MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 9IN 3-0 S/A SH-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1B453

Device Problems Leak/Splash (1354); Melted (1385)

Patient Problems Failure to Anastomose (1028); Wound Dehiscence (1154); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: patient¿s initials: unknown.Current status: the patient is hospitalized currently.Surgeon¿s comments: the surgeon is not sure the event was caused by the stratafix.However, v-loc still remained at the reoperation.Thus, he doubted the stratafix.Other contributing factors: the other possible causes are ¿the condition of the remaining stomach was not good, and it was swollen¿, ¿interference between the stratafix and v-loc¿, ¿the stratafix melted all at once¿, and ¿back stitch by the stratafix was not performed¿.The lot number is unknown.What was the date of the initial procedure? end of (b)(6) 2019.The date is unknown.The patient demographic info: age, weight, bmi at the time of index procedure - no further information is available.Other relevant patient history/concomitant medications - no further information is available.What was the condition of the tissue (normal, diseased, weakened)? the condition of the remaining stomach was not good, and it was swollen.How was the suture placed (starting at end or middle of incision)? the stratafix spiral was used on the right half, and they were overlapped at the middle.Was the loop intact when the suture was placed in the patient? no further information is available.Was any deficiency or anomaly noted on the suture prior to use? no further information is available.Was any solution used to irrigate the tissue prior to closure? no further information is available.Can you describe the appearance of the stratafix suture during second procedure? when checking the common hole site, there was no stratafix spiral.What was the condition of the loop during the second procedure? no further information is available.What is physician¿s opinion as to the etiology of or contributing factors to this event? the surgeon is not sure the event was caused by the stratafix.However, v-loc still remained at the reoperation.Thus, he doubted the stratafix.The other possible causes are ¿the condition of the remaining stomach was not good, and it was swollen¿, ¿interference between the stratafix and v-loc¿, ¿the stratafix melted all at once¿, and ¿back stitch by the stratafox was not performed¿.Can you identify the lot number of the stratafix spiral suture? the lot number is unknown.Do you have the device or any samples to return for evaluation? no sample will be returned.What is the patient¿s current status? the patient is hospitalized currently.

Event Description

It was reported that a patient underwent a laparoscopic distal gastrectomy and b-ii reconstruction surgery at the end of (b)(6) 2019 and barbed suture was used.It was reported that after the surgery, the sutured part became open and leakage occurred.The barbed suture and v-loc were used for common hole closure.V-loc was used on the left half of the common hole, and the barbed suture was used on the right half, and they were overlapped at the middle.The v-loc was used by continuous suturing.After closing the left half of the hole with the v-loc, the suture was not cut, and the rest of the suture was used for lifting the common hole.Since the stitch was done from the outside of the hole to inside , when the common hole was lifted by the v-loc, the mucous membrane was exposed to outside.The surgeon thinks this condition might have not been good.Suturing with the barbed suture was done as usual after passing the suture through the loop.Back stitches were not done at the end of suturing.Instead, at the middle of the hole, about two stitches of barbed suture were put over the stiches of v-loc so that barbed suture and v-loc overlapped.Leakage test was not performed due to the surgeon¿s fatigue.One week after the surgery ((b)(6) 2019), leakage occurred, so reoperation was performed.When checking the common hole site, there was no barbed suture.The surgeon thought that it might have melted due to alkali such as bile, but the surgeon also thought that it was too fast for the suture to melt.It was noticed that the common hole was covered with the small intestine, and the surgeon thought there was a piece of suture there.But it was discarded, so the surgeon is not sure of it now.The dehisced site of the common hole was closed using the polysorb.The surgeon is not sure the event was caused by the barbed suture.However, v-loc still remained at the reoperation.Thus, the surgeon doubted the barbed suture.Other possible causes are ¿the condition of the remaining stomach was not good, and it was swollen¿, ¿interference between the barbed suture and v-loc¿, ¿the barbed suture melted all at once¿, and ¿back stitch by the barbed suture was not performed¿.Additional information has been requested.

• Brand Name: SFX SPI PDS+ UNI VIO 9IN 3-0 S/A SH-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3,; san lorenzo
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9527469
• MDR Text Key: 189080552
• Report Number: 2210968-2019-91373
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031240827
• UDI-Public: 10705031240827
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: SXPP1B453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• 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