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 Unspecified Infection (1930); Obstruction/Occlusion (2422)

Event Date 01/18/2022

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).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: scientific reports | (2022) 12:916 |.Https://doi.Org/10.1038/s41598-022-05016-1.

Event Description

Title: effectiveness of negative pressure wound therapy with instillation and dwelling after stoma closure: a retrospective and propensityscore matching analysis.This study aims to compare the short-term outcomes between conventional primary suture closure and negative pressure wound therapy with instillation and dwelling (npwti-d) therapy with purse-string suturing using propensity score matching analysis.From january 2016 to october 2020, a total of 107 patients underwent surgery for stoma closure in our hospital.Patients were divided into two groups according to operative management.From january 2016 to november 2018, all skin wounds were closed by conventional primary closure with 67 patients.From december 2018 to october 2020, all skin wounds were closed by purse-string closure and managed using negative pressure wound therapy with instillation and dwelling (npwti-d) therapy with 40 patients.103 patients were eligible for analysis: (n=63) in conventional primary closure with 45 males and 18 females age 66 (19¿87 years ) and (n=40) in negative pressure wound therapy with instillation and dwelling (npwti-d) therapy with 29 males and 11 females age 66 (19¿83 years).For the patients who underwent stoma closure by primary closure, a spindle-shaped skin incision was made in the craniocaudal direction.For the patients who were treated with negative pressure wound therapy with instillation and dwelling (npwti-d) , a round skin incision was made.In both groups, stoma reversal was performed using the same procedure.The subcutaneous tissue around the stoma was incised, and adhesions around the intestine were detached from the abdominal wall.After the intestine had been mobilised, the segment that remained outside the abdominal wall was excised.A functional end-to-end anastomosis or albert- lembert anastomosis was then created.Glove change was performed, and a new set of instruments was used after anastomosis.Interrupted sutures (0 polydioxanone, pds, ethicon, cincinnati, ohio, usa) were used for fascial closure.After confirming haemostasis, the subcutaneous tissue was washed with 1500 ml of physiological saline.In the primary closure group, the buried suture was performed with 4-0 pds (polydioxanone, pds, ethicon, cincinnati, ohio, usa).In the negative pressure wound therapy with instillation and dwelling (npwti-d) group, the skin was closed using a purse-string subcuticular continuous suture with 4-0 pds, leaving a 10¿20 mm open circular gap (fig.1a).In addition, npwti-d (v.A.C.Veraflo therapy, kci, an acelity company, san antonio, texas) was attached to the wound reported complications included: primary closure group: (n=7) developed surgical site infection (ssi) event, where 6 occured after propensity score matching.(n=1) ileus.Negative pressure wound therapy with instillation and dwelling (npwti-d) therapy group: (n=1) infection (clavien-dindo classification = grade 2).(n=2) ileus and 1 case after propensity matching.It was concluded , that negative pressure wound therapy with instillation and dwelling (npwti-d) therapy at the stoma closure site was a highly effective treatment for reducing ssi.We believe that negative pressure wound therapy with instillation and dwelling (npwti-d) therapy should always be considered at stoma closure site.Further ingenuity will be needed to shorten the length of hospital stay and the healing period of wounds.

• 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: 15682254
• MDR Text Key: 302570833
• Report Number: 2210968-2022-08851
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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): Required Intervention