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); Abscess (1690); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Perforation (2001); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Title: conservative drain management increases the incidence of grade b postoperative pancreatic fistula without increasing serious complications: does persistent drainage reflect the quality of pancreatic surgery or institutional policy? the aim of this study was to compare the clinical burden of patients who were treated with persistent drainage for 21 days, patients who received other treatments for grade b popf, and patients with bl.Total of 292 patients who underwent pancreaticoduodenectomy or distal pancreatectomy between 2013 and 2015.Patients with grade b popf were categorized into those receiving persistent drainage alone (b-drain) and those receiving other treatments (b-other).The clinical burden of these groups and patients with biochemical leakage (bl) was compared.The pancreatic anastomosis used during pd is a duct-to-mucosal, end-to-side pancreaticojejunostomy.The duct-to-mucosal anastomosis was created by interrupted 6-0 pds-ii sutures (ethicon, (b)(4)) and covered by (b)(6) with transfixing 3-0 prolene sutures (ethicon).Pancreatic and biliary stents were placed over the pancreatic and biliary anastomoses and externalized.At least one drain was placed close to the pancreatic anastomosis in all cases.For dp, the pancreas was transected by stapling devices, and one drain was placed near the remnant pancreatic stump in all cases.Prophylactic antibiotics were discontinued within 48 hours, and the drain output fluid was analyzed daily to measure amylase levels.The drain(s) were removed on pod 4 in patients whose amylase levels in the drain fluid were less than three times the normal upper limit of serum amylase on pod 3.Reported complications included ileus(n=3), gastrointestinal perforation (n=3), bleeding (n=2), abscess in (n=1), bile leakage (n=1), and necrotic pancreas (n=1), biliary leakage, grade b/c postoperative fistula (n=97), chyle leakage with infectious fluid in conclusion under conservative drain management, patients with grade b popf frequently experienced persistent drainage alone and the clinical burden of b-drain group and bl group was comparable.

Manufacturer Narrative

(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 2210968-2021-10836.Citation cite: j hepatobiliary pancreat sci.2020;27:1011¿1018.Doi: 10.1002/jhbp.838.

Manufacturer Narrative

(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 2210968-2021-10836.Citation cite: j hepatobiliary pancreat sci.2020;27:1011¿1018.Doi: 10.1002/jhbp.838.

Manufacturer Narrative

(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 2210968-2021-10836.Citation cite: j hepatobiliary pancreat sci.2020;27:1011¿1018.Doi: 10.1002/jhbp.838.

Event Description

Title: conservative drain management increases the incidence of grade b postoperative pancreatic fistula without increasing serious complications: does persistent drainage reflect the quality of pancreatic surgery or institutional policy? the aim of this study was to compare the clinical burden of patients who were treated with persistent drainage for > 21 days, patients who received other treatments for grade b popf, and patients with bl.Total of 292 patients who underwent pancreaticoduodenectomy or distal pancreatectomy between 2013 and 2015.Patients with grade b popf were categorized into those receiving persistent drainage alone (b-drain) and those receiving other treatments (b-other).The clinical burden of these groups and patients with biochemical leakage (bl) was compared.The pancreatic anastomosis used during pd is a duct-to-mucosal, end-to-side pancreaticojejunostomy.The duct-to-mucosal anastomosis was created by interrupted 6-0 pds-ii sutures (ethicon, somerville, nj, usa) and covered by jejunal serosa with transfixing 3-0 prolene sutures (ethicon).Pancreatic and biliary stents were placed over the pancreatic and biliary anastomoses and externalized.At least one drain was placed close to the pancreatic anastomosis in all cases.For dp, the pancreas was transected by stapling devices, and one drain was placed near the remnant pancreatic stump in all cases.Prophylactic antibiotics were discontinued within 48 hours, and the drain output fluid was analyzed daily to measure amylase levels.The drain(s) were removed on pod 4 in patients whose amylase levels in the drain fluid were less than three times the normal upper limit of serum amylase on pod 3.Reported complications included ileus(n=3), gastrointestinal perforation (n=3), bleeding (n=2), abscess in (n=1), bile leakage (n=1), and necrotic pancreas (n=1), biliary leakage, grade b/c postoperative fistula (n=97), chyle leakage with infectious fluid in conclusion under conservative drain management, patients with grade b popf frequently experienced persistent drainage alone and the clinical burden of b-drain group and bl group was comparable.

• 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
• MDR Report Key: 12746938
• MDR Text Key: 285258707
• Report Number: 2210968-2021-10835
• 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,health professional,l
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention