BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT PER 30MM 4.0MM LARGE

    MDR report key: 12160575 · Received July 13, 2021

    Report

    Report Number
    9616099-2021-04704
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    July 5, 1997
    Report Date
    July 13, 2021
    Manufacturer
    CARDINAL HEALTH MEXICO
    Product Code
    FGE
    UDI-DI
    20705032057292
    PMA / PMN Number
    K911581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE DEVICE IS A PALMAZ STENT AND CATALOG NUMBER IS AVAILABLE BUT THE LOT NUMBER IS NOT AVAILABLE. THE ARTICLE WAS PUBLISHED IN 1994 AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. THE CITATION IS AS FOLLOWS: PRISCHL, F. C., WEBER, T., LENGLINGER, F., KIRCHGATTERER, A., WALLNER, M., & KRAMAR, R. (1997). CONSERVATIVE MANAGEMENT OF LATE PALMAZ STENT EMBOLIZATION TO THE PULMONARY ARTERY--A COMPLICATION AFTER PTA WITH STENT IMPLANTATION OF A FISTULA-DRAINING RIGHT SUBCLAVIAN VEIN STENOSIS. NEPHROLOGY, DIALYSIS, TRANSPLANTATION : OFFICIAL PUBLICATION OF THE EUROPEAN DIALYSIS AND TRANSPLANT ASSOCIATION - EUROPEAN RENAL ASSOCIATION, 12(9), 1994¿1996. HTTPS://DOI.ORG/10.1093/NDT/12.9.1996. AS REPORTED IN THE LITERATURE ARTICLE BY PRISCHL, F. C., WEBER, T., LENGLINGER, F., KIRCHGATTERER, A., WALLNER, M., & KRAMAR, R. (1997). CONSERVATIVE MANAGEMENT OF LATE PALMAZ STENT EMBOLIZATION TO THE PULMONARY ARTERY--A COMPLICATION AFTER PTA WITH STENT IMPLANTATION OF A FISTULA-DRAINING RIGHT SUBCLAVIAN VEIN STENOSIS. NEPHROLOGY, DIALYSIS, TRANSPLANTATION : OFFICIAL PUBLICATION OF THE EUROPEAN DIALYSIS AND TRANSPLANT ASSOCIATION - EUROPEAN RENAL ASSOCIATION, 12(9), 1994¿1996. HTTPS://DOI.ORG/10.1093/NDT/12.9.1994, SIX WEEKS AFTER IMPLANTATION OF A PALMAZ P308 8-12MM STENT, THE STENT EMBOLIZED TO THE PULMONARY ARTERY (PA). THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A RIGHT SUBCLAVIAN VEIN STENOSIS. APPROXIMATELY 46 DAYS AFTER IMPLANTATION, THE PATIENT REPORTED DISCOMFORT AND CHEST PAIN FOR THE PAST 3 DAYS. A CHEST XRAY REVEALED THE PALMAZ STENT HAD EMBOLIZED FROM THE RIGHT SUBCLAVIAN VEIN TO THE LEFT LOWER PA. PERFUSION SCANS SHOWED NO SIGNS OF PULMONARY EMBOLISM (PE) OR OCCLUSION OF THE PA. PATIENT WAS TREATED WITH A CONSERVATIVE APPROACH INSTEAD OF SURGERY. THE PATIENT WAS DIALYZED AS USUAL, INCLUDING THERAPEUTIC ANTICOAGULATION. HEPARIN WAS CONTINUED AFTER HAEMODIALYSIS AT A DOSE TO ACHIEVE A DOUBLING OF THE PARTIAL THROMBOPLASTIN TIME. FOUR DAYS LATER ORAL ANTI COAGULATION WITH PHENPROCOUMON WAS STARTED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AS SOON AS THE CONTINUOUS HEPARIN INFUSION COULD BE TERMINATED. REPEAT CHEST X-RAY WAS PERFORMED FOUR MONTHS AFTER IMPLANTATION AND THE MIGRATED STENT REMAINED IN STABLE POSITION. SIX MONTHS AFTER STENT EMBOLIZATION THE PATIENT IS DOING WELL WITHOUT ANY EVIDENCE OF PULMONARY CIRCULATION PROBLEMS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿STENT MIGRATION¿ AND ¿ CHEST PAIN¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. AS NO LOT NUMBER WAS SUPPLIED A PHR COULD NOT BE COMPLETED. IT IS POSSIBLE THE STENT WAS NOT ADEQUATELY EXPANDED TO FIT THE VESSEL, RESULTING IN STENT MIGRATION. THE SOURCE OF THE CHEST PAIN CAN NOT BE DETERMINED BUT MAY BE ASSOCIATED WITH MIGRATION OF THE STENT. ACCORDING TO THE POTENTIAL COMPLICATIONS IN THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿POTENTIAL COMPLICATIONS ASSOCIATED WITH PERIPHERAL ARTERY AND TRANSHEPATIC BILIARY STENT IMPLANTATION MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: STENT MIGRATION/EMBOLIZATION. TO ASSURE FULL EXPANSION, INFLATE TO AT LEAST THE RECOMMENDED NOMINAL PRESSURE AS SHOWN ON THE BALLOON CATHETER LABEL.¿ ACCORDING TO THE DIRECTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK ¿USING AN INFLATION DEVICE, STEADILY INFLATE THE BALLOON UNDER FLUOROSCOPY TO THE NOMINAL PRESSURE RECOMMENDED ON THE BALLOON CATHETER LABEL. EXPAND THE DIAMETER OF THE STENT TO THE DIAMETER OF THE REFERENCE VESSEL.¿ THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY PRISCHL, F. C., WEBER, T., LENGLINGER, F., KIRCHGATTERER, A., WALLNER, M., & KRAMAR, R. (1997). CONSERVATIVE MANAGEMENT OF LATE PALMAZ STENT EMBOLIZATION TO THE PULMONARY ARTERY--A COMPLICATION AFTER PTA WITH STENT IMPLANTATION OF A FISTULA-DRAINING RIGHT SUBCLAVIAN VEIN STENOSIS. NEPHROLOGY, DIALYSIS, TRANSPLANTATION : OFFICIAL PUBLICATION OF THE EUROPEAN DIALYSIS AND TRANSPLANT ASSOCIATION - EUROPEAN RENAL ASSOCIATION, 12(9), 1994¿1996. HTTPS://DOI.ORG/10.1093/NDT/12.9.1994, SIX WEEKS AFTER IMPLANTATION OF A PALMAZ P308 8-12MM STENT, THE STENT EMBOLIZED TO THE PULMONARY ARTERY (PA). THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A RIGHT SUBCLAVIAN VEIN STENOSIS. APPROXIMATELY 46 DAYS AFTER IMPLANTATION, THE PATIENT REPORTED DISCOMFORT AND CHEST PAIN FOR THE PAST 3 DAYS. A CHEST XRAY REVEALED THE PALMAZ STENT HAD EMBOLIZED FROM THE RIGHT SUBCLAVIAN VEIN TO THE LEFT LOWER PA. PERFUSION SCANS SHOWED NO SIGNS OF PULMONARY EMBOLISM (PE) OR OCCLUSION OF THE PA. PATIENT WAS TREATED WITH A CONSERVATIVE APPROACH INSTEAD OF SURGERY. THE PATIENT WAS DIALYZED AS USUAL, INCLUDING THERAPEUTIC ANTICOAGULATION. HEPARIN WAS CONTINUED AFTER HAEMODIALYSIS AT A DOSE TO ACHIEVE A DOUBLING OF THE PARTIAL THROMBOPLASTIN TIME. FOUR DAYS LATER ORAL ANTI COAGULATION WITH PHENPROCOUMON WAS STARTED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AS SOON AS THE CONTINUOUS HEPARIN INFUSION COULD BE TERMINATED. REPEAT CHEST X-RAY WAS PERFORMED FOUR MONTHS AFTER IMPLANTATION AND THE MIGRATED STENT REMAINED IN STABLE POSITION. SIX MONTHS AFTER STENT EMBOLIZATION THE PATIENT IS DOING WELL WITHOUT ANY EVIDENCE OF PULMONARY CIRCULATION PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054453 STENT PER 30MM 4.0MM LARGE CATHETER, BILIARY, DIAGNOSTIC FGE CARDINAL HEALTH MEXICO N/A UNK 20705032057292

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R