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 Fever (1858); Hemorrhage/Bleeding (1888); Pain (1994); Pleural Effusion (2010); Pneumonia (2011); Pneumothorax (2012); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: the annals of thoracic surgery (2021), doi: https://doi.Org/10.1016/j.Athoracsur.2020.11.012.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (vicryl mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved?.

Event Description

It was reported in a journal article with title: vicryl mesh coverage reduced recurrence following bullectomy for primary spontaneous pneumothorax.The aim of this two-center, single-blind, parallel-group, prospective, randomized controlled trial is to investigate whether using a vicryl mesh, which covers the staple line after bullectomy, reduces the postoperative-recurrence rate.Between june 2013 to march 2016, a total of 204 patients (aged 15¿50 years) who required surgical intervention because of ipsilateral pneumothorax recurrence, continuous air leaks lasting 3 or more days, contralateral pneumothorax recurrence, or an uncomplicated first episode of pneumothorax were included in the study.On the day of surgery, patients were randomly assigned (1:1) to receive vicryl mesh (mesh group) or not (control group) after thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion.In 102 patients (89 were male; mean age = 21.6±6.4 years; mean height = 173.5±7.8 cm; mean weight = 58.2±9.7 kg; mean bmi = 19.3±2.4) who were assigned to the mesh group, a woven absorbable mesh (vicryl mesh 30 cm × 30 cm; ethicon) was used and trimmed to 1/2 to 1/3 of its original size as needed, according to the area of the patient¿s thoracic cavity.The other 102 patients were assigned to the control group.The mean follow-up duration was 26.2±11.3 months (range 14¿47 months).Reported complications included pneumothorax recurrence (n=5) which required observation in 2 patients, while 3 patients underwent closed thoracostomy, pain (n=?), air leaks > 3 days (n=3), fever 38° c (n=16), hemothorax (n=1), pneumonia (n=1).In conclusion, this study demonstrated that the use of vicryl mesh to cover the staple line can effectively reduce postoperative recurrence in patients with psp undergoing thoracoscopic bullectomy and mechanical pleurodesis.The vicryl mesh coverage method can be considered an ideal adjunct to the standard surgical procedure for psp.

• 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.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12021958
• MDR Text Key: 267558627
• Report Number: 2210968-2021-05655
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K810428
• 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
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• 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