MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 24IN 0 S/A CTX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1A442

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

Patient Problem Adhesion(s) (1695)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? were any concomitant procedures performed? the diagnosis and indication for the index surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? were pre-existing adhesions noted during the procedure? how were the post-procedural adhesions confirmed? location and severity of adhesions? please describe any surgical intervention required including the date and results.The relationship of adhesions to stratafix used? please provide more detail on why the surgeon believes the barbs were the cause of the small bowel adhesion.What is the patient¿s current status? product lot number? are any photos available? 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.(b)(4).Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.

Event Description

It was reported that a patient underwent an exploratory laparotomy on (b)(6) 2021 and suture was used.A month later, the patient returned for an ex-lap/bowel resection and a small bowel adhesion was found.The physician opined the barbs were the cause of the small bowel adhesion which resulted in the surgery.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to fda: 07/12/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure not known.Date and name of index surgical procedure? ex-lap and roughly a month before (b)(6) 2021.Were any concomitant procedures performed? this procedure was a month after a previous ex lap, no further surgeries known.The diagnosis and indication for the index surgical procedure? ex lap, small bowel resection.Looked as though the barbs had cause the adhesion.What were current symptoms following the index surgical procedure? onset date? a month after first surgery, abdominal pain and gi issues.Other relevant patient history/concomitant medications? was stated that she wasn¿t a very healthy person.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? initial approach was open each time.Were pre-existing adhesions noted during the procedure? no pre-existing adhesions noted.Adhesions were located on the previous open incision area where symmetric was used to close.How were the post-procedural adhesions confirmed? ex-lap was performed and the doctor stated the bowel looked as thought it was adhered tot he incision area and looked as thought the barb were attached tot he small bowel.Location and severity of adhesions? midline incision, severe please describe any surgical intervention required including the date and results.Ex-lap was the only surgical intervention noted the relationship of adhesions to stratafix used? doctor stated when the patient was opened it look like the barbs of symmetric had got caught in the small bowel causing it to adhere and cause adhesions.Please provide more detail on why the surgeon believes the barbs were the cause of the small bowel adhesion.During surgery, when taking down the adhesions, he noticed the barb looked like they had got caught in the barbs.What is the patient¿s current status? not known.Product lot number? not known.Are any photos available? no.

• Brand Name: STFX SYM PDS+ UNI VIO 24IN 0 S/A CTX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11979230
• MDR Text Key: 267272817
• Report Number: 2210968-2021-05435
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031244979
• UDI-Public: 10705031244979
• Combination Product (y/n): Y
• PMA/PMN Number: K141776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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
• Device Model Number: SXPP1A442
• Device Catalogue Number: SXPP1A442
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 07/02/2021
• Supplement Dates FDA Received: 07/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention