BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2983357 · Received February 28, 2013

    Report

    Report Number
    2024168-2013-01173
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. DATE OF OCCURRENCE IS ENTERED AS DATE OF PUBLICATION - (B)(6) 2013. THE ARTICLE INDICATES THE PROCEDURES WERE PERFORMED BETWEEN 2009 TO 2011. IT IS INDICATED THAT THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE PROGLIDE DEVICES REFERENCED ARE BEING FILED A SEPARATE MEDWATCH MFR NUMBER. PREDICTING THE LEARNING CURVE AND FAILURES OF TOTAL PERCUTANEOUS ENDOVASCULAR AORTIC ANEURYSM REPAIR. JOURNAL OF VASCULAR SURGERY. VOLUME 57, NUMBER 1, JANUARY 2013. CARLOS F. BECHARA, MD, MS, NEAL R. BARSHES, MD, MPH, GEORGE PISIMISIS MD, HUITING CHEN, MD, TAEMEE PAK, BS, PETER H. LIN, MD, AND PANAGIOTIS KOUGIAS, MD.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED ON REVIEW OF THE ARTICLE, PREDICTING THE LEARNING CURVE AND FAILURES OF TOTAL PERCUTANEOUS ENDOVASCULAR AORTIC ANEURYSM REPAIR. IT WAS REPORTED THAT A SINGLE CENTER RETROSPECTIVE STUDY IDENTIFIED A TOTAL OF 99 PATIENTS WHO UNDERWENT PEVAR (PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR) OVER A 30 MONTH PERIOD STARTING IN MARCH OF 2009. OF THE 99 PATIENTS THERE WERE 18 PERCUTANEOUS CLOSURE FAILURES. THE DEVICE FAILURES WERE REPORTED AS: SUTURE PARTIALLY PULLING THROUGH THE ARTERIOTOMY, INABILITY TO PUSH THE KNOT ALL THE WAY DOWN TO THE LEVEL OF THE ARTERY. CLOSURE DEVICES USED WERE PROGLIDE AND PROSTAR. CLINICAL OUTCOMES WERE AS FOLLOWS: 16 CASES- INTRAOPERATIVE CONVERSION TO FC-EVAR (FEMORAL CUT DOWN-ENDOVASCULAR ANEURYSM REPAIR) TO ACHIEVE HEMOSTASIS. SIXTEEN CASES- INTRAOPERATIVE CONVERSION TO FC-EVAR (FEMORAL CUT DOWN-ENDOVASCULAR ANEURYSM REPAIR) TO ACHIEVE HEMOSTASIS. IN FC-EVAR CASES A SHEATH AND SOMETIMES AN OCCLUSIVE BALLOON WERE USED TO ACHIEVE HEMOSTASIS WHILE FEMORAL EXPOSURE WAS PERFORMED. TWO CASES- SMALL BOVINE PATCH TO REPAIR FEMORAL ARTERY; 2 OF THE 18 HAD POSTOPERATIVE COMPLICATIONS: 1- THROMBOSIS ONE DAY POSTOPERATIVE, REQUIRED THROMBECTOMY AND PATCH ANGIOPLASTY; 1- OPEN REPAIR FOR PSEUDOANEURYSM ON SECOND DAY POSTOPERATIVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85560 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 12F TO 24F, HEPARIN, PROTAMINE