MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

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

Patient Problems Failure to Anastomose (1028); Pain (1994); Not Applicable (3189)

Event Date 10/30/2019

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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of the index surgical procedure.The diagnosis and indication for the index surgical procedure? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was the suture placed, interrupted or continuous? what were current symptoms following the index surgical procedure? onset date? how was the anastomotic leak confirmed? was surgical intervention performed? if yes, date? if yes, please provide date and appearance of the suture during the second procedure? other relevant patient history/concomitant medications.Product code? lot number? if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event.What is the patient¿s current status?.

Event Description

It was reported that a patient underwent a bariatric procedure on (b)(6) 2019 and suture was used.Post-op, the patient presented at the local er.It was later discovered there was an anastomatic leak.The patient has been hospitalized for six days and has not improved.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent to the fda: 1/29/2020.Additional h6 patient code: 1994, 3189 ¿ surgical intervention.Additional information: a2, a3, b7.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure age: 57, gender: f, weight: -, bmi: 59.3%.Date and name of the index surgical procedure (b)(6); gastric sleeve.The diagnosis and indication for the index surgical procedure? morbid obese.On what tissue was the suture used? unknown.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? normal.How was the suture placed, interrupted or continuous? continuous.What were current symptoms following the index surgical procedure? onset date? she was admitted to whittier pres.Hospital for gastric pain.Ct scan they confirmed questionable fluid collection.On november 18, transferred the patient to methodist hospital.Ct scan revealed large air fluid collection adjacent to the spleen.How was the anastomotic leak confirmed? ct scan.Was surgical intervention performed? if yes, date? diagnostic laparoscopic and placement of drain performed at methodist on (b)(6).Patient was then transferred to cedars sinai on november 27th for stent placement.What is the patient¿s current status? the patient is at home.Note: event related to 11/20/2019 diagnostic laparoscopic and placement of drain reported via mw#2210968-2019-90938; event related to (b)(6) 2019 stent placement reported via mw#2210968-2020-00808.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9473786
• MDR Text Key: 176548550
• Report Number: 2210968-2019-90938
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR