MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP APPLIER UNKNOWN PRODUCT; CLIP, IMPLANTABLE

Catalog Number LIGAPPUNK

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Hernia (2240); Insufficient Information (4580)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/29/2023.D4: batch # unk.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 author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article?" 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/batch number has not been provided.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, 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.

Event Description

It was reported via journal article: title: teaching microsurgical breast reconstruction ¿ a retrospective cohort study authors: sebastian fischer, yannick f.Diehm , dimitra kotsougiani-fischer, emre gazyakan, christian a.Radu, thomas kremer, christoph hirche and (b)(6).Citation: j.Clin.Med.2021, 10, 5875.Https://doi.Org/10.3390/jcm10245875.The objective of this study is to present an approach for teaching deep inferior epigastric artery perforator (diep) and transverse upper gracilis (tug) flap breast reconstruction, which can diminish complications and provide secure and satisfying outcomes from the first breast reconstruction with diep or tmg flap, respectively.Between october 2015 to september 2018, a total of 95 deep inferior epigastric artery perforator (diep) and 93 transverse upper gracilis (tug) flaps were included into this study.Before the first diep/tug flap without supervision, each trainee underwent a mean of 6.8 diep and 7.3 tug training surgeries.Diep and tug flap procedures for breast reconstruction were either performed by a senior surgeon (>200 diep/tug, ¿no-training group¿), or taught to one of five trainees (>80 breast surgeries; >50 free flaps) in a step-wise approach.The latter were either performed by the senior surgeon, and a trainee was assisting the surgery (¿passive training¿); by the trainee, and a senior surgeon was supervising (¿active training¿); or by the trainee without a senior surgeon (¿after training¿).Surgeries of each group were analyzed regarding or-time, complications, and refinement procedures.During surgery, mono- and bipolar cautery were used, and for perforator dissection and branch ligature, a ligaclip clip applier was utilized.Once the flap was elevated, the same team inset the flap and performed the arterial anastomosis with interrupted sutures (8-0 ethilon, ethicon inc., sommerville, nj, usa).A coupler device (synovis micro companies alliance inc., birmingham, al, usa) was used for venous anastomosis.Reported complications included revision (n=32), complication total (n=139), partial flap loss (n=15), complete flap loss (n=7), fat necrosis (n=25), wound dehiscence recipient site (n=6), wound dehiscence donor site (n=33), infection recipient site (n=9), infection donor site (n=16), hematoma recipient site (n=26), hematoma donor site (n=32), hernia donor site (n=3).In conclusion, the introduced stepwise training approach is a safe and effective method for teaching microsurgical breast reconstruction with means of diep and tug flaps.Importantly, prior to starting microsurgical breast reconstruction training, trainees must be confident with general breast surgery and microsurgery.Of note, number of training procedures and outcomes did not differ between perforator diep and non-perforator tug flaps, highlighting the importance of teaching flap inset at the recipient site for an appropriate outcome.

• Brand Name: LIGACLIP APPLIER UNKNOWN PRODUCT
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17844975
• MDR Text Key: 324608816
• Report Number: 3005075853-2023-07027
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LIGAPPUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention