BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2060186 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02655
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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: EVALUATION OF THE RETURNED DEVICE FOUND THE HANDLE WAS IN THE PRE-DEPLOYED POSITION. THE SUTURE BIGHTS WERE STILL INSIDE THE COILED SUTURE LUMENS AND THERE WERE NO SLACKS ON THE SUTURES. THE INTERLOCKS WERE ROTATED PAST THE STAR MARKING ON THE BARREL. IF THE INTERLOCKS ARE NOT ENGAGED AND CORRECTLY ALIGNED WITH THE LOCKING INDENTS IN THE HUB, THE NEEDLES CANNOT PASS THROUGH THE BARREL. THE SHEATH APPEARED NORMAL AND THE GUIDE WIRE PATENCY WAS PERFORMED SUCCESSFULLY. THE INTERLOCKS WERE RETURNED TO ORIGINAL POSITION. THERE WAS EVIDENCE OF DRIED BLOOD ON THE COILED SUTURE LUMEN WHICH IS AN INDICATION THAT THE DEVICE WAS INSERTED INSIDE THE PATIENT. THE HANDLE WAS DEPLOYED AND ALL THE NEEDLES PRESENTED AT THE HUB. THERE WERE NO MANUFACTURING OR QUALITY DEFICIENCY DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS, THEREFORE, THE ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. IN ADDITION, A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS WITHIN THIS LOT FOR THE REPORTED DEVICE CODE AT THE TIME THIS INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR DEVICE ATTEMPTED PRE-CLOSURE PLACEMENT OF THE PROSTAR XL SUTURES IN THE ARTERIOTOMY SITE PRIOR TO AN INTERVENTIONAL THORACIC AORTIC STENT PLACEMENT PROCEDURE. REPORTEDLY, "THE DEVICE NOT BE REACHED TO DEPLOY THE NEEDLES; BLEEDING WAS IN THE PLACEMENT OF THE DEVICE IN THE ARTERY". A SECOND PROSTAR DEVICE WAS PLACED BEFORE PERFORMING THE ENDOPROSTHESIS PROCEDURE, LEAVING THE SUTURES SUSTAINED IN THE SURGICAL FIELD TO CARRY OUT THE CLOSURE, WHICH TURNED OUT SUCCESSFUL AFTER THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 910286H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 18F SHEATH