MAUDE Adverse Event Report: ETHICON INC. STFX SPI PDS+ UNI VIO 9IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number SXPP1B455

Device Problem Positioning Problem (3009)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

(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.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.What was the date of the initial procedure? what tissue type and location of the suture placement? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? where did the suture start (top to bottom or bottom to top)? when suturing with stratafix symmetric, how far was the bite from the edge of the tissue? were any solutions used during closure (ie antimicrobial)? what date post op did the patient experience adhesions? how were the adhesions from the cuff to the bladder diagnosed? was a second procedure or surgical intervention performed? on what date was the second procedure? can you describe the appearance of the suture during the second procedure? was the suture intact and pulled through the tissue? do you have the status of suture for evaluation? did the operating surgeon observe any suture deficiency or anomaly before or during the suture placement? what is the patient age, weight, relevant patient history/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the surgeon opinion as to the relationship of the stratafix suture to the adhesions? what is the patient current status?.

Event Description

It was reported that the patient underwent hysterectomy on an unknown date and barbed suture was used.Post-op of the procedure, the patient experienced adhesions from the cuff to the bladder.It was reported that the patient experienced dehiscence.Additional information has been requested.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: what was the date of the initial procedure? unknown.What tissue type and location of the suture placement? vaginal cuff.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? unknown.Where did the suture start (top to bottom or bottom to top)? unknown.When suturing with stratafix symmetric, how far was the bite from the edge of the tissue? unknown.Were any solutions used during closure (ie antimicrobial)? unknown.What date post op did the patient experience adhesions? unknown.How were the adhesions from the cuff to the bladder diagnosed? unknown ,reported to the hospital by the surgeon.Was a second procedure or surgical intervention performed? unknown.On what date was the second procedure? can you describe the appearance of the suture during the second procedure? no rep was present.Was the suture intact and pulled through the tissue? not reported.Do you have the status of suture for evaluation? no.Did the operating surgeon observe any suture deficiency or anomaly before or during the suture placement? no.What is the patient age, weight, relevant patient historyconcomitant medications? not reported.What is physician¿s opinion as to the etiology of or contributing factors to this event? he was uncertain , did not know if it was related to the suture.What is the surgeon opinion as to the relationship of the stratafix suture to the adhesions? he was uncertain if there was a relationship and has used stratafix again.What is the patient current status? according to the surgeon the patient is doing fine.

• Brand Name: STFX SPI PDS+ UNI VIO 9IN 0 S/A CT-1
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8392328
• MDR Text Key: 137883098
• Report Number: 2210968-2019-79271
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031240834
• UDI-Public: 10705031240834
• Combination Product (y/n): N
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1B455
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention