MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

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

Patient Problem Insufficient Information (4580)

Event Date 06/23/2023

Event Type  Injury  

Event Description

Title: gluteal propeller perforator flaps: a paradigm shift in abdominoperineal amputation reconstruction the aim of the study is to present and discuss our experience in aap reconstruction using gluteal-artery-based propeller perforator flaps (g-ppf) in a case series.We report our experience in 20 patients with 23 g-ppfs after an apa, between january 2017 and march 202.Two types of perforator flaps were performed: the superior gluteal artery perforator (sgap) and the inferior gluteal artery perforator (igap) flaps.The intra-abdominal approach following apa was performed by laparotomy (n = 9, 45%), laparoscopy (n = 5, 25%), and robot-assisted surgery (n = 6, 30%).The flap skin edges were sutured with loose half-buried horizontal mattress sutures (3/0 ethilon, ethicon, inc., raritan, nj, usa) to anticipate the flap edema formation within the first 24¿72 h; indeed, tight sutures can be responsible for propeller flap suffering.The donor site was closed primarily in three planes with interrupted absorbable sutures monocryl (ethicon) and a running suture monocryl (ethicon) over suction drains.The reported complications included: - a 64-year-old male, (n=1) mild venous congestion, treatment: leech therapy in conclusion, this study allows us sharing our experience in covering perineal defects with two types of local pedicled perforator flaps based on the gluteal artery.Following the trends in plastic surgery, which tend to minimize donor site morbidity and avoid muscle harvesting, we believe the sgap and igap flaps provide great results.We propose using these robust and reliable flaps as a challenging alternative to abdominal flaps and to keep using muscular flaps for rare cases of major complications or highly complex patients.

Manufacturer Narrative

Product complaint # (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.H6 component code: g07002 ¿ device not returned related events captured via 2210968-2024-04402, 2210968-2024-04403, 2210968-2024-04404, 2210968-2024-04405, 2210968-2024-04406, 2210968-2024-04407 citation: https://doi.Org/10.3390/jcm12124014.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 19124072
• MDR Text Key: 340352751
• Report Number: 2210968-2024-04406
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K946173
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• 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: 04/03/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Male