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 Sepsis (2067); Insufficient Information (4580)

Event Date 03/13/2021

Event Type  Death  

Event Description

Title: minimally invasive esophagectomy the standard of care: experience from a tertiary care cancer center from india.This retrospective study aims to review the author experience in minimally invasive esophagectomy (mie) and analyze the adequacy of the procedure and its short- and long-term outcomes.From january 2010 till december 2016, 459 patients with resectable carcinoma esophagus and gastro-esophageal junction undergoing esophagectomy at basavatarakam indo american cancer hospital, a tertiary cancer care center at hyderabad, india, were reviewed.Patients (n = 459) were stratified into two groups based on the approach into minimally invasive transhiatal esophagectomy (mi-the) and minimal invasive transthoracic esophagectomy tte (mi-tte).Two hundred seventy-eight patients (278), 146 males and 132 females, age 53 (22¿82 years ) underwent transhiatal resection (mi-the), and 181, 78 males and 103 females, age 50 (22¿77 years) transthoracic resections (mi-tthe).During surgery, in minimally invasive transhiatal esophagectomy (mi-the) group after esophagectomy, a 3 to 3.5 cm wide gastric tube is created with interrupted pds 2¿0 sutures or staplers.While in minimal invasive transthoracic esophagectomy tte (mi-tte) group, a cut is made on visceral pleura covering the esophagus and lung with the harmonic scalpel (ethicon endo-surgery, india) and extended cranially and caudally in line with the esophagus.Follow-up extended from 35 to 118 months with a median of 76 months.Reported complications included: minimally invasive transhiatal esophagectomy (mi-the): (n=14) patients developed anastomotic leakage of were caused by conduit tip necrosis (=2) requiring exploration and re-anastomosis.The rest of the anastomotic leaks settled with conservative management.(n=3) out of 5 cases of conduit bleed in minimally invasive transhiatal esophagectomy (mi-the) arm required re-exploration.(n=1) chyle leak occurred which was settled with conservative management.(n=10) late anastomotic stricture rates (n=1) intestinal obstruction.(n=1) peri-fj leak.(n=17) sss.Minimal invasive transthoracic esophagectomy tte (mi-tte): (n=1) (death) there was one major bleed from a pulmonary vein in a patient from mi-tte arm, with an estimated blood loss of 3000 ml before it was converted to thoracotomy and controlled.He succumbed to refractory hypotension and disseminated intravascular coagulation and died 6 h after surgery.(n=1) death post-operative day 5 due to pyloromyotomy leak and sepsis.(n=1) tracheobronchial injuries occurred.All were identified and repaired on the table.A total of 9 patients in mi-tte arm developed anastomotic leakage of which 2 in mi-tthe arm were caused by conduit tip necrosis requiring exploration and re-anastomosis.The rest of the anastomotic leaks settled with conservative management.One of conduit bleed in mi-tte arm required re-exploration.Two patients in mi-tte had pericardial effusion.Rest of the patients were managed conservatively and recovered uneventfully.Chyle leak occurred in 2 patients in mi-tthe settled with conservative management.(n=10) late anastomotic stricture rates (n=5) sss.(n=1) intestinal obstruction.(n=5) pleural effusions.It was concluded, that minimally invasive esophagectomy either by transhiatal or transthoracic approach is feasible and can be safely accomplished with a low morbidity and mortality and with satisfactory r0 resection rates, good nodal harvest, and acceptable long-term oncological outcomes.

Manufacturer Narrative

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/death 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? 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 2210968-2022-08764.Citation: indian journal of surgical oncology.Https://doi.Org/10.1007/s13193-021-01291-y.

• 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: 15670023
• MDR Text Key: 302393913
• Report Number: 2210968-2022-08763
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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: 10/13/2022
• 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): Death; Required Intervention