BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ ECHO

    MDR report key: 5302437 · Received December 16, 2015

    Report

    Report Number
    1213643-2015-00425
    Event Type
    Injury
    Date Received
    December 16, 2015
    Date of Event
    November 20, 2015
    Report Date
    January 30, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K1010851
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED INDICATES THAT A BARD/DAVOL DEVICE WAS NOT USED IN THE PROCEDURE IN QUESTION. THE MANUFACTURER OF THE IMPLANTED DEVICE HAS BEEN NOTIFIED.

    Additional Manufacturer Narrative · 1

    THIS IS AN ADDENDUM TO THE INITIAL MDR. BASED ON THE ADDITIONAL INFORMATION PROVIDED THIS IS AN OBESE PATIENT WHO APPROXIMATELY EIGHTEEN MONTHS POST IMPLANT EXPERIENCED A HERNIA RECURRENCE AND UNDERWENT A REVISION PROCEDURE. THE SURGEON DID NOT HAVE AN OPINION AS TO WHAT MIGHT HAVE CAUSED THE RECURRENCE. A LOT NUMBER FOR THE BARD DEVICE IN QUESTION WAS REQUESTED, HOWEVER NOT PROVIDED. THIS COMPLAINT REMAINS INCONCLUSIVE AS NO DEFINITIVE CONCLUSIONS CAN BE MADE, BASED ON THE ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS IS AN ADDENDUM TO THE PREVIOUSLY SUBMITTED INITIAL AND SUPPLEMENTAL MDR. THIS COMPLAINT REMAINS INCONCLUSIVE AS NO DEFINITIVE CONCLUSIONS CAN BE MADE BASED ON THE ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THE REPORTED EVENT. PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED, THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE IFU AS A POSSIBLE COMPLICATION. AS REPORTED THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION PROVIDED, AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. IT IS POSSIBLE THAT THE HERNIA RECURRENCE RESULTED IN CHANGE TO THE MESH STRUCTURE. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    THIS IS AN ADDENDUM TO THE PREVIOUSLY SUBMITTED MDRS TO DOCUMENT THE RECEIPT OF A LETTER FROM AN ATTORNEY WHO IS NOW REPRESENTING THE PATIENT. THE INFORMATION PROVIDED INCLUDED AN IMPLANT TRACKING LOG DATED (B)(6) 2014, THE DATE IN WHICH A BARD/DAVOL DEVICE WAS ALLEGEDLY IMPLANTED. THE IMPLANT TRACKING LOG INCLUDES TRACKING LABELS FOR MULTIPLE ITEMS USED TO TREAT THE PATIENT INCLUDING A HERNIA REPAIR DEVICE FROM ANOTHER MANUFACTURER. A BARD/DAVOL DEVICE WAS NOT USED IN THE PROCEDURE IN QUESTION.

    Description of Event or Problem · 1

    THIS IS AN ADDENDUM TO THE INITIAL MDR AS ADDITIONAL INFORMATION HAS BEEN PROVIDED IN FOLLOW UP: ON (B)(6) 2014 - THE PATIENT WAS IMPLANTED WITH A BARD VENTRALIGHT ST W/ ECHO FOR TREATMENT OF A HERNIA. ON (B)(6) 2015 - THE PATIENT UNDERWENT AN OPEN INCISIONAL REVISION PROCEDURE DUE TO A HERNIA RECURRENCE AND WAS IMPLANTED WITH A BARD VENTRIO ST MESH.

    Description of Event or Problem · 1

    THIS IS AN ADDENDUM TO THE INITIAL MDR AS ADDITIONAL INFORMATION HAS BEEN PROVIDED IN FOLLOW UP: ON (B)(6) 2014 - THE PATIENT WAS IMPLANTED WITH A BARD VENTRALIGHT ST W/ ECHO FOR TREATMENT OF A HERNIA. ON (B)(6) 2015 - THE PATIENT UNDERWENT AN OPEN INCISIONAL REVISION PROCEDURE DUE TO A HERNIA RECURRENCE AND WAS IMPLANTED WITH A BARD VENTRIO ST MESH. THIS IS A ADDENDUM TO THE SUPPLEMENTAL MDR AS ADDITIONAL INFORMATION HAS BEEN PROVIDED IN FOLLOW UP: IN 2016 - THE PATIENT ALLEGES THAT SHE HAS ONGOING PAIN SINCE THE EXPLANT PROCEDURE. SHE STATED THAT HER SURGEON TOLD HER THAT THE PAIN SHE HAS AT THIS TIME IS RELATED TO SCAR TISSUE. PATIENT IS REPORTED TO BE TAKING A PRESCRIPTION MEDICATION FOR PAIN TREATMENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL: IT WAS REPORTED THAT THE PATIENT HAD A HERNIA RECURRENCE. DURING THE REVISION PROCEDURE IT IS NOTED THAT THE MESH HAD "WORN AWAY IN THE MIDDLE PART." AN ALTERNATIVE MESH WAS USED TO TREAT THE HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828959 VENTRALIGHT ST W/ ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention