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 Dysphagia/ Odynophagia (1815); Insufficient Information (4580)

Event Date 06/01/2021

Event Type  Injury  

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 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? 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.Citation: laryngoscope 00: 2021 kou et al.: cold steel versus laser for repair of type 1 ltec.Https://doi.Org/10.1002/lary.29684.

Event Description

Title: endoscopic repair of type 1 laryngeal clefts and deep interarytenoid notches: cold steel versus laser.This study aims to compare cold steel and laser techniques and to assess the differences in closure rates at postoperative evaluation.Between january 2010 and december 2019, all patients diagnosed with a type 1 laryngeal clefts (t1lcs) or deep interarytenoid notches (dins) who underwent endoscopic repair were identified.A total of 180 were included in the final analysis.Of these, 127 , 72 males age at surgery 3.26 [1.79, 6.26 years ] , had cold steel repair and 53, 38 males age at surgery 2.91 [1.83, 5.91], had laser repair.Microscopic repair with cold steel is carried in suspension under spontaneous ventilation.Interarytenoid mucosa is removed using microlaryngeal instrumentation, taking care to remove all mucosa down to the apex.One to three polydioxanone (pds®, ethicon us) sutures are placed using a mass closure technique to bring the raw surfaces into opposition.Division of the aryepiglottic folds is then performed to limit postoperative obstruction.Endoscopic repair with the co2 laser is performed similarly, with the only difference being the use of the co2 laser on ultra-pulse mode through a micromanipulator on the microscope to denude the interarytenoid mucosa.Reported complications included: (n=14) breakdown of repair.Of these, 10 were seen on initial postoperative evaluation.In the cold steel group, 4 of 127 had breakdown and in the laser group, and 10 of 53 had breakdown.Revision was recommended for 13 of 14 patients with breakdown and 12 of these patients underwent revision repair.The one patient who did not choose to undergo re-repair continued to have swallowing dysfunction, but parents chose to delay re-repair due to the covid-19 pandemic.At the time of data analysis, there were three patients who did not have intact repairs, all in the laser group.One patient had symptomatic improvement so the decision was made to continue observation, another was the patient mentioned earlier who was delayed due to covid-19.The third patient underwent revision with the laser but was again noted to have breakdown of his cleft afterward.He was slightly improved but his subsequent revision has been delayed due to the covid-19 pandemic.It was concluded , that endoscopic cleft repair is a well-described and effective method for repair of type 1 laryngeal clefts (t1lcs) and deep interarytenoid notches (dins).Both cold steel and laser have high success rates; however, higher failure rates were noted in the laser repair group.Failure after laser repair may occur earlier than failure after cold steel repair.But this did not reach significance.

• 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: 15680738
• MDR Text Key: 302493217
• Report Number: 2210968-2022-08844
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/27/2022
• 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