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

Model Number SXPP1A301

Device Problems Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Pneumonia (2011)

Event Date 03/22/2022

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).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.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 age, gender, weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? it was stated ¿there was a mistake in the placement method of the first tab so there was a possibility that the mistake might be the cause of the problem¿.Please provide further specifics on the mistake in the placement method.What tissue dehisced? how was the dehiscence managed? was the dehiscence only seen on ct scan? why was the ct scan performed? please describe any surgical intervention required for the wound dehiscence including date and findings.Were there any precipitating stress factors for the wound dehiscence? what symptoms did the patient experience (if any) following the index surgical procedure? onset date? other relevant patient history/concomitant medications? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? did the stratafix suture break post-op? if so, where was the break noted (termination, middle, end)? can you describe the appearance of the stratafix suture during second procedure, if applicable? did the tab on the stratafix suture break? if yes, does the surgeon think it broke intra-op or post-op? did the patient experience an intestinal obstruction or is there only a risk/possibility to cause an intestinal obstruction in the future? does the surgeon feel the pneumonia is related to the stratafix suture? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number? 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 a robot-assisted thoracoscopic subtotal esophagectomy, free jejunum and total gastrectomy on (b)(6) 2022 and a barbed suture was used.One week after the procedure, by taking ct images, it seemed that surgical wound dehiscence occurred, and the intestine was sunk into the abdominal wall.Upon examination, it was found that the barbed suture was used for the abdominal incision fascia.There were no complaints from the patient, and there were no subjective symptoms or abnormal appearance.The patient¿s hospitalization has been extended due to pneumonia and is still hospitalized at the same hospital.There is a possibility to cause intestinal obstruction eventually, but there are no particular treatment plans for now nothing the surgeon can do about it at this point.Since it was a judgment which was based only on the ct image, it is unknown whether the suture was broken or the tissue is torn.It was stated that it is possible, there was a mistake in the placement method of the first tab so there was a possibility that the mistake might be the cause of the problem.The surgeon commented that the first tab placement method was without fixing the figure 4, the tab was used as an anchor and pulled, so the tab may have cracked, which may be the cause of the surgical wound dehiscence.The current status of the patient is in the hospital.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).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: 1.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure unknown.2.The diagnosis and indication for the index surgical procedure? unknown.3.On what tissue was the suture used? abdominal fascia.4.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown.5.Was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? unknown.6.Were two reverse stitches performed across the incision prior to closure? unknown.7.It was stated ?there was a mistake in the placement method of the first tab so there was a possibility that the mistake might be the cause of the problem.?.Please provide further specifics on the mistake in the placement method.Unknown.What tissue dehisced? unknown.8.How was the dehiscence managed? unknown.9.Was the dehiscence only seen on ct scan? yes.10.Why was the ct scan performed? unknown.11.Please describe any surgical intervention required for the wound dehiscence including date and findings.Unknown.12.Were there any precipitating stress factors for the wound dehiscence? unknown.13.What symptoms did the patient experience (if any) following the index surgical procedure? onset date? there were no complaints from the patient, and there were no subjective symptoms or abnormal appearance.14.Other relevant patient history/concomitant medications? unknown.15.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? unknown.16.Did the stratafix suture break post-op? if so, where was the break noted (termination, middle, end)? unknown.17.Can you describe the appearance of the stratafix suture during second procedure, if applicable? unknown.18.Did the tab on the stratafix suture break? if yes, does the surgeon think it broke intra-op or post-op? unknown.19.Did the patient experience an intestinal obstruction or is there only a risk/possibility to cause an intestinal obstruction in the future?=>there were no complaints from the patient.Unknown.20.Does the surgeon feel the pneumonia is related to the stratafix suture? unknown.21.What is the physician?s opinion as to the etiology of or contributing factors to this event? there was a mistake in the placement method of the first tab so there was a possibility that the mistake might be the cause of the problem.22.What is the patient's current status? the patient is in the hospital.23.Lot number? unknown.Because of corona virus, sales reps can't contact the surgeon.Corrected information: h6.

• 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; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14209334
• MDR Text Key: 290081779
• Report Number: 2210968-2022-02964
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A301
• Device Catalogue Number: SXPP1A301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2022
• 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 Outcome(s): Required Intervention