BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMINEXX 3 VASCULAR STENT

    MDR report key: 7875383 · Received September 13, 2018

    Report

    Report Number
    9681442-2018-00170
    Event Type
    Injury
    Date Received
    September 13, 2018
    Report Date
    November 7, 2018
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    PMA / PMN Number
    P080007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. JOURNAL ARTICLE REVIEW: BETWEEN JANUARY 2010 AND MAY 2017, 154 PATIENTS WHO RECEIVED TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) CREATION WERE PROSPECTIVELY ANALYZED. FLUENCY AND LUMINEXX STENTS WERE USED IN THIS STUDY. MOST TIPS WERE CREATED BY USING 8 MM X 60 MM EPTFE COVERED STENTS AND 8 MM X 60 MM BARE STENTS. ALL PATIENTS WERE FOLLOWED UP AT 1, 3, 6 AND 12 MONTHS AND THEN YEARLY THEREAFTER. SHUNT DYSFUNCTION WAS DEFINED AS STENOSIS (A REDUCTION IN THE CALIBER OF THE STENT BY =50%) OR OCCLUSION OF THE STENT. SIXTY-THREE PATIENTS DEVELOPED SHUNT DYSFUNCTION, 30 HAD SHUNT STENOSIS, 33 HAD SHUNT OCCLUSION. CAUSES OF SHUNT DYSFUNCTION INCLUDED STENT KINKING AT PORTAL END (12) AND AT HEPATIC END (10), THROMBOSIS AT HEPATIC END (31), PORTAL END (16) AND WITHIN THE SHUNT (6). SIXTY-TWO PATIENTS UNDERWENT TIPS REVISIONS, INCLUDING BALLOON ANGIOPLASTY (23), THROMBECTOMY, THROMBOASPIRATION AND THROMBOLYSIS COMBINED WITH BALLOON ANGIOPLASTY (30), NEW STENT GRAFT DEPLOYMENT (13) AND FAILED TIPS REVISIONS WERE OBSERVED IN THREE PATIENTS. WAN, Y-M., LI, Y-H., XU, Y., WU, H-M., LI, Y-C., WU, X-N. & YANG, J-H. (2018). PREDICTORS OF SHUNT DYSFUNCTION AND OVERALL SURVIVAL IN PATIENTS WITH VARICEAL BLEEDING TREATED WITH TRANSJUGULAR PORTOSYSTEMIC SHUNT CREATION USING THE FLUENCY STENT GRAFT. ACADEMIC RADIOLOGY, 25 (7), 925-934. HTTPS://DOI.ORG/10.1016/J.ACRA.2017.11.020. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION OF THE ARTICLE AND THE PROVIDED IMAGES WITHIN THIS ARTICLE A DEVICE DEFICIENCY COULD NOT BE IDENTIFIED. AN INDICATION FOR A DEVICE RELATION OF THE THROMBOSIS, OCCLUSION AND STENOSIS COULD NOT BE DETERMINED. THE INVESTIGATION WILL BE CLOSED WITH INCONCLUSIVE RESULT. IN THIS CASE THE STENT WAS USED FOR A TIPS PROCEDURE WHICH REPRESENTS AN OFF LABEL USE. A MANUFACTURING RELATED ROOT CAUSE WAS CONSIDERED, HOWEVER, THE LOT NUMBER WAS NOT AVAILABLE SO THAT A REVIEW OF MANUFACTURING DOCUMENTS WAS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE A DEFINITE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED. LABELING REVIEW: THE LATEST VERSION OF THE IFU (INSTRUCTION FOR USE) FOR VASCULAR INDICATION WAS REVIEWED. IN REVIEWING THE RELEVANT LABEL FOR THIS PRODUCT, THE POTENTIAL ISSUE WAS FOUND ADDRESSED. THE IFU STATES: 'ALL COMPLICATIONS THAT HAVE BEEN REPORTED IN ASSOCIATION WITH VASCULAR STENTS MAY ALSO OCCUR DURING OR AFTER INSERTION OF A BARD LUMINEXX* 3 VASCULAR STENT. THESE INCLUDE (...) THROMBOSIS (...) EARLY STENT OCCLUSION AND RESTENOSIS.' THE IFU STATES THAT THE PRODUCT IS INDICATED FOR USE IN THE ILIAC AND FEMORAL ARTERIES.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN ACADEMIC RADIOLOGY TITLED 'PREDICTORS OF SHUNT DYSFUNCTION AND OVERALL SURVIVAL IN PATIENTS WITH VARICEAL BLEEDING TREATED WITH TRANSJUGULAR PORTOSYSTEMIC SHUNT CREATION USING THE FLUENCY STENT GRAFT' THAT STENT KINK, THROMBOSIS AND STENOSIS OCCURRED, WHICH WAS TREATED WITH ANGIOPLASTY, THROMBECTOMY, THROMBOLYSIS AND NEW STENT PLACEMENT. PATIENT STATUS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. MEDICAL IMAGES WERE PROVIDED IN THE ARTICLE AND A REVIEW IS CURRENTLY UNDERWAY. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. JOURNAL ARTICLE CITATION: WAN, Y-M., LI, Y-H., XU, Y., WU, H-M., LI, Y-C., WU, X-N. & YANG, J-H. (2018). PREDICTORS OF SHUNT DYSFUNCTION AND OVERALL SURVIVAL IN PATIENTS WITH VARICEAL BLEEDING TREATED WITH TRANSJUGULAR PORTOSYSTEMIC SHUNT CREATION USING THE FLUENCY STENT GRAFT. ACADEMIC RADIOLOGY, 25 (7), 925-934. HTTPS://DOI.ORG/10.1016/J.ACRA.2017.11.020. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN ACADEMIC RADIOLOGY, AN ARTICLE TITLED, ¿PREDICTORS OF SHUNT DYSFUNCTION AND OVERALL SURVIVAL IN PATIENTS WITH VARICEAL BLEEDING TREATED WITH TRANSJUGULAR PORTOSYSTEMIC SHUNT CREATION USING THE FLUENCY STENT GRAFT, THAT STENT KINK, THROMBOSIS AND STENOSIS OCCURRED, WHICH WAS TREATED WITH ANGIOPLASTY, THROMBECTOMY, THROMBOLYSIS AND NEW STENT PLACEMENT. PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715969 LUMINEXX 3 VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention