MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Model Number PDP316H

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

Patient Problems Failure to Anastomose (1028); Fever (1858); Fistula (1862); Unspecified Infection (1930); Pain (1994)

Event Date 07/13/2022

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.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.(b)(4).Attempts are being made to retrieve the device.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.Name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? please describe any medical/surgical intervention required for this suture event, including the dates of both surgical interventions and results.It was stated that re-operation occurred on 2 more occasions: what was the finding during the first re-operation? what new suture was used for the re-operation? if another pds suture was used during the first re-operation, what was the finding on the second re-operation? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.Note: events reported via 2210968-2022-06065, 2210968-2022-06066.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used for anastomosis.Following the procedure, the patient was discharged and after 7 days, returns with a fistula.The patient underwent reoperation on two more occasions.Additional information was requested.

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.Additional information: a2, a3, a6, b7, h6 additional information was requested, and the following was obtained: cient white race, 31 years old, female, dbt, a native of san nicolas, bsas province, with bmi 51.52 at the beginning of treatment, weight 123 kg, height 1.54, and at the time of surgery had a weight loss of 7.5 kg.Gastric bypass is performed laparoscopically the suture (pds 3/0) was used to close the gastrojejunal gap after mechanical suture firing.A continuous two-way closure of the gastrojejunal gap was performed and in the middle of the second round the suture was cut but the end was correctly identified and the final knot was concluded.The tissue was of normal consistency.The suture was placed continuously.The suture is finished with 4 knots.A week after the first intervention, the patient was re-admitted with abdominal pain and fever and it was decided to relaparoscopy, observing an opening in the anterior and middle area of the closure of the gastrojejunal gap.Separate stitches were made with pds until the defect was closed in a context of peritonitis.The indemnity of the entire continuous suture is not clearly identified, profuse lavage is performed and then drainage is performed to both subphrenic, fsd and adjacent to the anastomosis, which did not take long to manifest the presence of a fistula at 48 hours.The suture had also been used in the jejunojejunoanastomosis without difficulty and in the reinforcements of the pauch and remnant stomach.To date and with 40 days since his first intervention, he has been robed 3 times 1 bypass surgery 2 surgery, suture lavage and drainage 3 surgery, suture lavage drainage and feeding jejunostomy 4 repositioning surgery of the jejunostomy due to perijejunal collection and partial detachment of the same.In the first surgery, a cut is produced in the suture (pds 3/0) of the gastrojejunoanastomosis in the second round of closure.The patient is morbidly obese with comorbidities such as poorly controlled dbt and is a nurse.The initial symptoms were 6 days after the bypass surgery where she began with abdominal pain in the epigastrium and in the right hypochondrium and fever.In our experience with gastric bypass, it is rare for fistulization to occur on the anterior face of the gastrojejunum, since we perform a 2nd closure and the ones we have had are on the right lateral face or posterior to the mechanical suture line.Seeing that the suture was cut during the closure, i think that perhaps this suture was weak and could have been cut with some episode of post op effort (nausea, vomiting, etc).We performed the methylene blue test intraoperatively, which was negative.The current status of the patient continues to be critical in the icu with a tracheostomy with abdominal drains with a fistula and currently with a persistent febrile curve.The video of the surgery or more information is available.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 provided photos or vidieos for review.Will the device be returned for evaluation? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PDS+ VIO 27IN 3-0 S/A SH
• 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 ; 9083863534
• MDR Report Key: 15128241
• MDR Text Key: 296846967
• Report Number: 2210968-2022-06067
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031048027
• UDI-Public: 10705031048027
• Combination Product (y/n): Y
• Reporter Country Code: AR
• PMA/PMN Number: K061037
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: PDP316H
• Device Catalogue Number: PDP316H
• Device Lot Number: SAMMCX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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: 31 YR
• Patient Sex: Female
• Patient Race: White