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 Granuloma (1876)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

(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) related events reported via 2210968-2022-08796, 2210968-2022-08797, and 2210968-2022-08798 citation: laryngoscope (2022); 132:612¿618.Https://doi.Org/10.1002/lary.29799.

Event Description

Title: subglottic mucosal flap: endoscopic single-stage reconstruction for anterior glottic stenosis.The aim of this retrospective cohort study was to describe the anterior subglottic mucosal flap (asgmf), a one-stage, keel-free technique for anterior glottic stenosis (ags) repair.A total of 12 patients (9 males and 3 females; mean age of 58 [median: 63, range 29-84]) operated using the asgmf for correction or prevention of ags by a single surgeon (the first author, yonatan lahav) between 2017 and 2020 in either kaplan or assuta medical centers, israel, were included in the study.The etiologies for ags were either iatrogenic due to previous surgery at the anterior commissure, vocal fold carcinoma, dysplasia, papilloma, and congenital anomaly.During surgery, one to three endoscopic 5/0 pds (polydioxanone) sutures (ethicon© johnson & johnson medical n.V., machelen, belgium) were applied to attach the free edge of the flap to the residual mucosal lining of one (often the left) vocal fold.This allowed for vocal fold mucosal continuity at one side and, therefore, could prevent new web/stenosis formation.Mean follow-up period after surgery was 17.3 months (median: 16.2 range: 3¿44.4).Reported complications include mild anterior glottic gap (n=2); minimal improvement due to suture detachment in a relatively small web (n=1) in a 64-year-old male patient; partial flap retraction and residual web (n=1) requiring a revision surgery by a simple lysis; recurrent papillomatosis over the reconstructed commissure 3 months after surgery (n=1) in a 38-year-old male patient; small temporary contact granulation on the right vocal process post-operatively (n=1) in a 62-year-old male patient.In conclusion, asgmf is a reliable, durable, and repeatable technique for reconstruction of stenotic anterior commissure in a one-stage, stent-free endoscopic procedure that allows for significant geometric and functional restoration of the anterior commissure.

• 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: 15676936
• MDR Text Key: 302470583
• Report Number: 2210968-2022-08795
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 10/26/2022

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: 10/26/2022
• 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): Other
• Patient Age: 62 YR
• Patient Sex: Male