MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A301

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

Patient Problems Scar Tissue (2060); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2020

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.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).Additional information was requested and the following was obtained: procedure date: (b)(6) 2020.Event date (b)(6) 2020 procedure name: ath + bso + om + pln + pan for ovarian cancer.The patient demographics: (b)(6) year-old female.Height is 145 cm.Weight is (b)(6) kg.Additional event information: the product was used on the fascia of abdominal wall.The wound edge was ligated with size 0 vicryl and sutured using 2 pieces of sxpp1a 301 from both sides.Q.Whether there were defects of the suture such as loosening and breakage? a.Since it was before the operation for ileus, it has not been confirmed, but when it was confirmed with ct images, the size of the hernia was as large as 10 cm, and therefore the surgeon considers that it was highly likely that the hernia was caused not by the rupture of the suture but by the tissue rupture.The peritoneum was also sutured independently.Q.How long has the incisional hernia been detected since the initial surgery? a.Ovarian cancer surgery was performed on (b)(6) 2020, and abdominal incisional hernia was already present when ct was performed on (b)(6).Q.What was the procedure for ventral incisional hernia? a.Nothing in particular.Since the patient has ovarian cancer, in consideration of the possibility of recurrence, it is only for the treatment of ventral incisional hernia and no reoperation will be performed.Q.Is there a causal relationship between ileus and this case? a.The patient has been hospitalized since 8/8 for adhesive ileus.There was no causal relationship with ventral incisional hernia.Current status of the patient: the patient has been hospitalized.Progress: the patient has been hospitalized since 8/8 for adhesive ileus.There was no causal relationship with ventral incisional hernia.There was no particular procedure for ventral incisional hernia.Since the patient has ovarian cancer, in consideration of the possibility of recurrence, it is only for the treatment of ventral incisional hernia and no reoperation will be performed.Health injury details: ovarian cancer surgery was performed on (b)(6) 2020, and abdominal incisional hernia was already present when ct was performed on october 1.Treatment details: nothing in particular.Since the patient has ovarian cancer, in consideration of the possibility of recurrence, it is only for the treatment of ventral incisional hernia and no reoperation will be performed.Treatment plan: surgery for adhesive ileus is scheduled on 8/20.Seriousness: serious.Product use details: the product was used on the fascia of abdominal wall.The wound edge was ligated with size 0 vicryl and sutured using 2 pieces of sxpp1a 301 from both sides.There was probably no problem with the suture, such as loosening or breaking.Since it was before the operation for ileus, it has not been confirmed, but when it was confirmed with ct images, the size of the hernia was as large as 10 cm, and therefore the surgeon considers that it was highly likely that the hernia was caused not by the rupture of the suture but by the tissue rupture.The peritoneum was also sutured independently.Surgeon¿s comment: the cause was a rupture in the fascia, and it has not been determined that the suture breakage caused the fascia rupture.Other contributing factor: abdominal pressure due to obesity.Please provide the patient's demographic information including age, weight, bmi at the time of index procedure: female, 67 years, (b)(6) kg, 145cm.Date and name of index surgical procedure? (b)(6) 2020, abdominal total hysterectomy was performed.(+bso +om +pln +pan) the diagnosis and indication for the index surgical procedure? ovarian cancer.Were any concomitant procedures performed? no further information is available.What symptoms did the patient experience following the index surgical procedure? onset date? an abdominal incisional hernia occurred and it was found by ct examination on (b)(6) 2020.Please clarify what is meant by 'abdominal wall scar hernia'.Was this an incisional hernia? abdominal incisional hernia.Other relevant patient history/concomitant medications? =>no further information is available.On what tissue was the suture used? fascia of abdominal wall.What was the tissue condition (normal, thin, calcified, fragile, diseased)? no further information is available.Was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? no further information is available.Were two reverse stitches performed across the incision prior to closure? no further information is available.Please describe any medical/surgical intervention required for this suture event including dates and results.No intervention was performed.Since the patient has ovarian cancer and may eventually recur, surgery is not planned solely for abdominal incisional hernia.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? although not actually observed, the surgeon believed that the suture was not defective.What is the physician¿s opinion as to the etiology of or contributing factors to this event? as confirmed by ct images, the size of the hernia is as large as 10 cm, so it is highly possible that the tissue was torn rather than the thread to be broken.Is it believed that the suture caused or contributed to the reported ileus? no.What is the patient's current status? the patient has been hospitalized.Product lot number? no further information is available.No further information will be provided.Trade name: irgacare®.Active ingredient(s): triclosan.Dosage form: suture/solid/parenteral.Strength: = 2360 g/m.Related events captured via 2210968-2021-07866, 2210968-and 2210968-2021-08539.

Event Description

It was reported that a patient underwent an unspecified open ob-gyn procedure on an unknown date and suture was used.An abdominal wall scar hernia occurred and the patient was hospitalized for ileus.Additional information has been requested.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CTB-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12481834
• MDR Text Key: 271717907
• Report Number: 2210968-2021-08538
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227712
• UDI-Public: 10705031227712
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2021

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: SXPP1A301
• Device Catalogue Number: SXPP1A301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 64