BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2854891 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07639
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. CT AND ANGIOGRAM IMAGES OF THE ABDOMEN DEMONSTRATING THE GRAFT IMPLANT PRE AND POST FOR A AAA WERE REVIEWED. CT AND ANGIOGRAM IMAGES OF BOTH FEMORAL ARTERIES APPEARED NORMAL WITH NO DISSECTION OR EXTRAVASATIONS INTO THE SOFT TISSUE. THE BLEEDING OF THE FEMORAL ARTERY WAS NOT DEMONSTRATED IN THESE IMAGES. THE BLEEDING MAY HAVE OCCURRED BELOW THE EPIGASTRIC ARTERY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. IT WAS REPORTED THE LEFT AND RIGHT COMMON FEMORAL ARTERIES WERE MILDLY CALCIFIED. PER THE INSTRUCTIONS FOR USE, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS SUCCESSFUL IN THE LEFT AND RIGHT COMMON FEMORAL ARTERIES USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE ARTERIOTOMIES WERE 10F AND THE VESSELS WERE MILDLY CALCIFIED. THE SHEATH SIZE WAS UPSIZED TO 16F ON THE LEFT SIDE AND 20F ON THE RIGHT SIDE FOR THE AAA PROCEDURE. REPORTEDLY, SHORTLY BEFORE THE END OF THE PROCEDURE THE PATIENT'S BLOOD PRESSURE DECREASED, THE PATIENT WAS TREATED WITH ARTERENOL. BOTH PUNCTURE SITES ACHIEVED HEMOSTASIS AT THE END OF THE INDEX PROCEDURE. REPORTEDLY, AFTER THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE A EXTRAPERITONEAL HEMATOMA WAS NOTED ON THE LEFT SIDE AND REQUIRED RESUSCITATION. AFTER THE PATIENT WAS STABILIZED, A COMPUTERIZED TOMOGRAPHY WAS PERFORMED, NO BLEEDING WAS SEEN. A FEMORAL ANGIOGRAM WAS PERFORMED AND THE SOURCE OF BLEEDING WAS FOUND IN THE LEFT FEMORAL ARTERY. A GRAFTMASTER STENT WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT REQUIRED A BLOOD TRANSFUSION AND HOSPITALIZATION WAS EXTENDED DUE TO THE RESUSCITATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROSTAR DEVICE. 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 20716K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SHEATH: 8F, 10F, 16F, 20F, HEPARIN, ARTERENOL