BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3171076 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03751
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    January 1, 2008
    Report Date
    May 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DATE OF EVENT ESTIMATED AS DATE OF THE STUDY REFERENCED BY CHIU ET AL., 2008. RESULTS FOR CLOSER: 60.0 % (2/5) FAILURE RATE FOR ANTEGRADE PUNCTURE CLOSURE. THREE DEPLOYMENT FAILURES IN FIVE ANTEGRADE PUNCTURES; TWO WERE RESCUED BY INSERTION OF A SECOND DEVICE. RESULTS FOR STARCLOSE: 10.0% (4/40) FAILURE RATE FOR ANTEGRADE PUNCTURE CLOSURE. MINOR COMPLICATIONS AFTER CLOSURE OF PUNCTURE SITE- 22.5 % (9/40). NO ADDITIONAL INFORMATION WAS PROVIDED. THE STUDY INDICATED THAT THE PERCLOSE PROGLIDE DEVICES WERE DEPLOYED IN ANTEGRADE FEMORAL ARTERY PUNCTURE SITES. THE PROGLIDE DEVICE INSTRUCTIONS FOR USE STATES UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED, IN PATIENTS WITH ANTEGRADE PUNCTURES. THE OTHER ABBOTT VASCULAR DEVICES, REFERENCED, WERE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS. SCHMELTER CHRISTOPHER; LIEBL ANDREA; POULLOS NEKTARIOS; RUPPERT VOLKER; VORWERK DIERK (CARDIOVASC INTERVENT RADIOL (2013) 36:659-668): SUITABILITY OF EXOSEAL VASCULAR CLOSURE DEVICE FOR ANTEGRADE FEMORAL ARTERY PUNCTURE SITE CLOSURE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING CORRECTION IS MADE: RESULTS FOR TECHSTAR: (B)(4) SUCCESS RATE FOR ANTEGRADE PUNCTURE CLOSURE (NOT FAILURE RATE AS INITIALLY REPORTED). RESULTS FOR PROSTAR PLUS: (B)(4) SUCCESS RATE FOR ANTEGRADE PUNCTURE CLOSURE (NOT FAILURE RATE AS INITIALLY REPORTED).

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. THE ARTICLE PURPOSE IS DISCUSSION OF THE NON-ABBOTT EXOSEAL VASCULAR CLOSURE DEVICE. HOWEVER, THE ARTICLE ALSO DISCUSSES THE USE OF ABBOTT VASCULAR CLOSURE DEVICES FOR CLOSURE OF ANTEGRADE PUNCTURE SITES IN DIAGNOSTIC AND INTERVENTIONAL PROCEDURES, EVALUATED FROM A SMALL NUMBER OF PUBLICATIONS; THE DEVICES ARE PROGLIDE, TECHSTAR, PROSTAR PLUS, CLOSER, AND STARCLOSE DEVICES. RESULTS FOR PROGLIDE: 38.7% (12/31) FAILURE RATE FOR ANTEGRADE PUNCTURE CLOSURE. MINOR COMPLICATIONS AFTER CLOSURE OF PUNCTURE SITE- 35.5% (11 /31). RESULTS FOR TECHSTAR: 96.3% (77/80) FAILURE RATE FOR ANTEGRADE PUNCTURE CLOSURE. MAJOR COMPLICATIONS AFTER CLOSURE OF PUNCTURE SITE 1.3% (1/80). MINOR COMPLICATIONS AFTER CLOSURE OF PUNCTURE SITE- 6.3% (5/80). RESULTS FOR PROSTAR PLUS: 96.3% (77/80) FAILURE RATE FOR ANTEGRADE PUNCTURE CLOSURE. MAJOR COMPLICATIONS AFTER CLOSURE OF PUNCTURE SITE 1.3% (1/80). MINOR COMPLICATIONS AFTER CLOSURE OF PUNCTURE SITE- 6.3% (5/80). A RETROPERITONEAL BLEED WAS REPORTED; HOWEVER, CORRELATION OF THIS AND OTHER EVENTS TO THE TECHSTAR VERSUS THE PROSTAR PLUS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270606 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention