BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 11795866 · Received May 10, 2021

    Report

    Report Number
    9612164-2021-01813
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 9, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    UDI-DI
    00763000240776
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW: THE CUSTOMER RETURNED 3 PHOTOGRAPHIC IMAGES FOR REVIEW. IMAGE 1: CONTAINED THE REPORTED PATIENT ACCESS SITE. THE IMAGE APPEARED TO BE POST-CLEANING. A DEPRESSION WAS NOTED IN THE CENTER OF THE DAMAGED AREA. REDNESS WAS ALSO NOTED AROUND THE WOUND. A RULER WAS ADJACENT TO THE ACCESS SITE, THE SITE MEASURED APPROXIMATELY 2CM ACROSS; ALTHOUGH THE RULER DID NOT INDICATE THE UNITS. THE PRESENCE OF ADHESIVE IN THE WOUND COULD NOT BE DETERMINED. IMAGE 2: CONTAINED THE REPORTED PATIENT ACCESS SITE. THE IMAGE APPEARED TO BE TAKEN PRIOR TO CLEANING. AN AREA OF BLACK SKIN WAS NOTED. THE SURROUNDING TISSUE WAS RED. DRAINAGE FROM THE SITE WAS ALSO OBSERVED. THE OBSERVED WOUND WAS CONSISTENT WITH THE REPORTED NECROSIS AT THE ACCESS SITE. THE PRESENCE OF ADHESIVE IN THE WOUND COULD NOT BE DETERMINED. IMAGE 3: CONTAINED THE DEVICE LABEL STICKER WHICH IS ADHERED TO THE OUTSIDE PACKAGING OF THE VENASEAL DEVICE. THE LOT NUMBER IN THE IMAGE WAS CONSISTENT WITH THE REPORTED 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 · 1

    DATE OF EVENT: MONTH AND YEAR VALID. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN USED VENASEAL FOR TREATMENT OF THE PATIENT¿S SHORT SAPHENOUS VEIN (SSV). THE VEIN IS REPORTED TO HAVE CLOSED. IT IS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP AND NECROSIS WAS NOTED AT THE ACCESS SITE. THE PHYSICIAN CHECKED AND CONFIRMED THAT THERE WAS NO ADHESIVE IN THE SUB CUTANEOUS TISSUE THAT COULD HAVE CAUSED THIS. THE AFFECTED AREA WAS CLEANED, WRAPPED AND THE PATIENT WAS GIVEN ANTIBIOTICS. IT IS REPORTED THE ISSUE IS STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692582 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND VS-404 61671 00763000240776

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention