BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI AVANTI PLUS

    MDR report key: 2060029 · Received April 15, 2011

    Report

    Report Number
    9616099-2011-00255
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 20, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT A PATIENT EXPERIENCED A PSEUDOANEURYSM ONE WEEK AFTER AN EXOSEAL VASCULAR CLOSURE DEVICE WAS USED AFTER AN ANGIOPLASTY PROCEDURE. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THERE WERE NO VISIBLE SIGNS OF DAMAGE WITH THE VASCULAR CLOSURE DEVICE (VCD). THE SHEATH USED WAS A 6F AVANTI SHEATH. NO RESISTANCE/FRICTION WAS EXPERIENCED AS THE VCD WAS ADVANCED THROUGH THE SHEATH. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING. AN AUDIBLE "CLICK" WAS HEARD. AN ADEQUATE BLEED-BACK SIGNAL WAS OBSERVED. THE PLUG DEPLOYMENT BUTTON WAS FULLY DEPRESSED AND THE PLUG DEPLOYED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE VCD. THE PATIENT DID NOT EXPERIENCE ANY BLEEDING COMPLICATIONS. THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. IT WAS UNKNOWN IF FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY. THE PHYSICIAN USED THE EXOSEAL AND EVERYTHING WENT NORMALLY. ONE WEEK AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A PSEUDOANEURYSM. THE EVENT WAS TREATED WITH AN ARTERIAL SUTURE. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. THE STERILE LOT NUMBER FOR THE AVANTI SHEATH IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. PSEUDO-ANEURYSMS ARE A KNOWN PROCEDURAL COMPLICATION ASSOCIATED WITH GAINING VASCULAR ACCESS FOR PERCUTANEOUS INTERVENTIONS. THIS TYPE OF COMPLICATION IS ASSOCIATED WITH PRACTITIONER TECHNIQUE; THE NUMBER OF STICKS NEEDED TO GAIN ACCESS, AND IS MORE PREVALENT IN OBESE PATIENTS. THE USE OF ANTICOAGULATION DURING AND AFTER THE PROCEDURE MAY ALSO CONTRIBUTE TO THIS TYPE OF EVENT. WITH THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE EVENT BUT GIVEN THE TIME FRAME OF THE EVENT PATIENT COMPLIANCE WITH DISCHARGE INSTRUCTIONS (NO HEAVY LIFTING AFTER THE PROCEDURE) AND OR ANTI-PLATELET THERAPY MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.

    Description of Event or Problem · 1

    APPROXIMATELY ONE WEEK AFTER THE EXOSEAL WAS USED TO CLOSE THE FEMORAL ARTERY, THE PATIENT EXPERIENCED A PSEUDOANEURYSM THAT WAS TREATED WITH ARTERIAL SUTURE. THERE WAS NO VISIBLE SIGNS OF DAMAGE WITH THE VASCULAR CLOSURE DEVICE (VCD). THE CATHETER SHEATH INTRODUCER USED WAS A 6FR AVANTI +. NO RESISTANCE/FRICTION WAS EXPERIENCED AS THE VCD WAS ADVANCED THROUGH THE SHEATH. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING. AN AUDIBLE "CLICK" WAS HEARD. AN ADEQUATE BLEED-BACK SIGNAL WAS OBSERVED. THE PLUG DEPLOYMENT BUTTON WAS FULLY DEPRESSED. THE PLUG DEPLOYED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE VCD. THE PROCEDURE WAS NOT ABORTED PRIOR TO PLUG DEPLOYMENT. THE VCD WAS REMOVED WITH THE SHEATH AS A SINGLE UNIT. THE PATIENT DID NOT EXPERIENCE ANY BLEEDING COMPLICATIONS. THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. IT WAS UNKNOWN IF FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY. THE PHYSICIAN USED THE EXOSEAL AND EVERYTHING WENT NORMALLY. ONE WEEK AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A PSEUDOANEURYSM. THE PROCEDURE TYPE WAS ANGIOPLASTY. A 6FR AVANTI + CATHETER SHEATH INTRODUCER WAS USED. TREATMENT FOR THE PSEUDOANEURYSM WAS ARTERIAL SUTURE. THE PRODUCT WAS DISCARDED BECAUSE THE PSEUDOANEURYSM DID NOT APPEAR WHEN THE EXOSEAL WAS USED. IT APPEARED DAYS AFTER USE. THE PATIENT'S PHYSICIAN DISCOVERED THE PSEUDOANEURYSM AND SENT THE PATIENT BACK TO THE DOCTOR THAT PERFORMED THE PROCEDURE. IT WAS REPORTED THAT AT THE TIME OF USE, IT WAS NOT POSSIBLE TO KNOW IF SOMETHING WAS WRONG WITH THE EXOSEAL; THEREFORE, THE DEVICE WAS DISCARDED ACCORDING TO STANDARD PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI AVANTI PLUS CARDIOLOGY VASCULAR ACCESS (DRE) DRE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention