BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3840308 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03438
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - IMPROPER OR INCORRECT PROCEDURE OR METHOD. INDICATION FOR USE. A 6F SHEATH WAS USED IN THE PROCEDURE. PER THE IFU, THE PROSTAR XL 10F PVS SYSTEM IS DESIGNED FOR USE IN CONJUNCTION WITH 8.5 TO 24F SHEATHS. IT WAS REPORTED THAT THE DEVICE WAS USED ON THE MILDLY CALCIFIED COMMON FEMORAL ARTERY. THE PROSTAR XL 10F PVS SYSTEM INSTRUCTIONS FOR USE, STATES: THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE TO DEPLOY THE NEEDLES COULD NOT BE CONFIRMED. THE HANDLE WAS PULLED STRAIGHT OUT TO RE-DEPLOY THE NEEDLES WITHOUT DIFFICULTY. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NONCONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT WAS REPORTED THAT A 6F SHEATH WAS USED IN THE PROCEDURE. THE PROSTAR XL INSTRUCTIONS FOR USE, STATES: THE PROSTAR XL 10F PVS SYSTEM IS DESIGNED FOR USE IN CONJUNCTION WITH 8.5 TO 24F SHEATHS. 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 REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, SUTURE PLACEMENT WAS ATTEMPTED USING THE PRECLOSE TECHNIQUE IN THE MILDLY CALCIFIED RIGHT FEMORAL ARTERY. REPORTEDLY, THE PROSTAR XL BECAME JAMMED AND WOULD NOT ALLOW THE NEEDLES TO EXIT, BUT RATHER THEY WERE STUCK PART WAY IN. THE DEVICE WAS REMOVED AND THE SUTURES OF A SECOND PROSTAR XL DEVICE WERE PREPLACED USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS 6F. THE SHEATH WAS UPSIZED TO 9F AND 18F FOR THE TAVI PROCEDURE. AFTER COMPLETION OF THE TAVI PROCEDURE THE SUTURES OF THE SECOND PROSTAR XL DEVICE ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, AN UNKNOWN DEVICE FAILURE OCCURRED. THE METHOD OF ACHIEVING HEMOSTASIS IS NOT SPECIFIED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. IT IS REPORTEDLY NOT KNOWN IF THE PHYSICIAN IS TRAINED IN THE USE OF THE PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318127 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30828K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 9F, 18F