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

Catalog Number ERXXX

Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994)

Event Date 07/03/2023

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 caused or contributed to the patient complications mentioned in the article? if yes, please explain.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: peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial.Author(s):(b)(6).Citation: surgical endoscopy, https://doi.Org/10.1007/s00464-023-10232-5.This study investigated whether peroperative administration of tranexamic acid (txa) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy.On (b)(6) 2021, 101 patients undergoing primary sleeve gastrectomy in a high-volume (b)(6) hospital were included in the study.The patients were randomized (1:1) to receive 1500-mg tranexamic acid or placebo peroperatively.There were 49 patients who received tranexamic acid and 52 patients who received placebo.In the tranexamic group there were 38 females and 11 males with a mean age of 36 years.In the placebo group there were 42 females and 10 males with a mean age of 36.8 years.In all patients, the same staple devices, echelon flex¿ gst (ethicon endo-surgery) to dissect the stomach and energy device, harmonic (ethicon endo-surgery), were used, starting always with a golden cartridge (3.0 mm), followed by blue (2.4 mm).The intervention group received a single dose of 1500 mg tranexamic acid (cyklokapron) during the induction of the procedure.Tranexamic acid was administered intravenously, dissolved in 100-ml sodium chloride (nacl) 0.9% in a time frame of 15¿30 min, with a maximum of 100 mg/min.The control group received a placebo during the induction of the procedure.The placebo infusion contained 100-ml nacl 0.9%, which was administered similarly.If blood pumped out of the staple line (active bleeding occurred in 77 patients), hemostatic clips (ligaclip, ethicon endo-surgery) were applied.If blood was only oozing (passive bleeding occurred in 42 patients), fibrin sealant was applied.The abdomen was inspected on day 1 and 1 week after surgery for abdominal wall hematoma.Reported complications included iatrogenic injury (n=2), active bleeding at the staple line (n=77), passive bleeding at the staple line (n=42), infected hematoma originating from a staple line bleeding (n=1), hematemesis (n=1), melena (n=1), pain (n=2), decreased hemoglobin with the presence of clinical symptoms of hemorrhage such as lightheaded, fainting, tachycardia (n=2).In conclusion, this study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of tranexamic acid.However, tranexamic acid seems to have positive effects on clinical parameters, minor complications, and length of hospital stay in patients undergoing sleeve gastrectomy, without increasing the risk of venous thrombotic event.Larger studies are needed to investigate the effect of tranexamic acid on postoperative major complications.

• 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: 17844603
• MDR Text Key: 324603658
• Report Number: 3005075853-2023-07017
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K864102
• 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: ERXXX
• 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