BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS TAPE VIO 60CM 10MM

    MDR report key: 9993658 · Received April 23, 2020

    Report

    Report Number
    2210968-2020-03450
    Event Type
    Injury
    Date Received
    April 23, 2020
    Report Date
    April 1, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PC-(B)(4). DATE SENT TO THE FDA: 5/8/2020. CORRECTED INFORMATION: B1, B2, H1 ¿ IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ¿ DOES THE SURGEON BELIEVE THAT ETHICON (POLYDIOXANONE SUTURE) PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS AND PATIENT DEATHS DESCRIBED IN THE ARTICLE? NO, THE SURGEON STATED: - AS PER ARTICLE, HE BELIEVES ETHICON PRODUCT WAS FANTASTIC. IN FACT HE WAS DISAPPOINTED THIS PRODUCT WAS NO LONGER AVAILABLE IN MARKET AND NOW HE HAS TO SWITCH TO ALTERNATIVE NON-ETHICON SUBSTITUTE. ¿ DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON (POLYDIOXANONE SUTURE) PRODUCTS USED IN THIS PROCEDURE? NO ¿ WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. NO ¿ PATIENT DEMOGRAPHICS SURGEON STATED THIS WAS IN PROVIDED IN THE ARTICLE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (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. ATTEMPTS ARE BEING MADE TO CLARIFY THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON (POLYDIOXANONE SUTURE) PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS AND PATIENT DEATHS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON (POLYDIOXANONE SUTURE) PRODUCTS USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. 14, 2011; 883¿886; DOI: ANN VASC SURG 2019; 60: 468¿473 DOI: HTTPS://DOI.ORG/10.1016/J.AVSG.2019.03.006. (B)(4).

    Description of Event or Problem · 1

    TITLE: OUTCOMES OF PATIENTS UNDERGOING SURGICAL MANAGEMENT OF MULTIPLE VENTRICULAR SEPTAL DEFECTS. THIS RETROSPECTIVE STUDY DISCUSSED THE OUTCOMES OF PATIENTS UNDERGOING SURGICAL MANAGEMENT OF MULTIPLE VENTRICULAR SEPTAL DEFECTS (VSD). BETWEEN 1998 AND 2015, 157 PATIENTS (MALE=81, FEMALE=76; MEAN AGE=2.2 MONTHS, AGE RANGE=2 DAYS ¿ 16.2 YEARS) UNDERWENT SURGICAL MANAGEMENT OF MULTIPLE VSDS. DURING PROCEDURE, BOTH NON-ABSORBABLE (GORE-TEX) AND ABSORBABLE PULMONARY ARTERY BANDS (PAB) (POLYDIOXANONE TAPE, 10-MM PDS; ETHICON) WERE USED, WITH THE MAJORITY OF NON-ABSORBABLE PABS PLACED BEFORE 2003, AFTER WHICH POINT THE UNIT PREFERRED THE USE OF ABSORBABLE PABS. ALL PABS WERE TIGHTENED, WHERE HEMODYNAMICALLY TOLERATED, REDUCING MAIN PULMONARY ARTERY (MPA) PRESSURE DISTAL TO THE BAND TO BETWEEN A THIRD AND A HALF OF SYSTEMIC ARTERIAL PRESSURE. THE BANDS WERE SECURED WITH EITHER 5/0 OR 6/0 POLYPROPYLENE SUTURES OR 2 LIGATING CLIPS (LIGACLIP; ETHICON) WITH CONVENTIONAL METHOD OF PAB PLACEMENT, ENSURING THAT IT CAUSED NO OBSTRUCTION OF THE LEFT AND RIGHT PULMONARY ARTERIES. REPORTED COMPLICATIONS INCLUDED SEPSIS (N=2). THE FIRST PATIENT WITH A TRANSPOSITION OF THE GREAT ARTERIES AND MULTIPLE VSDS, DIED OF SEPSIS POSTOPERATIVELY IN 2013 DESPITE REMOVAL OF THE ABSORBABLE PAB. THE OTHER PATIENT WITH DOUBLE DISCORDANCE AND MULTIPLE VSDS, PROVISIONALLY MANAGED WITH AN ABSORBABLE PAB, ULTIMATELY DIED OF SEPSIS IN THE SETTING OF DETERIORATING HEART FAILURE; RESIDUAL MPA STENOSIS (N=4) OF WHICH 1 PATIENT REQUIRED BALLOON DILATATION. IN CONCLUSION, SURGICAL TREATMENT OF MULTIPLE VSDS CAN BE PERFORMED WITH EXCELLENT SHORT- AND LONG-TERM SURVIVAL, AND NORMAL LATE FUNCTIONAL OUTCOME, HOWEVER, CARRIES A SIGNIFICANT RATE OF REOPERATION. THE RECENT INCLUSION OF ABSORBABLE PULMONARY ARTERY BANDS AND THE SANDWICH TECHNIQUE APPEAR SAFE AND ARE USEFUL ADJUNCTS IN THESE PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456731 PDS TAPE VIO 60CM 10MM POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention