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 Problem Pleural Effusion (2010)

Event Date 09/27/2019

Event Type  Injury  

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.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 author/surgeon believe that ethicon product (pds suture) involved caused and/or contributed to death case ((b)(6) years old male) described in the article? please specify.Does the author/surgeon believe that ethicon products (vicryl mesh and pds suture) involved caused and/or contributed to post-operative complications experienced by following patients: two females of (b)(6) years old, two females of (b)(6) years old, (b)(6) years old male and (b)(6) years old female described in the article? please specify.Does the author/surgeon believe there was any deficiency with the ethicon products (vicryl mesh and pds suture) used in this procedure/study? were these all 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 these events? citation cite: (ann thorac surg 2020;109:1086 94)https://doi.Org/10.1016/j.Athoracsur.2019.09.081.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Adverse events were submitted via following medwatches: (b)(6) years old female #1 - 2210968-2021-05034 and 2210968-2021-05035, (b)(6) years old female #2 - 2210968-2021-05049, (b)(6) years old female  2210968-2021-05048, (b)(6) years old male - 2210968-2021-05045, (b)(6) years old female #2  2210968-2021-05046, (b)(6) years old male - 2210968-2021-05047.

Event Description

Title: repair of adult benign tracheoesophageal fistulae with absorbable patches: single-center experience.The objective of this present study was to analyze patient's characteristics, operative details, and outcomes of these cases.The records of all patients undergoing tef repair at institution (thoracic surgery unit, padua university hospital, padua, italy) between july 2011 (date of our first reported case) to june 2018, 23 patients underwent surgical tef repair, among them, an absorbable patch for surgical repair was used in 8 cases.There were 3 male and 5 female patients with a median age of 64 years (range, 13 to 78 years).The most common comorbidities were arterial hypertension and cardiac disease in 3 patients each.The surgical approach consisted of standard posterolateral right thoracotomy in 3 patients, high posterior right thoracotomy in 2, and cervicotomy in 3.In those patients whose surgical approach was through a thoracotomy, standard double-lumen intubation was maintained during the procedure.After careful isolation of the trachea and esophagus and division of the fistulous tract, the prosthetic patch was trimmed and sutured to the membranous wall with continuous suture.In the 3 cases of cervical tef, the fistula was approached anteriorly after transection of the trachea.A cross-field endotracheal tube was inserted distally, and the diseased tracheal segment was resected circumferentially, including the orifice of the preexisting tracheostomy.The patch was sutured between the proximal and the distal posterior edges of the trachea, whereas the anterolateral edges were either reanastomosed or, in cases of larger defects, sutured to the skin to form a new tracheostomy.The prosthetic patch consisted of gore bio-a tissue reinforcement (w.L.Gore & associates, inc, newark, de) in 6 cases and in a polyglactin 910 (vicryl) knitted mesh (ethicon, somerville, nj) in 2 cases.For sewing the prosthesis to the airway defect, 4-0 polydioxanone sutures (pds; ethicon) were used in all patients.In every case, a viable muscle flap was applied to the posterior surface of the prosthesis with the double function of giving support to airway repair and separating the trachea from theesophagus.The esophageal defect was repaired with 2-layer 4-0 pds suture in 7 patients, whereas in the patient with a concurrent long-segment severe esophageal stricture, the diseased tract was excised, and left cervical esophagostomy was performed.Reported complications included (b)(6) years old female experienced pleural effusion.In conclusion repair of tracheoesophageal fistulae with synthetic prostheses is feasible and may be effective in complex cases.Further research is needed to identify the ideal prosthetic material.

• 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: 11895877
• MDR Text Key: 266416396
• Report Number: 2210968-2021-05041
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• 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: 06/15/2021
• 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
• Patient Age: 51 YR