MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Impaired Healing (2378); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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/death described in the article? 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? would the journal author / physician like to speak with ethicon medical safety and engineering via scheduled conference call regarding the product involved in this event? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-05583, 2210968-2022-05584 and 2210968-2022-05586.Citation cite: citation: orcid: https://orcid.Org/0000-0002-3122-0140.

Event Description

Title: economics and safety of continuous and interrupted suture hepaticojejunostomy: an audit of 556 surgeries.This study compares the safety, economics, short- and long-term outcomes of continuous suture hepaticojejunostomy (cshj) and interrupted suture hepaticojejunostomy (ishj).A retrospective cohort analysis involving all hjs between january 2014 and december 2018 was conducted.A total of 556 eligible patients were analyzed.Polyglactin 3-0 and 4-0(vicryl), and polydioxanone (pds, 3-0, 4-0, 5-0 ) sutures were used.Reported complications included clavien-dindo (n=364), clavien-dindo i (n=102) , clavien-dindo ii (n=14), clavien-dindo iiia (n=40), clavien-dindo iiib (n=19), clavien-dindo iva (n=1) , septic shock and death (n=16) , bile leak (n=54), surgical site infection, biliary fistula , intra-abdominal bleeding, anastomotic stricture.In conclusion long-term results, moribidity and mortality associated with cshj and ishj are similar.However, cshj is more economical and quicker, and is associated with a lower bile leak rate than ishj based on the analysis of 556 hjs, and therefore merits routine use in suitable ducts.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15041333
• MDR Text Key: 296058150
• Report Number: 2210968-2022-05585
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention