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 Failure to Anastomose (1028); Necrosis (1971); Nerve Damage (1979); Paresis (1998); Pleural Effusion (2010); Sepsis (2067); Obstruction/Occlusion (2422); Respiratory Failure (2484)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Title: comparison of esophagectomy outcomes between a national center, a national audit collaborative, and an international database using the esophageal complications consensus group (eccg) standardized definitions patients undergoing esophageal resection atst.James¿s hospital, dublin, the designated irish national esophageal and gastric center (inc) between january 2014 and december 2018,were prospectively studied.Most surgery was an open en bloc esophagectomy including a right thoracotomy, with intrathoracic or cervical anastomosis.The standard protocol includes a thoracic epidural, and relative intraoperative fluid restriction, at approximately 500 ml/hour.All intrathoracic and cervical anastomoses are sutured using a standardized approach with one layer of interrupted 3.0 pds (polydioxanone) sutures (ethicon, johnson & johnson, dublin).Patients are extubated immediately after surgery and managed in icu for a minimum of 24 hours before transfer to a specialist surgical ward.Reported complications included anastomotic leak, conduit necrosis, chyle leak, delayed gastric emptying, acute respiratory distress syndrome (ards), pleural effusions,sepsis, nerve injury, clavien dindo grade iii and iiib and ileus.In conclusion the study highlights the value of the eccg definitions and esodata project for comparative analysis, and the clear potential to use the large contemporaneous eccg dataset to enable audit and quality improvement at institution, national, and international level.It also creates an opportunity to increase knowledge and to improve standards through research of key modifiable complications, in particular, anastomotic leaks and pneumonia.

Manufacturer Narrative

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.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products (pds suture) involved caused and/or contributed to death in one patient due to acute respiratory distress syndrome (ards)? please specify.Does the surgeon believe that ethicon products (pds suture) involved caused and/or contributed to post-op complications for non-death cases (clavien-dindo grade iii and iiib; anastomotic leak, conduit necrosis, chyle leak, delayed gastric emptying, acute respiratory distress syndrome (ards), pleural effusions, sepsis, nerve injury and ileus) described in the article? please specify.Does the surgeon believe there was any deficiency with the ethicon products (pds suture) used for all cases in this study? if yes, please provide patient demographics for death case due to acute respiratory distress syndrome (ards) and non-death cases with post-op complications (clavien-dindo grade iii and iiib; anastomotic leak, conduit necrosis, chyle leak, delayed gastric emptying, acute respiratory distress syndrome (ards), pleural effusions, sepsis, nerve injury and ileus)? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Would the author/surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the products involved in death case due to acute respiratory distress syndrome (ards)? has an autopsy been performed for this one death case (patient died due to acute respiratory distress syndrome) ? if so, can the results be shared? citation cite: diseases of the esophagus (2021)34,1¿9.Doi: 10.1093/dote/doaa060.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-11105.

Manufacturer Narrative

Product complaint #(b)(4).Additional information: h6: f07: chyle leak.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, or its employees that the report constitutes an admission that the product, ethicon, 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.

• 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
• MDR Report Key: 12778602
• MDR Text Key: 285534168
• Report Number: 2210968-2021-11103
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention