BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABRE VENOUS SELF-EXPANDING STENT SYSTEM

    MDR report key: 17709463 · Received September 8, 2023

    Report

    Report Number
    2183870-2023-00333
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 17, 2023
    Report Date
    December 12, 2023
    Manufacturer
    COVIDIEN
    Product Code
    QAN
    PMA / PMN Number
    P200026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: THE PATIENT WAS UNDERGOING THROMBOLYSIS OF RIGHT LOWER LEG DVT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    IMAGE ANALYSIS: MULTIPLE IMAGES WERE REVIEWED FROM AN APPARENT VENOGRAM OF THE RIGHT ILIAC AND RLE. MULTIPLE IMAGES SHOW WHAT APPEARS TO BE SCATTERED DVT IN THE RIGHT FEMORAL AND SUPERFICIAL FEMORAL VEINS. THERE IS A DEVICE IN THE RIGHT SFV, WITH MARKER BANDS PRESENT. THERE ARE NO IMAGES WITH ANY PORTION OF A STENT VISIBLE. IN ONE IMAGE THERE APPEARS TO BE EXSANGUINATION OF CONTRAST AROUND THE RIGHT FEMORAL VEIN. IT IS DIFFICULT TO TELL WHETHER THIS BLEEDING IS SECONDARY TO VESSEL PERFORATION OR CONTRAST LEAKING FROM THE SHEATH AROUND THE VEIN. THERE ARE NO IMAGES THAT APPEAR TO BE BELOW THE KNEE AND NO IMAGES THAT APPEAR TO BE THE SMALL SAPHENOUS VEIN. OF NOTE, USING AN ABRE STENT IN THE SSV IS OFF-LABEL. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS VISUAL INSPECTION: THE RED LOCKING PIN WAS SECURE IN THE HANDLE OF THE RETURNED DEVICE SIZE INDICATED ON THE STRAIN RELIEF WAS 9F 18MM X 80MM . THE ABRE DEVICE RETURNED LOADED IN A 9F INTRODUCER BIOLOGICS WERE OBSERVED BETWEEN THE INTRODUCER AND THE ABRE DEVICE DAMAGE WAS OBSERVED ON THE INTRODUCER DAMAGE WAS OBSERVED TO THE SILVER RETRACTABLE SHEATH BIOLOGICS WERE OBSERVED ON THE DISTAL SECTION OF THE CATHETER. THE STENT WAS FLOWERED AND PARTIALLY DEPLOYED IMAGE ANALYSIS: STILL IMAGE EVALUATION FIVE STILL IMAGES WERE PROVIDED FOR EVALUATION. IN ONE OF THE IMAGES PROVIDED YOU CAN SEE THAT THE STENT IS PARTIALLY DEPLOYED AND THERE IS DAMAGE TO THE DISTAL SECTION OF THE SILVER RETRACTABLE SHEATH AND BIOLOGICS ON THE DEVICE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN ABRE STENT FOR THE TREATMENT OF A 20MM (MAX) FIBROUS LESION IN THE DISTAL REGION OF THE RIGHT SHORT SAPHENOUS VEIN (SSV). THERE WAS MILD TORTUOSITY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DEVICE FAILED TO CROSS. THE DEVICE WAS INITIALLY TWISTED TO TRY AND RETRIEVE IT BACK INTO THE SHEATH HOWEVER WHEN THIS WAS NOT POSSIBLE THE SHEATH WAS REMOVED AND THE ENTIRE DEVICE WAS WITHDRAWN FROM THE PUNCTURE SITE. DEFORMATION WAS NOTED ON THE CATHETER/DELIVERY SYSTEM TIP, BUNCHING AND STRETCHING WERE OBSERVED. DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. STENT DEPLOYED FURTHER ON REMOVAL OF ENTIRE DEVICE. THE PATIENT WAS LEFT UNTREATED. VESSEL PERFORATION OCCURRED. PATIENT WAS GIVEN HEAVY PAIN RELIEVE AND WAS VASOVAGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112631 ABRE VENOUS SELF-EXPANDING STENT SYSTEM STENT, ILIAC VEIN QAN COVIDIEN B372780

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention