BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT 5F VASCULAR STENT

    MDR report key: 20949863 · Received December 17, 2024

    Report

    Report Number
    9681442-2024-00440
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 19, 2024
    Report Date
    January 28, 2025
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE LIFESTENT 5F VASCULAR STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510K NUMBER FOR THE LIFESTENT 5F VASCULAR STENT SYSTEM PRODUCTS IS IDENTIFIED IN D2 AND G4. H10: MANUFACTURING REVIEW: THE LOT HISTORY RECORDS OF THIS LOT WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. ADDITIONAL COMPLAINTS HAVE NOT BEEN REPORTED FOR THIS LOT, PREVIOUSLY. INVESTIGATION SUMMARY: THE RETURNED SAMPLE IS IN USED CONDITION WITHOUT STENT THAT REPORTEDLY HAS BEEN DEPLOYED INSIDE PATIENT. THE INNER CATHETER CARDAN TUBE IS BROKEN TWICE IN THE MID SECTION AND AT THE DISTAL END; THE BROKEN-OFF DISTAL END INCLUDING TIP IS PART OF THE SAMPLE RETURN. ELONGATION OF THE CARDAN TUBE CLOSE THE DISTAL BREAK SITE INDICATES INCREASED TENSILE FORCE. PROVIDED IMAGES DEMONSTRATE THE BROKEN OFF SEGMENT INSIDE THE VESSEL DISTAL TO THE STENT. THE INVESTIGATION LEADS TO CONFIRMED RESULT FOR ELONGATION, BREAK, AND DETACHMENT OF THE INNER CATHETER CARDAN TUBE INSIDE VESSEL. LIMITED INFORMATION IS AVAILABLE, BUT THE STENT DEPLOYED CORRECTLY, AND THE UPON REMOVAL THE GUIDEWIRE WAS FOUND WITH A BEND; ELONGATION OF THE CARDAN TUBE INDICATED INCREASE TENSILE FORCE. A MANUFACTURING RELATED ROOT CAUSE WAS CONSIDERED; THEREFORE, THE LOT HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. BASED ON THE INFORMATION AVAILABLE A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE INVESTIGATION OF THE PROVIDED INFORMATION, THE INVESTIGATION IS CLOSED AS CONFIRMED FOR ELONGATION, BREAK AND DETACHMENT OF THE INNER CATHETER CARDAN TUBE. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: IN REVIEWING THE RELEVANT LABELING FOR THIS PRODUCT, THE POTENTIAL ISSUE WAS FOUND ADDRESSED. THE INSTRUCTIONS FOR USE STATES: 'DO NOT CONSTRICT THE DELIVERY SYSTEM DURING STENT DEPLOYMENT. IF EXCESSIVE FORCE IS FELT DURING STENT DEPLOYMENT, DO NOT FORCE THE STENT SYSTEM. REMOVE THE STENT SYSTEM AND REPLACE WITH A NEW UNIT.' REGARDING PRE DILATION THE INSTRUCTIONS FOR USE STATES: 'PRE-DILATATION OF THE LESION WITH A BALLOON DILATATION CATHETER IS RECOMMENDED.' UNDER MATERIALS REQUIRED THE INSTRUCTIONS FOR USE STATES: '5F (1.67 MM) OR LARGER INTRODUCER SHEATH (¿); 0.014-INCH (0.36 MM) - 0.035-INCH (0.89 MM) DIAMETER GUIDEWIRE'. REGARDING INSERTION AND REMOVAL DIFFICULTY OF THE DELIVERY SYSTEM THE INSTRUCTIONS FOR USE STATES: 'IF RESISTANCE IS MET DURING STENT SYSTEM INTRODUCTION, THE STENT SYSTEM SHOULD BE WITHDRAWN AND ANOTHER STENT SYSTEM SHOULD BE USED.', AND 'IF RESISTANCE IS MET WHILE RETRACTING THE DELIVERY SYSTEM OVER A GUIDEWIRE, REMOVE THE DELIVERY SYSTEM AND GUIDEWIRE TOGETHER.' HOLDING AND HANDLING OF THE SYSTEM THROUGHOUT DEPLOYMENT WAS FOUND SUFFICIENTLY DESCRIBED. 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: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE LIFESTENT 5F VASCULAR STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510K NUMBER FOR THE LIFESTENT 5F VASCULAR STENT SYSTEM PRODUCTS IS IDENTIFIED IN D2 AND G4. H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. HOWEVER, PHOTO AND IMAGE WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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 THAT DURING A STENT PLACEMENT PROCEDURE, THE GUIDEWIRE THAT WAS BEING USED DURING STENT IMPLANTATION WAS FOUND TO HAVE A BEND. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION OF STENT WAS SPLIT AND REMAINED INSIDE THE PATIENT. REPORTEDLY, IT WAS EXTRACTED COMPLETELY FROM THE PATIENT'S INTERIOR. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE GUIDEWIRE THAT WAS BEING USED DURING STENT IMPLANTATION WAS FOUND TO HAVE A BEND. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION OF STENT WAS SPLIT AND REMAINED INSIDE THE PATIENT. REPORTEDLY, IT WAS EXTRACTED COMPLETELY FROM THE PATIENT'S INTERIOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267136 LIFESTENT 5F VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANFZ1237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown