BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1905143 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02952
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED DEVICE YIELDED THE FOLLOWING OBSERVATIONS: THE HANDLE WAS IN BACKDOWN POSITION. THERE WERE CLAMP MARKS FOUND ON THE COILED SUTURE LUMEN AND MARKER TUBE. THE NEEDLE SLOTS AND SUTURE PORTS APPEARED NORMAL. THERE WERE NEEDLE STRIKE MARKS ON THE BARREL FACE AND GUIDE SHOULDER. BASED ON THE INVESTIGATION FINDINGS, THE CLAMP MARKS FOUND ON THE COILED SUTURE LUMEN AND THE COLLAPSED SUTURE TUBE AT THE HUB AREA, IS AN INDICATION THAT A HEMOSTAT WAS APPLIED BEFORE THE NEEDLE DEPLOYMENT. CLAMPING OF THE SUTURE TUBE INTERFERED WITH SUTURE DEPLOYMENT AND NEEDLE TRAJECTORY CAUSING THE NEEDLE TO BEND AND STRIKE THE BARREL FACE. THE INSTRUCTIONS FOR USE (IFU) UNDER DEVICE PLACEMENT AND NEEDLE DEPLOYMENT STATES: DO NOT CLAMP THE SUTURE LUMEN WITH A HEMOSTAT OR OTHER INSTRUMENT. DOING SO WILL PREVENT THE SUTURE DEPLOYMENT. THERE WERE NO ABNORMAL OBSERVATIONS WITH THE CONDITION OF THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THEREFORE, THE ROOT CAUSE FOR THIS EVENT INCORRECT TECHNIQUE. THERE WERE NO MANUFACTURING OR QUALITY ISSUES DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF THE DEVICE MASTER RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE NEEDLES WOULD NOT DEPLOY. THE GUIDE WIRE WAS REINSERTED AND ANOTHER PROSTAR XL WAS USED TO ACHIEVE HEMOSTASIS. IT IS NOT KNOWN HOW HEMOSTASIS WAS ACHIEVED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9. "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THIS LITERATURE IS FROM (B)(6). THIS CASE IS 5TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS RCA BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN ISR BUT IT WAS A CTO LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, FOUR CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 94MM AND THE DIAMETER OF THE STENT WAS 3.0MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP (6 ~ 9MONTHS AFTER THE IMPLANT) ANGIOGRAM, THE STENT FRACTURE AND RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN FRACTURE SITE AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL TYPE. THE %DS WAS 68% AND POPMA ET AL CLASSIFICATION WAS III. TO TREAT THE RESTENOSIS, CYPHER (DETAILS UNKNOWN) WAS IMPLANTED. AFTER THAT, NO RECURRENT RESTENOSIS WAS OBSERVED. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 860286H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention