BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7374059 · Received March 27, 2018

    Report

    Report Number
    2210968-2018-71677
    Event Type
    Injury
    Date Received
    March 27, 2018
    Report Date
    March 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IS THERE AN ALLEGED DEFICIENCY AGAINST THE ETHICON PRODUCTS (PROLENE SUTURE, ETHIBOND SUTURE, BLAKE DRAIN, AND VICRYL SUTURE)? DOES THE PRINCIPAL INVESTIGATOR OPINE THAT THE AES ARE ATTRIBUTED TO THE USE OF ANY OF THE ETHICON PRODUCTS? IF SO, CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE INCLUDE: PRE-EXISTING CONDITIONS, EXACT PROCEDURE PERFORMED (IF NOT ALREADY SPECIFIED IN THE LITERATURE), SPECIFIC MEDICAL/ SURGICAL INTERVENTION PER PATIENT. THE PRODUCT CODE AND LOT NUMBER. CITATION: ANN THORAC SURG. 2014; 97: 782 8. DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2013.09.049.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: CONCOMITANT ROBOTIC MITRAL AND TRICUSPID VALVE REPAIR: TECHNIQUE AND EARLY EXPERIENCE¿ . AUTHORS: CLIFTON T. P. LEWIS, MD., RICHARD L. STEPHENS, PAC, CHARLES M. TYNDAL, CCP, JENNIFER L. CLINE, PHD, ARNP. CITATION: ANN THORAC SURG. 2014; 97: 782 8. DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2013.09.049. TRICUSPID VALVE REGURGITATION (TR) OFTEN OCCURS SECONDARY TO MITRAL INSUFFICIENCY. IT HAS BEEN CLEARLY ESTABLISHED THAT TRICUSPID VALVE REPAIR (TVP) SHOULD ACCOMPANY MITRAL VALVE REPAIR (MVP) WHEN MODERATE TR OF 2+ OR GREATER IS PRESENT. A TOTAL OF 50 PATIENTS (28 MALE AND 22 FEMALE; AGE RANGE: 64 TO 83 YEARS OLD) WITH ISOLATED MITRAL OR TRICUSPID INSUFFICIENCY WERE CONSIDERED CANDIDATES FOR THE PORT-ACCESS, ROBOTIC COMBINED RMVP RTVP. DURING THE OPERATIVE TECHNIQUE, ALL CANNULAS WERE PLACED IN THE GROIN USING SELDINGER TECHNIQUE UNDER A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GUIDANCE, THROUGH PROLENE PURSE STRINGS. DURING RMVP, THE MITRAL RINGS WERE SECURED WITH NITINOL CLIPS, AND LATER ALL ANNULOPLASTY SUTURES WERE TIED EXTRACORPOREALLY WITH ETHIBOND 2-0 SUTURES. DURING RTVP, A FR 28 CHEST TUBE WAS PLACED HIGH IN THE RIGHT PLEURAL SPACE THROUGH THE RIGHT ARM PORT AND A SOFT BLAKE DRAIN WAS PLACED IN THE PERICARDIAL SPACE THROUGH THE THIRD ARM PORT. AFTER HEMOSTASIS, THE OTHER PORTS AND THE GROIN WERE CLOSED WITH VICRYL SUTURE. THE REPORTED COMPLICATIONS INCLUDED HEMOTHORAX (N-6) WHICH REQUIRED RE-OPERATION, ILIAC ARTERY OCCLUSION (N-1) WHICH REQUIRED REVISION SURGERY, MITRAL VALVE REGURGITATION (MR) SECONDARY TO RING DEHISCENCE ASSOCIATED WITH NITINOL CLIP FRACTURE (N-2) WHICH REQUIRED REPEAT REPAIR; 1 PATIENT THROUGH A REDO ROBOTIC APPROACH AND 1 PATIENT THROUGH A STERNOTOMY, AND TR (N-11). IT WAS CONCLUDED THAT COMBINED RMVP-RTVP CAN BE PERFORMED SAFELY AND REPRODUCIBLY WITH ACCEPTABLE EARLY RESULTS. LONG-TERM FOLLOW-UP WILL BE NEEDED TO ESTABLISH THIS AS AN ALTERNATIVE TO TRADITIONAL STERNOTOMY APPROACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217497 BLAKE DRAIN UNKNOWN PRODUCT WOUND DRAINAGE SYSTEM KOG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention