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); Death (1802); Sepsis (2067); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

(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.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon product (pds suture) involved caused and/or contributed to the postoperative complications described in the article? does the surgeon believe that ethicon suture (pds suture) caused/ contributed to the death (due to post- operative bile leakage and sepsis)? does the surgeon believe there was any alleged deficiency with the ethicon suture (pds suture) products used in this procedure? what are the additional complications mentioned in the article and did the ethicon pds suture device cause/contributed to the reported events in the article? would the surgeon like to speak with ethicon medical and engineering (translation is available)? citation: arch surg.2006; 141: 690-694.See attached article for reference 2210968-2019-80636.[(b)(4)].

Event Description

It was reported via journal article "title: bile leakage and liver resection; where is the risk?" authors: lorenzo capussotti, md; alessandro ferrero, md; luca viganò, md; enrico sgotto, md; andrea muratore, md; roberto polastri, md citation: arch surg.2006; 141: 690-694.The aim of this study was to investigate the perioperative risk factors related to postoperative bile leakage, placing particular focus on anatomical and technical variables.Prospectively collected clinical data on 610 consecutive patients (369 male and 241 female patients; age range: 2 to 86 years old) who underwent liver resection in our department from january 1, 1989, through january 31, 2003, were reviewed retrospectively.During the surgical procedure, the parenchymal transection was always performed by using a crushing clamp technique and absolok extra absorbable clips (ethicon) for any vessel or bile duct.When necessary, biliostasis was attained by suturing the identified bile leakage site with pds ii 5-0 or 6-0 absorbable monofilament (ethicon).Reported complications included post-operative bile leakage (n-22) in which bile leakage spontaneously healed in 15 patients, endoscopic sphincterotomy in 7, percutaneous drainage in 3, and re-operation in 2 patients, one patient with bile leakage died due to onset of sepsis, and among patients with bile leakage, 4 patients had additional complications.It was concluded that hepatectomies including segment 4, especially if performed for peripheral cholangiocarcinoma, place the patient at higher risk for postoperative bile leakage.Careful surgical technique is mandatory to avoid bile leakage.Treatment of the cut surface with fibrin glue reduces the risk of postoperative bile leakage.Use of these techniques is warranted to reduce bile leakage in hepatic resection.

• 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 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8541727
• MDR Text Key: 142816840
• Report Number: 2210968-2019-80635
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• 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
• Treatment: ABSOLOK CLIPS
• Patient Outcome(s): Death; Required Intervention