BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 19584237 · Received June 21, 2024

    Report

    Report Number
    9681442-2024-00157
    Event Type
    Death
    Date Received
    June 21, 2024
    Date of Event
    January 1, 2019
    Report Date
    July 5, 2024
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS 01-JAN-1900 FOR THE MDR SUBMISSION REQUIREMENT. H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. NO X-RAY IMAGES WERE PROVIDED FOR REVIEW. BASED ON THE INVESTIGATION OF THE PROVIDED INFORMATION, THE INVESTIGATION IS CLOSED AS INCONCLUSIVE. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: IT WAS NOT KNOWN FOR WHICH PRODUCT OF THE BARE METAL STENT GROUP THESE EVENTS WERE REPORTED. IF IT INVOLVED A LIFESTENT, THE SPECIFIC TYPE OF LIFESTENT IS UNKNOWN. DEPLOYMENT PROCEDURE INCLUDING ACCESSORIES TO BE USED WAS FOUND SUFFICIENTLY DESCRIBED. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR ARE FOUND DESCRIBED, SUCH AS AMPUTATION, HEMATOMA, RENAL IMPAIRMENT, MALPOSITION, RESTENOSIS, DISTAL EMBOLIZATION, AND SURGICAL INTERVENTION. H10: LIN, TING-CHAO, PO-LIN CHEN, CHIU-YANG LEE, CHUN-CHE SHIH, AND I-MING CHEN (2019). COVERED STENT VERSUS BARE-METAL STENTS FOR CHRONIC TOTAL OCCLUDED LONG COMPLICATED FEMOROPOPLITEAL LESIONS: A 2-YEAR SINGLE CENTER REVIEW. JOURNAL OF THE CHINESE MEDICAL ASSOCIATION. 82(1): 44-49. DOI: 10.1097/JCMA.0000000000000005. H11: B3, B5, H6 (METHOD). H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Additional Manufacturer Narrative · 0

    H10: DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS (B)(6) 1900 FOR THE MDR SUBMISSION REQUIREMENT. H10: TING-CHAO LIN, PO-LIN CHEN, CHIU-YANG LEE, CHUN-CHE SHIH, I-MING CHEN (2019). COVERED STENT VERSUS BARE-METAL STENTS FOR CHRONIC TOTAL OCCLUDED LONG COMPLICATED FEMOROPOPLITEAL LESIONS: A 2-YEAR SINGLE CENTER REVIEW. JOURNAL OF THE CHINESE MEDICAL ASSOCIATION, 82(1):44-49. DOI: 10.1097/JCMA.0000000000000005. H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE "JOURNAL OF CHINESE MEDICAL ASSOCIATION" TITLED "COVERED STENT VERSUS BARE-METAL STENTS FOR CHRONIC TOTAL OCCLUDED LONG COMPLICATED FEMOROPOPLITEAL LESIONS: A 2-YEAR SINGLE CENTER REVIEW". THAT SOMETIME POST A STENT PLACEMENT IN THE OCCLUDED SUPERFICIAL FEMORAL ARTERY LESIONS, TEN PATIENTS WERE REPORTEDLY DIED. THE PRIMARY CAUSE OF DEATHS WERE NOT PROVIDED AND THE RELATIONSHIP OF THE DEATHS WITH THE DEVICE AND PROCEDURE WERE UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE "JOURNAL OF CHINESE MEDICAL ASSOCIATION" TITLED "COVERED STENT VERSUS BARE-METAL STENTS FOR CHRONIC TOTAL OCCLUDED LONG COMPLICATED FEMOROPOPLITEAL LESIONS: A 2-YEAR SINGLE CENTER REVIEW". THAT SOMETIME POST STENT PLACEMENT PROCEDURE FOR CHRONIC TOTAL OCCLUDED LONG COMPLICATED FEMOROPOPLITEAL LESIONS, THERE WERE TEN OCCURRENCES OF DEATH. THE PRIMARY CAUSE OF DEATH WAS NOT PROVIDED AND THE RELATIONSHIP OF THE DEATH WITH THE DEVICE AND PROCEDURE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157648 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death