MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pleural Effusion (2010); Pneumothorax (2012); Post Operative Wound Infection (2446)

Event Date 08/12/2022

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.Related events captured via 2210968-2023-00461 and 2210968-2023-00462 citation: https://doi.Org/10.1007/s11748-022-01862-y.

Event Description

Title: a paradigm shift for diaphragmatic and chest wall reconstruction using a bovine acellular dermal matrix: an analysis versus synthetic meshes.The aim of this study was to investigate the use of a bovine acellular dermal matrix (surgimend, integra lifesciences, princeton, nj, usa) in diaphragmatic and chest wall reconstruction by comparing it with synthetic meshes.Consecutive patients who underwent diaphragmatic and/or chest wall reconstruction at a single center from 2016 to 2021 were retrospectively reviewed.Outcome measures included surgical site complications, readmission, and reoperation.Sixty-six patients underwent diaphragmatic and/or chest wall reconstruction for a malignant (74.2%) or benign (25.8%) disease.Surgimend was used in 26 (39.4%) patients and a synthetic mesh in 40 (60.6%) patients.Polypropylene (prolene, ethicon), polyglactin 910 (vicryl mesh, ethicon) were used.Reported complications included prolonged air leak (n=6), pleural effusion (n=5), pneumothorax (n=2), empyema (n=1), wound infection (n=1), clavien-dindo grade i (n=8), clavien-dindo grade ii (n=13), clavien-dindo grade iiia (n=4), clavien-dindo grade iiib (n=5), in conclusion diaphragmatic and chest wall reconstruction with surgi- mend is associated with fewer surgical site complications, including infection, compared to synthetic meshes that have been traditionally used for this purpose.Larger studies with a longer follow-up period are needed to further define specific surgical indications and describe long-term outcomes.

• Brand Name: VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16230180
• MDR Text Key: 307982132
• Report Number: 2210968-2023-00462
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• 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: 01/16/2023
• 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