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); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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 ethicon products involved (pds ii suture, prolene suture) caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (pds ii suture, prolene suture) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics for patients who utilized pds ii suture and prolene suture that experienced anastomotic biliary strictures, bile duct stones, anastomotic bile leak citation: jama surg.2019;154(5):431-439.Doi:10.1001/jamasurg.2018.5527.

Event Description

It was reported via journal article: "title: assessment of anastomotic biliary complications in adult patients undergoing high-acuity liver transplant".Authors: fady m.Kaldas, md; islam m.Korayem, md; tara a.Russell, md; vatche g.Agopian, md; antony aziz, bs; joseph dinorcia, md; douglas g.Farmer, md; hasan yersiz, md; jonathan r.Hiatt, md; ronaldw.Busuttil, md, phd.Citation: jama surg.2019;154(5):431-439.Doi:10.1001/jamasurg.2018.5527.The specific aims of the study were to evaluate perioperative donor and recipient risk factors for anastomotic biliary complications (abc), as well as the risk factors and outcomes associated with different types of abcs in a population undergoing high-acuity liver transplant (lt).This retrospective review of a prospectively maintained database was conducted for 503 lt recipients (317 male [62.3%] and 192 female [37.7%]; median age, 58 years [iqr, 50-63 years]); median bmi: 27 (24-31)) who underwent 509 lts from january 1, 2013, to june 30, 2016, with a minimum follow-up of 1 year completed on june 30, 2017.During the procedure, anastomoses were performed in an interrupted fashion using absorbable polydioxanone suture (pds; ethicon) or nonabsorbable polypropylene suture (prolene; ethicon).Absorbable suture material was used for 387 lts including all 33 hepaticojejunostomies and nonabsorbable suture was used for duct-to-duct anastomosis in 122 lts.Reported complications for patients who used absorbable suture material included anastomotic biliary strictures (n-?) in which the patients underwent endoscopic retrograde cholangiopancreatography (ercp)with stenting, percutaneous transhepatic biliary drainage, surgical revision, and observation, bile duct stones (n-?) which were managed by ercp, sphincterotomy, and stone extraction, and anastomotic bile leaks (n-?) in which ercp with stenting was used, surgical intervention, and observation.Reported complications for patients who used non-absorbable suture material included anastomotic biliary strictures (n-?) in which the patients underwent endoscopic retrograde cholangiopancreatography (ercp)with stenting, percutaneous transhepatic biliary drainage, surgical revision, and observation, bile duct stones (n-?) which were managed by ercp, sphincterotomy, and stone extraction, and anastomotic bile leaks (n-?) in which ercp with stenting was used, surgical intervention, and observation.The optimal choice of suture material for biliary reconstruction has been debated since the early development of lt.The authors found the use of nonabsorbable suture material to be significantly associated with an increased risk of developing abcs, especially anastomotic biliary strictures and bile duct stones, compared with use of absorbable suture.The permanent presence of nonabsorbable suturemay act as a nidus for stone formation.The incidence of abcsinltremainselevated.Despite the highacuity t cohort in this study, abcs were not associated with the meldscore.Hepatic artery thrombosis is the strongest risk factor for abcs, followedby hepatic artery stenosis, second lt, recipient hcc, use of nonabsorbable suture, donor hypertension, and donor anoxia.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• 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.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10788724
• MDR Text Key: 217321502
• Report Number: 2210968-2020-08686
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/04/2020
• 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