MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 24IN 1 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1A304

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Insufficient Information (4580)

Event Date 01/02/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.Component code: g07002 device not returned.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: [the patient demographics] 81 year old woman.[current status of the patient] the patient is in the hospital.[progress] the symptom has been resolving with vac therapy, and the patient seems to be able to be discharged in 1 - 2 weeks.[health injury details and treatment details] (b)(6) 2022, pd : pancreaticoduodenectomy was performed.(b)(6) 2023, inflammatory reaction was observed in the wound.It seemed to be under the skin, and the wound was slightly opened.Ssi occurred.Ascites was controlled.The patient took diuretics and antibiotics.(b)(6) 2023 the wound was opened, but the symptoms did not subside.(b)(6) 2023 upon detailed examination with ct, the subcutaneous abscess did not subside, and therefore the entire wound was opened.At the fascia under the skin, the stratafix symmetric was found to have broken at the wound margin.(b)(6) 2023 vac therapy was started.The patient took zinc.(b)(6) 2023 the symptom improved.(b)(6) 2023 the symptom got much better and seemed to be resolving in 1 -2 weeks.[product use details] it was used for pd : pancreaticoduodenectomy on (b)(6) 2022.[other contributing factor] the presence of ssi and ascites is considered to be the cause related to wound dehiscence.[medical history] the patient had no history of treatment for diabetes mellitus.The patient has a history of treatment for hypertension or hyperlipidaemia.[allergic tendency / smoking habit] none.[details and results of laboratory tests] preoperative hba1c was slightly high at 6.7.

Event Description

It was reported that a patient underwent a subtotal stomach-preserving pancreatoduodenectomy procedure on an unknown date and barbed suture was used.The suture method was continuous suture.The patient developed a severe surgical site infection.About 3 weeks after the surgery, the wound was dehiscent and it was found that the product was broken.The surgeon stated they are aware of the risk of dehiscence because of the wound ssi, but the product broke 3 weeks after surgery and the patient was a 81 year-old woman who has no strong abdominal muscles.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 2/22/2023.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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: please provide the patient's weight, bmi at the time of index procedure, 81 year old woman.The diagnosis and indication for the index surgical procedure? procedure: subtotal stomach-preserving pancreatoduodenectomy.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? unknown.What was the tissue condition (normal, thin, calcified, fragile, diseased)? not thick abdominal muscle.Was the fixation tab seated against the tissue at the initiation of suture use not thick abdominal muscle.Unknown but rep said maybe yes.Were two reverse stitches performed across the incision prior to closure? unknown but rep said maybe yes.What tissue dehisced? fascia.Where was the suture noted to be broken (termination, middle, end)? near by fixation tab.Please describe the appearance of the suture during the second and thinear by fixation tab, breakage near by fixation tab but detail was unknown.Were there any precipitating stress factors that led to the suture breaking? the surgeon think ascites fluid recognized the patient was one of the risk for dehidscence please describe any medical intervention performed including medication name and results.Diuretics and antibiotics prescribed.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? not reported.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? yes post-op.Were cultures performed? if so, please provide the results.Unknown.How much and what type of drainage is present in this wound? unknown.Were any pre-op cleansing procedures changed recently? if yes, please describe unknown.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement? not reported.Other relevant patient history/concomitant medications? hba1c was 6.7 a little bit high.She had a history of treatment for hypertension and hyperlipidemia.What is the physician¿s opinion as to the etiology of or contributing factors to the infection and ascites? hba1c was 6.7 a little bit high.She had a history of treatment for hypertension and hyperlipidemia.What is the patient's current status? recovering.Lot number? unknown.

• Brand Name: STFX SYM PDS+ UNI VIO 24IN 1 S/A CTB-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16292994
• MDR Text Key: 308738323
• Report Number: 2210968-2023-00787
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031245297
• UDI-Public: 10705031245297
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K141776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A304
• Device Catalogue Number: SXPP1A304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Female