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 Problems Abdominal Pain (1685); Adhesion(s) (1695); Fever (1858); Fistula (1862); Inflammation (1932); Fluid Discharge (2686); Spontaneous Abortion (4514)

Event Type  Injury  

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.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.Please provide the patient's demographic information including weight, bmi at the time of index procedure.Date of index surgical procedure? were any concomitant procedures performed? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? was meticulous hemostasis performed prior to use of interceed? what color was the interceed prior to closure? did the interceed come in contact with heme prior to use? how was the interceed product applied? one layer? wadded? was there excessive tissue desiccation (cautery use) at the site of interceed application? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? please describe the patient manifestations of the reported infection/inflammation (severity, appearance, systemic or local infection).Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre- or intra-operation? were cultures performed? if so, please provide the results.How much and what type of drainage is present in this wound? were pre-existing adhesions noted during the procedure? how were the post-procedural adhesions confirmed? what is the location and severity of the adhesions? please describe any surgical intervention required including the date and results.Was the interceed removed? please describe any medical intervention performed including medication name and results.What is the relationship of reported event to the interceed implanted? what is the relationship of reported event to the vicryl suture used? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? product code and lot number of the interceed? product code and lot number of the vicryl suture? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.Related events captured via 2210968-2023-10318.

Event Description

It was reported by a tumor resection procedure on an unknown date and an absorbable adhesion barrier was used.At 7 weeks pregnant, the patient visited our hospital with a chief complaint of lower abdominal pain.Emergency surgery revealed tumor contents containing fat, and the patient was diagnosed with peritonitis due to rupture of a mature cystic teratoma in the left ovary.After the tumor was removed, a single ligation suture was performed and while the abdominal cavity was washed with physiological saline, the absorbable adhesions barrier was applied to the left ovary and fundus of the uterus.On the day after surgery, the patient's body temperature rose to 39 degrees, crp was 23 mg/dl, and white blood cell count was 16,910/l, indicating a high inflammatory response, so antibiotics were administered and the patient's progress was monitored.Crp and white blood cell values peaked 2 days after surgery, but peaked out on the 4th day after surgery, and the uterine contents were excreted, resulting in a complete miscarriage.Inflammation remained high until 4 days after surgery, suggesting that inflammatory adhesions developed in the left adnexa and abdominal wall, leading to ovarian cutaneous fistula.The patient was discharged from the hospital 9 days after surgery.One month after the surgery, during a follow-up outpatient visit, the patient noticed pain in the lower abdomen and the sensation of a mass.Furthermore, exudate was observed to flow from the wound, so an mri examination was performed seven months after the surgery.As a result, a fistula was suspected.One year after the initial surgery, laparoscopic ovarian incarceration release and fistula closure abdominal wall repair were performed, and the omentum and left appendage were found to have adhered to the abdominal wall.In addition, uterine tissue was concentrated in the abdominal wall wound.The incarcerated ovary within the abdominal wall was detached, the part with the skin fistula was excised by a plastic surgeon, and the wound was closed after confirming that there was no fascial rupture.There was no exudation from the wound after the surgery, and no recurrence occurred 3 months after the surgery.Additional information will be requested.

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.Additional information was requested and the following was obtained: please provide the patient's demographic information including weight, bmi at the time of index procedure: a 44-year-old pregnant woman.Date of index surgical procedure? unk.Were any concomitant procedures performed? no.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open.Was meticulous hemostasis performed prior to use of interceed? sufficient washing was performed before application of interceed.What color was the interceed prior to closure? unk.Did the interceed come in contact with heme prior to use? unk.How was the interceed product applied? one layer? wadded? one layer.Was there excessive tissue desiccation (cautery use) at the site of interceed application?no.What symptoms did the patient experience following the index surgical procedure? onset date? on the day after surgery, the patient's body temperature rose to 39 degrees, crp was 23 mg/dl, and white blood cell count was 16, 910/l, indicating a high inflammatory response, so antibiotics were administered and the patient's progress was monitored.Crp and white blood cell values peaked 2 days after surgery, but peaked out on the 4th day after surgery, and the uterine contents were excreted, resulting in a complete miscarriage.Other relevant patient history/concomitant medications? no.Please describe the patient manifestations of the reported infection/inflammation (severity, appearance, systemic or local infection).No infection.Inflammation was refer prior question.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no infection.Did the patient receive any prophylactic antibiotics pre- or intra-operation? not reported.Were cultures performed? if so, please provide the results.Several times after operation.The result was negative.How much and what type of drainage is present in this wound? the exudate was assumed to be cyst fluid.Were pre-existing adhesions noted during the procedure? yes.How were the post-procedural adhesions confirmed? reoperation.What is the location and severity of the adhesions? some part was easily detached, but other was difficult.Please describe any surgical intervention required including the date and results.1 year post-op, adhesion was confirmed.Was the interceed removed? no.Please describe any medical intervention performed including medication name and results.Unk.What is the relationship of reported event to the interceed implanted? the surgeon didn't clarify the relationship between inflammation and products.What is the relationship of reported event to the vicryl suture used? the surgeon didn't clarify the relationship between inflammation and products.What is the physician¿s opinion as to the etiology of or contributing factors to this event? inflammation caused by the rupture of the ovarian cyst had occurred before the surgery and continued until 4 days after the surgery, which is thought to have contributed to the intractable wound.What is the patient's current status? there has been no recurrence.Product code and lot number of the interceed? unk.Product code and lot number of the vicryl suture? unk.

• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18424979
• MDR Text Key: 331791927
• Report Number: 2210968-2023-10317
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/01/2024
• 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: 44 YR
• Patient Sex: Female