BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2152763 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04815
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE WAS STILL IN THE PRE-DEPLOYED POSITION AND THERE WAS NO SLACK ON THE SUTURES. THE MARKER TUBE APPEARED NORMAL AND THE MARKER PORT WAS NOT OCCLUDED. DURING THE INVESTIGATION, THE MARKING AND GUIDE WIRE PATENCY WERE PERFORMED AND THE DEVICE WAS FOUND TO BE PATENT. THE PROBABLE CAUSE FOR THE ABSENCE OF BLOOD FLOW AT THE MARKER LUMEN ARE AS FOLLOWS: IF THE MARKER PORT IS NOT PLACED CORRECTLY IN THE ARTERIAL LUMEN, THE POSSIBLE PLACING OF THE MARKER PORT AGAINST THE ARTERIAL SIDEWALL, TISSUE OBSTRUCTING THE MARKER PORT, OR A DEEP ARTERY. IT WAS REPORTED THAT THE COMMON FEMORAL ARTERY WAS CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. DURING MANUFACTURING, THE MARKING OF EACH DEVICE IS SUBJECTED TO AN INSPECTION AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INVESTIGATION, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION; THEREFORE, THE CAUSE FOR REPORTED EVENT COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A PROSTAR XL DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THERE WAS NO BLOOD FLOW IN THE MARKER LUMEN. THE DEVICE WAS FLUSHED AND REINSERTED, BUT NO FLOW WAS ACHIEVED. A SECOND PROSTAR XL DEVICE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT IS NOT REPORTED IF THE PHYSICIAN WAS PROFICIENT IN THE USE OF THE PROSTAR XL DEVICE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THAT THE PROCEDURE WAS A AORTIC VALVE REPLACEMENT PROCEDURE AND THE VESSEL WAS A CALCIFIED COMMON FEMORAL ARTERY. IT WAS ALSO REPORTED THAT THE PHYSICIAN BELIEVES THAT THERE WAS A BLOOD CLOT THAT BLOCKED THE BLOOD FLOW AT THE MARKER LUMEN. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR XL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 030096H

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention SHEATH: 18F