BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3698468 · Received March 25, 2014

    Report

    Report Number
    2024168-2014-01771
    Event Type
    Injury
    Date Received
    March 25, 2014
    Date of Event
    January 1, 2008
    Report Date
    January 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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. PATIENT AGE ESTIMATED AS 83 YEARS OLD. (PLUS OR MINUS 8 YEARS); PATIENT GENDER ESTIMATED AS MALE. (67 OF 124 PATIENTS MALE); DATE OF EVENT AND THERAPY ESTIMATED. THE ARTICLE INDICATES THE PROCEDURES WERE PERFORMED BETWEEN JANUARY 2008 AND FEBRUARY 2013. PERIPHERAL ARTERIAL DISEASE-COMMERCIAL VALVE:(44%); PARTNER COHORT B:(19%); PREVIOUS CEREBROVASCULAR ACCIDENT OR TRANSIENT ISCHEMIC ATTACK-COMMERCIAL VALVE: (15%); PARTNER COHORT B: (24%). PREVIOUS ANGIOPLASTY-COMMERCIAL VALVE: (33%); PARTNER COHORT B: (26%). PREVIOUS CORONARY ARTERY BYPASS GRAFTING-COMMERCIAL VALVE: (29%); PARTNER COHORT B: (24%). THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE TWO PERCLOSE PROGLIDE DEVICES, WERE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ARE NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS REPORTED THAT A 22-FRENCH OR 24-FRENCH DELIVERY SHEATH WAS USED DEPENDING ON THE SIZE OF THE VALVE (23 OR 26MM). PER THE INDICATIONS FOR USE SECTION OF THE PROSTAR XL 10F PVS SYSTEM INSTRUCTIONS FOR USE, THE PROSTAR XL 10F PVS SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE AND REDUCING THE TIME TO HEMOSTASIS AND TIME TO AMBULATION (PATIENT WALKS TEN FEET) OF PATIENTS WHO HAVE UNDERGONE CATHETERIZATION PROCEDURES USING 8.5F TO 10F SHEATHS.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. "COMMERCIAL VERSUS PARTNER STUDY EXPERIENCE WITH THE TRANSFEMORAL EDWARDS SAPIEN VALVE FOR INOPERABLE PATIENTS WITH SEVERE AORTIC STENOSIS" IT WAS REPORTED THAT A SINGLE-CENTER RETROSPECTIVE STUDY WAS ANALYZED FROM APRIL 2012 TO FEBRUARY 2013, 69 CONSECUTIVE INOPERABLE PATIENTS WITH SYMPTOMATIC SEVERE AORTIC STENOSIS WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A COMMERCIAL SAPIEN VALVE THROUGH THE TRANSFEMORAL ROUTE WERE INCLUDED IN THE COMMERCIAL GROUP. THE COMPARATIVE GROUP CONSISTED OF 55 INOPERABLE PATIENTS FROM PARTNER COHORT B WHO WERE TREATED WITH A SAPIEN VALVE AT THE SAME INSTITUTION FROM JANUARY 2008 TO AUGUST 2011. IN CASES USING THE COMPLETE PERCUTANEOUS APPROACH, AFTER WIRE INTRODUCTION, THE ARTERIOTOMY ACCESS SITE WAS PREPARED WITH EITHER A SINGLE PROSTAR XL DEVICE OR 2 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE DEVICES. A 22FR OR 24FR DELIVERY SHEATH WAS USED DEPENDING ON THE SELECTED SIZE OF THE VALVE (23 OR 26 MM). THE LITERATURE REPORTS EVENTS OF IN-HOSPITAL BLEEDING, RETROPERITONEAL BLEEDING, AND ARTERIAL PERFORATIONS THAT WERE SURGICALLY TREATED. CORRELATION WITH A SPECIFIC CLOSURE DEVICE (PROSTAR XL OR PERCLOSE PROGLIDE DEVICE) WAS NOT PROVIDED. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174647 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SHEATHS: 22-FRENCH, 24-FRENCH, HEPARIN