MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B415

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

Patient Problems Failure to Anastomose (1028); Unspecified Tissue Injury (4559)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a gastric bypass procedure on (b)(6) 2022 and barbed suture was used.The tissue was torn at the gj anastomosis and the surgeon opines that it is associated with the barbed suture.The patient required revision surgery.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.Trade name: irgacare®, active ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength: 2360 g/m.Attempts have been 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.Additional information was requested, and the following was obtained: the surgeon had to revise the surgery as patient had a leak.Surgeon thought patient drank too much water and put pressure on the tissue and mentioned the patient didn't have great tissue but has felt since that the tissue may have been torn by the stratafix suture when i spoke to the surgeon yesterday, she indicated that the icu at calvary john james hospital had overloaded the patient with fluid x 3litres and she had to transfer the patient back to calvary bruce private to revise the surgery because of that issue.She did not mention to me anything about the sutures.I will investigate further regarding your questions as this seems to be something the surgeon has faced twice regarding fluid volume.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.How many 2/0 x15cm stratafix sutures sxpp1b415 tore through the tissue at the gi anastomosis? how many 0 x45cm stratafix sutures tore through the tissue at the gi anastomosis? in addition to the initial gastric bypass surgery on (b)(6) 2022, how many revision surgeries did the patient undergo? please provide dates and results.Please provide the patient's age, weight, bmi at the time of index 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)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history besides diabetes/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? product code and lot number for each suture that contributed to the tear in the gastric tissue? if applicable, will product be returned? if so, please provide the return date and tracking information.Related medwatch reports: 2210968-2022-06293 and 2210968-2022-06294.

• Brand Name: SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15166870
• MDR Text Key: 297312417
• Report Number: 2210968-2022-06292
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031235885
• UDI-Public: 10705031235885
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: K150670
• 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
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPP1B415
• Device Catalogue Number: SXPP1B415
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2022
• 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 Sex: Female