BEUDAMED
    FDA Adverse Event Death Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 5059628 · Received September 7, 2015

    Report

    Report Number
    9681442-2015-00151
    Event Type
    Death
    Date Received
    September 7, 2015
    Date of Event
    April 28, 2015
    Report Date
    August 14, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    PMA / PMN Number
    P080007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER #P080007. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT WAS MADE TO EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE. IN THIS CASE, NO SAMPLE WAS NOT RETURNED FOR EVALUATION. THREE IMAGES WERE PROVIDED. BASED ON THE EVALUATION OF THE IMAGES, NO DEFICIENCY OF THE IMPLANTED STENT WAS IDENTIFIED. NO INDICATION WAS FOUND THAT THE IMPLANTED STENT MIGHT HAVE CONTRIBUTED TO THE DEATH OF THE PATIENT OR THAT THE STENT HAS FAILED TO FUNCTION AS INTENDED. POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT HAVE BEEN EVALUATED. AS THE REPORTED EVENT WAS FOUND TO BE AN ISOLATED INCIDENT, NO PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS COULD HAVE BEEN REVIEWED. ON THE BASIS OF THE INVESTIGATION PERFORMED, A DEFINITE ROOT CAUSE FOR THE REPORTED CLINICAL EVENT COULD NOT BE DETERMINED. ACCORDING TO THE IFU SUPPLIED WITH THIS DEVICE, THE BARD E-LUMINEXX VASCULAR STENT IS INDICATED FOR USE IN THE ILIAC AND FEMORAL ARTERIES. THE REPORTED APPLICATION REPRESENTS AN OFF-LABEL USE OF THE DEVICE. THE SAFETY AND EFFECTIVENESS OF THE DEVICE FOR A TREATMENT AS DESCRIBED HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT IMPLANTATION WAS SUCCESSFUL BUT THE PATIENT EXPIRED 8 DAYS AFTER SURGERY. AS REPORTED A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE (TIPS PROCEDURE) WAS INITIALLY PERFORMED TO TREAT A PATIENT LIVER CIRRHOSIS, PORTAL HYPERTENSION AND ASCITES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED 14 DAYS POST SUCCESSFUL IMPLANTATION OF THE VASCULAR STENT. AS REPORTED, THE PATIENT PRESENTED WITH A COMPLEX MEDICAL HISTORY INCLUDING HEPATIC CIRRHOSIS, PORTAL HYPERTENSION AND ASCITIS. THE PATIENT UNDERWENT A TIPS PROCEDURE AS WELL AS A CORONARY GASTRIC VEIN EMBOLIZATION. THE TIPS PROCEDURE INCLUDED THE IMPLANTATION OF THE VASCULAR STENT AT THE LEVEL OF THE PORTAL VEIN. REPORTEDLY, THE PATIENT SHOWED SYMPTOMS OF VOMITING THE SAME DAY AFTER STENT IMPLANTATION. TRANSFUSIONS WERE GIVEN AND AN ABDOMINAL PARACENTESIS WAS PERFORMED. THE PERIPHERAL EDEMA WAS WORSENING AND SERUM AMMONIA LEVELS WERE INCREASED. THE PATIENT EXPIRED 14 DAYS AFTER PLACEMENT OF THE VASCULAR STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590798 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWI1763

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death