BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLGRAFT¿

    MDR report key: 2761034 · Received September 26, 2012

    Report

    Report Number
    2134265-2012-06182
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K003100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD BEEN FULLY DEPLOYED FROM THE DEVICE AND WAS NOT RETURNED. THE OUTER SHEATH WAS RETRACTED APPROXIMATELY 90 MM PROXIMAL TO THE DISTAL TIP. IT WAS NOTED THAT THE INNER SHAFT WAS KINKED AT APPROXIMATELY 60 MM PROXIMAL TO ITS DISTAL END. NO ISSUES WERE NOTED WITH THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT MIGRATION OCCURRED. THE RIGHT RENAL ARTERY WAS STENTED WITH A 5.0X19MM EXPRESS STENT. IT WAS NOTED THAT THERE WAS A DISSECTION IN THE INFERIOR AORTA AND A 14X50 12FR WALLGRAFT STENT WAS DEPLOYED TO COVER THE DISSECTION. HOWEVER, AFTER RETRIEVING THE DELIVERY SYSTEM, THE WALLGRAFT STENT MIGRATED UPWARDS AGAINST CIRCULATION IN THE AORTA ABOVE THE CELIAC TRUNK AND THE SUPERIOR MESENTERIC ARTERY. NO DAMAGE WAS NOTED AFTER CONTROL WITH CONTRAST. AFTER ANOTHER FINAL CONTROL WITH CONTRAST, THE STENT MIGRATED DOWNWARDS JUST IN FRONT OF THE RENAL ARTERIES. THE PHYSICIAN INFLATED A 12MM MUSTANG BALLOON INSIDE THE WALLGRAFT STENT; HOWEVER, THE BALLOON WAS TOO SMALL, MAKING IT POSSIBLE TO DETERMINE THAT THE WALLGRAFT STENT WOULD BE FULLY OPENED AT 14MM. THE PHYSICIAN THEN TRIED TO FURTHER DEPLOY THE STENT WITH ADDITIONAL BALLOON CATHETERS; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. IT WAS NOTED THAT THE RENAL CONTROL AT THIS POINT WAS OKAY WITH GOOD PERFUSION. THE PHYSICIAN FURTHER INFLATED THE LOWER PART OF THE WALLGRAFT STENT WITH A XXL BALLOON JUST AT THE LEVEL OF THE DISSECTION. AGAIN, IT WAS NOTED THAT CONTROL AND RENAL PERFUSION WERE GOOD AND THE INTERVENTION WAS COMPLETED; HOWEVER, TWO HOURS LATER THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND A SCAN INDICATED THAT THERE WAS NO BLOOD FLOW AND AN INFARCTION TO THE KIDNEY DUE TO THE LOCATION OF THE WALLGRAFT STENT AGAINST THE RIGHT RENAL ARTERY. HOWEVER, THE RENAL FUNCTION WAS OKAY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT MIGRATION OCCURRED. THE RIGHT RENAL ARTERY WAS STENTED WITH A 5.0X19MM EXPRESS STENT. IT WAS NOTED THAT THERE WAS A DISSECTION IN THE INFERIOR AORTA AND A 14X50 12FR WALLGRAFT STENT WAS DEPLOYED TO COVER THE DISSECTION. HOWEVER, AFTER RETRIEVING THE DELIVERY SYSTEM, THE WALLGRAFT STENT MIGRATED UPWARDS AGAINST CIRCULATION IN THE AORTA ABOVE THE CELIAC TRUNK AND THE SUPERIOR MESENTERIC ARTERY. NO DAMAGE WAS NOTED AFTER CONTROL WITH CONTRAST. AFTER ANOTHER FINAL CONTROL WITH CONTRAST, THE STENT MIGRATED DOWNWARDS JUST IN FRONT OF THE RENAL ARTERIES. THE PHYSICIAN INFLATED A 12MM MUSTANG BALLOON INSIDE THE WALLGRAFT STENT; HOWEVER, THE BALLOON WAS TOO SMALL, MAKING IT POSSIBLE TO DETERMINE THAT THE WALLGRAFT STENT WOULD BE FULLY OPENED AT 14MM. THE PHYSICIAN THEN TRIED TO FURTHER DEPLOY THE STENT WITH ADDITIONAL BALLOON CATHETERS; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. IT WAS NOTED THAT THE RENAL CONTROL AT THIS POINT WAS OKAY WITH GOOD PERFUSION. THE PHYSICIAN FURTHER INFLATED THE LOWER PART OF THE WALLGRAFT STENT WITH A XXL BALLOON JUST AT THE LEVEL OF THE DISSECTION. AGAIN, IT WAS NOTED THAT CONTROL AND RENAL PERFUSION WERE GOOD AND THE INTERVENTION WAS COMPLETED; HOWEVER, TWO HOURS LATER, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND A SCAN INDICATED THAT THERE WAS NO BLOOD FLOW AND AN INFARCTION TO THE KIDNEY DUE TO THE LOCATION OF THE WALLGRAFT STENT AGAINST THE RIGHT RENAL ARTERY. HOWEVER, THE RENAL FUNCTION WAS OKAY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLGRAFT¿ PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY H965520320 15465352

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 5.0X19MM EXPRESS STENT