BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20546471 · Received October 28, 2024

    Report

    Report Number
    2210968-2024-11147
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    January 1, 2023
    Report Date
    October 28, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # :(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J HEPATOBILIARY PANCREAT SCI. 2023; 30:951¿961. HTTPS://DOI.ORG/10.1002/JHBP.1296.

    Description of Event or Problem · 0

    TITLE: CENTRAL PANCREATECTOMY PREVENTS POSTOPERATIVE DIABETES THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE SHORT- AND LONG-TERM OUTCOME OF CENTRAL PANCREATECTOMY (CP) IN COMPARISON TO DISTAL PANCREATECTOMY (DP). BETWEEN OCTOBER 2001 AND JUNE 2020, 107 PATIENTS WHO UNDERWENT OPEN CP WERE COMPARED TO 107 PATIENTS WHO UNDERWENT OPEN DP. THERE WERE 91 MEN (42.5%) AND 123 WOMEN (57.5%) INCLUDED IN THIS STUDY. OF ALL PATIENTS, THE MEDIAN AGE WAS 54.9 (IQR: 43.9¿65.8) YEARS, MEDIAN BMI WAS 24.3 (IQR: 22.2¿26.9) KG/M2, AND ASA SCORES WERE 16 ASA I (7.5%), 160 ASA II (74.8%), AND 38 ASA III (17.8%). DURING SURGERY OF CP GROUP, THE DISTAL STUMP WAS FURTHER MOBILIZED FROM THE SPLENIC VEIN AND ARTERY AND RECONSTRUCTED VIA THE ROUX-Y-RECONSTRUCTION METHOD, USING A TRANSMESOCOLIC RELOCATED JEJUNAL LOOP TO PERFORM A DOUBLE-LAYER INTERRUPTED STICH END-TO-SIDE PANCREATOJEJUNOSTOMY WITH ABSORBABLE MONOFILAMENT SUTURES (PDS 5¿0) ACCORDING TO HOSPITAL STANDARDS. RECONSTRUCTION WAS COMPLETED BY AN END-TO-SIDE ROUX-Y ENTEROENTEROSTOMY 20 TO 25 CM DISTAL TO THE LIGAMENT OF TREITZ. MEDIAN FOLLOW-UP WAS 103 (IQR 46¿166) MONTHS IN THE CP COHORT AND 90 (IQR 55¿130) MONTHS IN THE DP COHORT (P = .3329). REPORTED COMPLICATIONS INCLUDE IN-HOSPITAL MORTALITY (N=2), DEATH DURING FOLLOW-UP (N=12), POSTOPERATIVE PANCREATIC FISTULA GRADE B/C (N=31), PERIPANCREATIC FLUID COLLECTION (N=32), INTRAABDOMINAL ABSCESS (N=5), POSTPANCREATECTOMY HEMORRHAGE (N=10), DELAYED GASTRIC EMPTYING GRADE B/C (N=3), CHYLE LEAK (N=2), WOUND INFECTION (N=7), ACUTE POSTOPERATIVE PANCREATITIS (N=2), BILIARY LEAK (N=1), AN UNKNOWN EVENT REQUIRING ADDITIONAL PANCREAS RESECTION (N=4), AND ANASTOMOSIS STENOSIS (N=1). IN CONCLUSION, CP OFFERS AN IMPROVED ENDOCRINE LONG-TERM OUTCOME AT THE EXPENSE OF A HIGHER RISK OF PPH WITHOUT INCREASED PERIOPERATIVE MORTALITY. AS EVIDENCE ON THIS PARENCHYMA SPARING SURGICAL TECHNIQUE IS SPARSE, MORE PROSPECTIVE DATA ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042692 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention