MAUDE Adverse Event Report: ETHICON INC. INTERCEED (TC7) UNKNOWN PRODUCT; BARRIER, ABSORBABLE, ADHESION

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Title: effectiveness of barrier agents for preventing postoperative bowel obstruction after laparoscopic surgery: a retrospective cohort study.This study was conducted to assess the incidence of bowel obstruction after laparoscopic surgery and to compare the effectiveness of an anti-adhesion barrier in laparoscopic surgery.We compared the outcomes of patients exposed to anti-adhesion agents (barrier group) with those of patients not exposed (no barrier group) in laparoscopic surgery.Using a nationwide claim-based database in japan, we analyzed data from patients who underwent laparoscopic surgery between 2005 and 2019 and compared the patient characteristics and the proportion of those with bowel obstruction between the barrier and no barrier groups.We also performed several sensitivity and subgroup analyses.Of the 57,499 patients who met the inclusion criteria, 14,360 and 43,139 were assigned to the barrier and no barrier groups, respectively.The proportion of patients with a bowel obstruction in the two groups did not differ among all patients hospitalized for obstruction (1.1 vs.1.1%, p = 0.63) and those requiring surgery (0.2 vs.0.2%, p = 0.39).In the sensitivity analysis with propensity score matching, the incidences of bowel obstruction between the barrier and non-barrier groups were equivocal (1.3 vs.1.6%), but statistically marginal (chi-square test, p = 0.035; log-rank test, p = 0.09).Baseline demographics included age, sex, the type of barrier agent, anatomical site, the type of surgery, and the follow-up period.Since the claim codes for anti-adhesion barrier agents (hyaluronate carboxymethyl cellulose (seprafilm®) and oxidized regenerated cellulose (interceed®) were similar, we distinguished barrier agents by their sizes.Reported complication included bowel obstruction between both with barrier and no barrier groups.The use of barrier agents for adhesive prevention did not show clear effectiveness for the prevention of bowel obstruction after laparoscopic surgery for unselected cases.Further studies focusing on more specific procedures are needed.

Manufacturer Narrative

(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.The following information was requested, but unavailable: 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: surgery today.(2021) 51:1335¿1342.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17772931
• MDR Text Key: 323717126
• Report Number: 2210968-2023-06847
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P880047
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/19/2023
• 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