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); Respiratory Tract Infection (2420)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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? 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.(b)(4)¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation cite: irish journal of medical science (1971 -) (2021) 190:297¿305 https://doi.Org/10.1007/s11845-020-02321-4.

Event Description

Title: modern oncological and operative outcomes in oesophageal cancer: the st.James¿s hospital experience.Patients undergoing oesophageal resection between january 2009 and december 2018 at st.James¿s hospital, the designated national center for oesophageal and gastric cancer in ireland, were prospectively studied.The standard protocol on the day of surgery includes a thoracic epidural in all patients, combined with patient controlled analgesia, and i.V.Paracetamol.Relative intraoperative fluid restriction is the standard of care, approximately 500 ml/h.All anastomoses are sutured using a standardized approach with one layer of interrupted 3.0 pds (polydioxanone) sutures (ethicon, johnson & johnson, dublin, ireland).Patients are extubated immediately after surgery and managed in a high dependency unit or intensive care unit (hdu/icu) for a minimum of 24 h before transfer to a specialist surgical ward.Reported complications included anastomotic leak (n=20),gastric conduit necrosis (n=6) , chyle leak (n=25), respiratory infection (n=98).In conclusion consistent with registry data on population survival for oesophageal cancer, this study highlights markedly improved survival outcomes in patients treated curatively, reflecting international trends, as well as low mortality rates; however, cardiorespiratory complications remain significant.

• 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: 12810699
• MDR Text Key: 280759150
• Report Number: 2210968-2021-11414
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• 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
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• 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