MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B450

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

Patient Problems Adhesion(s) (1695); Pain (1994); Obstruction/Occlusion (2422)

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).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: please provide the patient's demographic information including weight, bmi at the time of index procedure: (b)(6) female.Date of index surgical procedure? unknown.The diagnosis and indication for the index surgical procedure? laparoscopic myomectomy.Lot number? unknown.On what tissue was the suture used? the sxpp1b450 was used in the muscle layer after myomectomy.And continuous sutures were made from the muscle layer to the serosa.How was the suture originally tied (multiple knots, square knot, etc.)? continuous.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? unknown.Was at least one reverse stitch performed prior to closure? yes.2 times.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown.What symptoms did the patient experience following the index surgical procedure? onset date? the patient visited the er with abdominal pain at 7 weeks postoperatively.The patient was diagnosed as strangulated ileus, then emergency surgery was performed.A suture protruding from the anterior wall of the uterus had penetrated the mesentery of the small intestine and adhered to it, forming a band.No necrosis of the small intestine was observed.Other relevant patient history/concomitant medications? unknown.Please describe any medical/surgical intervention required for this suture event including dates and results.The operation was completed with removal of the suture that formed the band.Can you describe the appearance of the stratafix suture during second procedure? a suture protruding from the anterior wall of the uterus had penetrated the mesentery of the small intestine and adhered to it, forming a band.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the puncture of the reverse stitch into the tissue may have been shallow, causing the suture to loosen, and the suture to spring back and expose.What is the patient's current status? the patient has been discharged from the hospital.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 laparoscopic myomectomy on an unknown date and a barbed suture was used in the muscle layer and continuous sutures were made from the muscle layer to the serosa.Two reverse stitches were performed, and the suture ends were cut not to protruding from the uterine serosa.Adspray was sprayed on the uterine surface.Post op, the patient was discharged from the hospital on the 4th postoperative day but visited the er with abdominal pain at 7 weeks postoperatively.The patient was diagnosed as strangulated ileus, then emergency surgery was performed.A suture protruding from the anterior wall of the uterus had penetrated the mesentery of the small intestine and adhered to it, forming a band.No necrosis of the small intestine was observed, and the operation was completed with removal of the suture that formed the band.The patient was discharged on the 7th postoperative day.No recurrence of intestinal obstruction was observed afterwards.No additional treatment is planned.The surgeon opined that there was a causal relationship between the product and event and believed that the puncture of the reverse stitch into the tissue may have been shallow, causing the suture to loosen, and the suture to spring back and expose.No additional information was provided.

• Brand Name: SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-1
• 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
• MDR Report Key: 13713969
• MDR Text Key: 290932719
• Report Number: 2210968-2022-01615
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236219
• UDI-Public: 10705031236219
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPP1B450
• Device Catalogue Number: SXPP1B450
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2022
• 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
• Patient Age: 42 YR
• Patient Sex: Female