BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 8693050 · Received June 12, 2019

    Report

    Report Number
    2210968-2019-82683
    Event Type
    Injury
    Date Received
    June 12, 2019
    Report Date
    May 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 07/12/2019. CORRECTED INFORMATION: ADVERSE EVENT OR PRODUCT PROBLEM, OUTCOMES ATTRIBUTED TO ADVERSE EVENT, TYPE OF REPORTABLE EVENT¿ 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: THE CASES DISCUSSED IN THIS ARTICLE WERE NEVER REPORTED TO ETHICON. WE DON¿T SUPPOSE THAT ETHICON PRODUCTS CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS DESCRIBED. THERE WAS NO DEFICIENCY WITH ETHICON PRODUCTS USED IN THIS PROCEDURES.

    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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PDS II OR STRATAFIX UNIDIRECTIONAL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PDS II OR STRATAFIX UNIDIRECTIONAL SUTURE) USED IN THIS PROCEDURE? CITATION: UPDATES IN SURGERY. DOI: HTTPS://DOI.ORG/10.1007/S13304-018-0589-2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: BARBED VS CONVENTIONAL SUTURES IN BARIATRIC SURGERY: A PROPENSITY SCORE ANALYSIS FROM A HIGH-VOLUME CENTER". AUTHOR/S: FRANCESCO PENNESTRÌ, PIERPAOLO GALLUCCI, FRANCESCA PRIOLI, PIERO GIUSTACCHINI, LUIGI CICCORITTI, LUCA SESSA, ROCCO BELLANTONE, MARCO RAFFAELLI. CITATION: UPDATES IN SURGERY. DOI: HTTPS://DOI.ORG/10.1007/S13304-018-0589-2. THE AIM OF THIS STUDY IS TO ASSESS SAFETY AND EFFICACY OF BARBED SUTURES COMPARED TO CONVENTIONAL SUTURES TO CLOSE THE GASTRIC POUCH¿JEJUNAL ANASTOMOSIS (GPJA) IN PATIENTS UNDERGOING ROUX-EN-Y (RYGB) AND ONE-ANASTOMOSIS (OAGB) GASTRIC BYPASSES, BY EVALUATING THE IMPACT OF THE PROCEDURE ON OPERATIVE TIME AND RELATED POST-OPERATIVE COMPLICATIONS, USING PROPENSITY SCORE-MATCHING (PSM) ANALYSIS TO REDUCE SAMPLE SELECTION BIAS. A RETROSPECTIVE REVIEW OF 488 PATIENTS WHO UNDERWENT PRIMARY BARIATRIC SURGERY, BETWEEN JANUARY 2012 AND DECEMBER 2017 AT THE FOUNDATION GEMELLI HOSPITAL, CATHOLIC UNIVERSITY OF THE SACRED HEART. PATIENTS WERE DIVIDED INTO TWO DIFFERENT GROUPS (RYGB-G AND OAGB-G). IN RYGB GROUP, MONOFILAMENT ABSORBABLE 3/0 PDS (CONVENTIONAL SUTURE [CS]; ETHICON) WAS ROUTINELY USED IN 244 PATIENTS (65 MALE AND 179 FEMALE; AGE RANGE: 35-49 YEARS; BMI: 40.3-47.3 KG/M2) UNTIL DECEMBER 2014, AND STRATAFIX 2/0 MONOFILAMENT UNIDIRECTIONAL BARBED ABSORBABLE SUTURE (BARBED SUTURE [BS]; ETHICON) WAS USED IN 244 PATIENTS (62 MALE AND 182 FEMALE; AGE RANGE: 35-50 YEARS; BMI: 40.5-47.4 KG/M2) FROM JANUARY 2015 TO DECEMBER 2017. A SIDE-TO SIDE JEJUNOJEJUNAL ANASTOMOSIS WAS CREATED WITH ECHELON FLEX POWERED 60 MM INTRODUCED FOR ONLY 35 MM, BLUE CARTRIDGE 3.5 MM SIZE LINEAR STAPLER (ETHICON). A DOUBLE LAYER MONOFILAMENT ABSORBABLE 3/0 PDS (ETHICON) RUNNING SUTURE WAS PERFORMED TO CLOSE THE ENTEROTOMIES OF THIS ANASTOMOSIS. IN OAGB GROUP, MONOFILAMENT ABSORBABLE 3/0 PDS (CONVENTIONAL SUTURE [CS]; ETHICON) WAS ROUTINELY USED IN 24 PATIENTS (7 MALE AND 17 FEMALE; AGE RANGE: 35.25-47.75 YEARS; BMI: 42.1-50.7 KG/M2) UNTIL DECEMBER 2014, AND STRATAFIX 2/0 MONOFILAMENT UNIDIRECTIONAL BARBED ABSORBABLE SUTURE (BARBED SUTURE [BS]; ETHICON) WAS USED IN 24 PATIENTS (8 MALE AND 16 FEMALE; AGE RANGE: 35.25-53.50 YEARS; BMI: 42.3-52.2 KG/M2) FROM JANUARY 2015 TO DECEMBER 2017. REPORTED COMPLICATIONS IN THE RYGB GROUP INCLUDED GPJA LEAKAGE (N-2 IN CS) AND JEJUNOJEJUNAL ANASTOMOSIS LEAKAGE (N-1 IN CS, N-1 IN BS) IN WHICH FURTHER LAPAROSCOPIC SURGERY WAS NEEDED IN ALL OF THESE CASES TO PERFORM A NEW ANASTOMOSIS, JEJUNOJEJUNAL ANASTOMOSIS STENOSIS (N-1 IN CS, N-2 IN BS) INTRALUMINAL BLEEDING (N-1 IN CS, N-2 IN BS), EXTRALUMINAL BLEEDING (N-1 IN CS, N-1 IN BS), AND TROCAR SITE HERNIA (N-1 IN CS) WHICH REQUIRED URGENT SURGICAL REVISION. IN OAGB GROUP, EXTRALUMINAL BLEEDING (N-1 IN CS). IN CONCLUSION, THE STUDY SUPPORTS THE USE OF BARBED SUTURES TO CLOSE THE ENTEROTOMIES OF GPJA AS A SAFE AND EFFECTIVE TECHNIQUE THAT MAY BE COMPARABLE TO THE CONVENTIONAL SUTURES FOR OPERATIVE TIME, POST-OPERATIVE COMPLICATIONS, AND HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483607 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention