BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALEO BILIARY STENT

    MDR report key: 7144523 · Received December 22, 2017

    Report

    Report Number
    2020394-2017-01801
    Event Type
    Death
    Date Received
    December 22, 2017
    Date of Event
    October 1, 2015
    Report Date
    December 22, 2017
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FGE
    PMA / PMN Number
    K052132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. ARTICLE REVIEW: IT WAS IDENTIFIED IN THE ARTICLE THAT A VALEO STENT WAS IMPLANTED IN A 19 DAY OLD INFANT PATIENT WITH CONGENITAL HEART DISEASE (HYPOPLASTIC LEFT HEART SYNDROME) WHO UNDERWENT DUCTEOUS ARTERIOSIS (DA) STENTING VIA VENOUS FEMORAL APPROACH. THE VALEO STENT WAS PLANNED TO BE IMPLANTED BUT WAS BLOCKED IN THE TRICUSPID VALVE. SURGICAL REMOVAL OF THE STENT WAS PERFORMED AND DA STENTING WAS SUBSEQUENTLY PERFORMED THROUGH THE PULMONARY ARTERY. THE PROCEDURE WAS COMPLETED, HOWEVER THE PATIENT EXPIRED A FEW DAYS LATER FROM MULTI-ORGAN FAILURE. HASCOET, S., JALAL, Z., BARUTEAU, A., MAURI, L., CHALARD, A., BOUZGUENDA, I., . . . FRAISSE, A. (2015). STENTING IN PAEDIATRIC AND ADULT CONGENITAL HEART DISEASES: A FRENCH MULTICENTRE STUDY IN THE CURRENT ERA. ARCHIVES OF CARDIOVASCULAR DISEASE, (108), 650-660. INVESTIGATION SUMMARY: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. PER THE INFORMATION STATED IN THE RELATED JOURNAL ARTICLE, THE VALEO STENT WAS IMPLANTED IN A (B)(6) OLD INFANT WITH CONGENITAL HEART DISEASE. IT SHOULD BE NOTED THAT, PER THE INSTRUCTIONS FOR USE FOR THE VALEO STENT SYSTEM, THE DEVICE IS CONTRAINDICATED AGAINST THE USE IN CHILDREN, OR ADOLESCENTS UNDER THE AGE OF 21. IT IS UNKNOWN IF THE USE IN AN INFANT CONTRIBUTED TO THE REPORTED ISSUE. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE REPORTED ADVANCEMENT ISSUES COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR VALEO® VASCULAR STENT STATES: INDICATIONS: THE VALEO® VASCULAR STENT IS INTENDED FOR PRIMARY STENTING IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE PERIPHERAL ARTERIES. CONTRAINDICATIONS: PREGNANT WOMEN, NURSING MOTHERS, CHILDREN, OR ADOLESCENTS UNDER 21 YEARS OF AGE. WARNINGS: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING THE INSERTION PROCESS, DO NOT FORCE PASSAGE. IF RESISTANCE OCCURS DURING MOVEMENT THROUGH THE SHEATH/GUIDING CATHETER, THE STENT/CATHETER SHOULD BE WITHDRAWN CAREFULLY. DURING IMPLANTATION, IF RESISTANCE OCCURS AFTER THE STENT HAS EXITED THE SHEATH/GUIDING. CATHETER OR IF THE STENT CANNOT BE DELIVERED TO THE TARGET LOCATION, ATTEMPTS TO RETRACT THE STENT/CATHETER INTO THE SHEATH/GUIDING CATHETER MAY RESULT IN DISLODGEMENT AND EMBOLIZATION OF THE STENT. THE STENT/CATHETER/SHEATH/GUIDING CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. PRECAUTIONS: ONLY PHYSICIANS FAMILIAR WITH THE COMPLICATIONS, SIDE EFFECTS, AND HAZARDS COMMONLY ASSOCIATED WITH ANGIOGRAPHY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) SHOULD USE THIS DEVICE. INSPECT THE VALEO® VASCULAR STENT AND DELIVERY SYSTEM PRIOR TO USE TO VERIFY THAT THE STENT HAS NOT BEEN DAMAGED DURING SHIPMENT OR HANDLING AND THAT THE DEVICE DIMENSIONS ARE SUITABLE FOR THE SPECIFIC PROCEDURE. DO NOT ATTEMPT TO REMOVE OR ADJUST THE STENT ON THE DELIVERY SYSTEM. THE INFLATED DIAMETER OF THE BALLOON USED DURING STENT EXPANSION SHOULD APPROXIMATE THE DIAMETER OF THE TARGET ARTERY. TO ENSURE FULL EXPANSION OF THE STENT, THE BALLOON SHOULD BE INFLATED TO A MINIMUM OF THE NOMINAL PRESSURE. OVER-EXPANSION OF THE STENT CAN RESULT IN PERFORATION OR RUPTURE OF THE ARTERY. THE MINIMAL ACCEPTABLE ACCESSORY FRENCH SIZE IS PRINTED ON THE PACKAGE LABEL. DO NOT ATTEMPT TO PASS THE STENT/DELIVERY SYSTEM THROUGH A SMALLER SIZE ACCESSORY THAN INDICATED ON THE LABEL. REFER TO THE INSTRUCTIONS FOR USE SUPPLIED WITH ANY INTERVENTIONAL DEVICES TO BE USED IN CONJUNCTION WITH THE VALEO® VASCULAR STENT FOR THEIR INTENDED USES, CONTRAINDICATIONS, AND POTENTIAL COMPLICATIONS. POTENTIAL COMPLICATIONS: PERSONS WITH ALLERGIC REACTIONS TO STAINLESS STEEL MAY SUFFER AN ALLERGIC RESPONSE TO THIS IMPLANT. STENT MIGRATION, SEPSIS/INFECTION, SPASM OF THE VESSEL, EMBOLI, THROMBOSIS, OR ACUTE OCCLUSION, INTIMAL FLAP, INJURY, DISSECTION, PERFORATION, OR RUPTURE OF A VESSEL, LATE DEVELOPMENT OF A PSEUDOANEURYSM AT THE CATHETERIZATION SITE, BLEEDING OR HEMATOMA AT THE PUNCTURE SITE, DEATH. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN ARCHIVES OF CARDIOVASCULAR DISEASE TITLED, "STENTING IN PAEDIATRIC AND ADULT CONGENITAL HEART DISEASES: A FRENCH MULTICENTRE STUDY IN THE CURRENT ERA", DURING A STENT DEPLOYMENT PROCEDURE, THE STENT COULD NOT BE ADVANCED OVER THE GUIDEWIRE AND WAS SURGICALLY REMOVED. ANOTHER STENT PLACEMENT WAS PERFORMED THROUGH THE PULMONARY ARTERY. THE PATIENT REPORTEDLY EXPIRED A FEW DAYS LATER FROM MULTI-ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922327 VALEO BILIARY STENT BALLOON EXPANDABLE STENT FGE BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DA Death