOULD PREVENT THE NEEDLES FROM BEING FULLY DEPLOYED. THE PROSTAR XL DEVICE INSTRUCTIONS FOR USE STATE UNDER NEEDLE DEPLOYMENT NOT TO CLAMP THE SUTURE LUMEN WITH A HEMOSTAT OR OTHER INSTRUMENT. DOING SO WILL PREVENT SUTURE DEPLOYMENT. BASED ON VISUAL INSPECTION 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT INDICATED DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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 WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ESTIMATED DATE OF EVENT - THE CUSTOMER REPORTED THE EVENT OCCURRED IN THE MONTH OF (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A TRANSLUMINAL AORTIC VALVE IMPLANTATION PROCEDURE (TAVI), PRE-CLOSE PLACEMENT OF THE SUTURES WAS ACHIEVED IN RIGHT COMMON FEMORAL ARTERY THROUGH A 9 FR SIZED ACCESS SITE USING A PROSTAR XL DEVICE. DURING NEEDLE DEPLOYMENT, ALTHOUGH THE DEVICE WAS HELD AT AN ANGLE OF 45-DEGREES TO THE LONGITUDINAL PLANE OF THE ARTERY, THE NEEDLES WOULD NOT EJECT (DEPLOY) THROUGH THE VESSEL WALL. THE DEVICE WAS REMOVED AND THE SUTURES FROM A SECOND PROSTAR XL DEVICE WERE DEPLOYED. AFTER CONCLUSION OF THE TAVI PROCEDURE, THE KNOTS OF THE SECOND PROSTAR XL DEVICE WERE ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE HOSPITAL DURATION OF THE PATIENT WAS NOT EXTENDED AS A RESULT OF THE DEVICE ISSUE. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, BUT WAS NOT CHANGED DUE TO THE DEVICE ISSUE. 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
    84821 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20928K1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SHEATH: 9-FRENCH CORDISASPIRIN