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 Necrosis (1971); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 12/22/2020

Event Type  Injury  

Event Description

It was reported in a journal article with title: setting up a new microsurgical breast service in a non-tertiary hospital: is it safe, and do outcomes compare to centres of excellence? the aim of the study was to show how a new microsurgical service could be established in a non-major teaching hospital and to compare our outcomes to microsurgical centers that employ an enhanced recovery protocol.From july 2018-july 2020, a total of 40 patients undergoing deep inferior epigastric perforator (diep) reconstruction were included.Of these, 70% were immediate, mean age was 49 years (27¿68) and bmi was 28.1 kg/m2 (22¿32.5).In all, 50% had one or more co-morbidities other than breast cancer.All flaps were performed by a single team consisting of the senior author and a plastic surgery trainee/resident (grade st3-st8).The diep flap was harvested using the sos technique.All flaps were based on a single perforator, identified from preoperative ct angiography, with no muscle sacrifice (ms-3).No contralateral surgery was performed concomitantly.Donor closure was performed by central undermining of the abdominal flap, with excision of the sub-scarpa fat.A vicryl mesh (ethicon, inc., somerville, nj) was placed retrorectus followed by rectus fascia closure.Progressive tension sutures of the abdominal flap were performed and no abdominal drains were employed.Wounds were dressed using the dermabond, prineo skin closure system (ethicon, inc., somerville, nj).Reported postoperative complications included n=3 flap salvage, n=4 wound infection, n=6 mastectomy necrosis, n=6 fat necrosis, n=7 clavien-dindo i complications, n=2 clavien-dindo ii complications and n=12 clavien dindo iiib complications.In conclusion, using an enhanced recovery protocol and careful patient selection can achieve surgical- and patient-reported outcomes comparable with international high volume centers almost immediately.

Manufacturer Narrative

(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: https://doi.Org/10.1016/j.Bjps.2020.12.095.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 products (vicryl mesh and prineo skin closure system) 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 products involved? patient demographics? event related to prineo skin closure system product reported via mw # 2210968-2021-12750.Event related to vicryl mesh product reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/22/2021.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, 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.Additional information was requested and the following was obtained: 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 products (vicryl mesh and prineo skin closure system) 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 products involved? patient demographics? could you please email my consultant mr will holmes at (b)(6) with your queries please?.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 01/27/2022.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, 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.

• 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: 13052810
• MDR Text Key: 288280268
• Report Number: 2210968-2021-12751
• 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,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention