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 Pneumonia (2011); Sepsis (2067)

Event Date 12/29/2020

Event Type  Death  

Event Description

Title: the multidisciplinary management of recurrent tracheoesophageal fistula after esophageal atresia: experience with 135 cases from a tertiary center.This retrospective study aims to report a retrospective seven-year review of our experience in the management of recurrent tracheoesophageal fistula (rtef), and compare the clinical outcomes before and after the application of the multidisciplinary (mdt) approach.Between june 2012 and december 2019, 135 patients with recurrent tracheoesophageal fistula (rtef) were treated at the department of pediatric general surgery, xin- hua hospital of shanghai jiao tong university school of medicine, shanghai, china.All patients included in the studies had recurrent tracheoesophageal fistula (rtef) after repair of esophageal atresia and tracheoesophageal fistula (eatef).All patients were divided into two groups based on the different strategies adopted in the treatment: the pre-multidisciplinary (mdt) group ( n = 35) with 22 males with gestational age 39.0 (34.0¿41.0 weeks ) and age at recurrent tracheoesophageal fistula (rtef) repair 7.5 (2.4¿45.6 months) and the post-multidisciplinary (mdt) group ( n = 100) with 67 males with gestational age 39.1 (31.0¿41.4 weeks) and age at recurrent tracheoesophageal fistula (rtef) repair 7.7 (2.3¿59.7 months).During surgical repair of recurrent tracheoesophageal fistula (rtef),for the patients who had multi-site fistulas and had undergone more than three operations for tef, an esophageal replacement was considered.We used 5¿0 absorbable monofilament sutures (pds-ii, ethicon ) for esophageal/tracheal repair to minimize inflammation and foreign body reactions.The median follow-up was 25.8 months (range, 6.0¿84.5 months).Reported complications included: (n=25) had anastomotic stenosis (as), and all of them were cured by serial balloon dilation.(n=24) developed anastomotic leak (al), and 26 of these cases were resolved by conservative treatment, while two other patients underwent a second reoperation and had an uneventful recovery.(n=8) second recurrence of the repaired tracheoesophageal fistula (tef) was noted.Among them, we identified anastomotic leak (al).In 10 patients before the development of the second recurrence of tracheoesophageal fistula (tef).The remaining two patients with a second recurrence of tef had an uneventful recovery without anastomotic leak (al) and anastomotic- stenosis (as) after original surgical repair for recurrent tracheoesophageal fistula (rtef).Except for the one who refused reoperation, the remaining 11 patients with second recurrence of tracheoesophageal fistula (tef) received reoperations, and eight of them were cured.(n=3) developed a third recur- recurrence of tracheoesophageal fistula (tef).Esophageal replacement (colonic interposition) was performed in one patient at six months after the second reoperation- and led to a satisfied outcome.One patient was cured by a third revisional surgical repair for tracheoesophageal fistula (tef).The remaining patient had a fourth recurrence of tracheoesophageal fistula (tef) combined with multiple esophageal-right upper bronchus fistulas, and segmental resection of esophagus and partial right upper lobectomy were performed successfully to close the tracheoesophageal fistula (tef).(n=4) subglottic stenosis with weaning failure.Granulation formation in the vocal cord and the subglottic area was identified by laryngoscopy and all were cured by endoscopic therapy.(n=2) tracheal stenosis and granulation formation was found at the distal end of the endotracheal tube and was removed under rigid bronchoscopy.(n=1) the patient had weaning failure, and bronchoscopy revealed lower tracheal stenosis caused by granulation tissue.The parents decided to transfer the patient to another hospital, and the patient died from severe pneumonia and septicemia after endoscopic tracheal stent therapy.(n=23) pathological gastroesophageal reflux (ger).Endoscopic evaluation was recommended, but it was only performed in two patients and confirmed gastroesophageal reflux (ger).With esophagitis.Eighteen of them were relieved by conservative treatment.The remaining five patients underwent nissen fundoplication, and none of them experienced dysphagia or vomiting after fundoplication.It was concluded ,that the multidisciplinary- (mdt) approach by fostering coordination of surgical, medical, radiological, and nutritional management is beneficial in the management of recurrent tracheoesophageal fistula (rtef) and leads to a satisfactory outcome.

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 2210968-2022-08757.Citation: journal of pediatric surgery 56 (2021) 1918¿1925.Https://doi.Org/10.1016/j.Jpedsurg.2020.12.019.

• 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: 15670461
• MDR Text Key: 302394164
• Report Number: 2210968-2022-08758
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 11/03/2022

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2022
• 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): Required Intervention; Death