MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Failure to Anastomose (1028); Abdominal Pain (1685); Fistula (1862); Hemorrhage/Bleeding (1888); Paresis (1998); Abdominal Distention (2601)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2021-10493 and 2210968-2021-10494.Citation: j.Clin.Med.2021, 10, 2181.Https://doi.Org/10.3390/ jcm10102181.

Event Description

Title: rate of post-operative pancreatic fistula after robotic-assisted pancreaticoduodenectomy with pancreato-jejunostomy versus pancreato-gastrostomy: a retrospective case matched comparative study.The present study aims to compare the post-operative outcomes of pancreaticogastrostomy and pancreaticojejunostomy after robotic pancreaticoduodenectomy.Between august 2014 and october 2019, 60 patients with a preoperative diagnosis of benign tumor or localized and resectable malignant tumor at the periampullary region who did not meet any of the exclusion criteria were selected for robotic pancreaticoduodenectomy and they were included in the study.There were 20 patients (13 males and 7 females, mean age 61.9 years, mean bmi 24.8+/-2.8 kg/m2) who underwent pancreaticogastrostomy, while 40 patients (27 males and 13 females, mean age 63.2, bmi 25.1 +/-3.4 kg/m2) underwent pancreaticogastrostomy.All pancreatic anastomoses in robotic pancreaticoduodenectomy until 2018 were pancreaticojejunostomy.Subsequently, the pancreaticogastrostomy anastomosis technique was adopted as the only method for pancreatic reconstruction during robotic pancreaticoduodenectomy.The pancreaticojejunostomy procedure was fashioned with an end-to-side duct-to-mucosa two-layer anastomosis with interrupted sutures.The pancreatic duct was secured to the jejunal mucosa using 5/0 prolene (ethicon) interrupted sutures.For the trans-gastric pancreaticogastrostomy anastomosis, the pancreatic parenchyma was sutured to the gastric mucosa using interrupted 4/0 pds ii (ethicon) sutures.The anterior gastrotomy was closed with a 3/0 pds (ethicon) running suture.Complications include biochemical leak (n=8), clinically relevant postoperative pancreatic fistula (n=7), delayed gastric emptying (n=3), grade c postoperative hemorrhage (n=3), pancreatitis (n=1), bile leakage (n=2), ascites (n=1), intrabdominal collection (n=3), readmission due to fever and associated fatigue with detected abdominal collection on ct-scan (n=2), and readmission due to abdominal pain, dyspepsia, abdominal distension associated with changes in bowel habit (n=3).In conclusion, the outcomes of post-operative pancreatic fistula are comparable between the two reconstruction techniques.Pancreaticogastrostomy may have a lower incidence of postoperative pancreatic fistula in patients with high-risk of pancreatic fistula.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12712273
• MDR Text Key: 278833906
• Report Number: 2210968-2021-10494
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2021
• 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