MAUDE Adverse Event Report: ETHICON INC. TEFLON PLEDGETS UNKNOWN PRODUCT; PATCH, PLEDGET AND INTRACARDIAC

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

Patient Problems Abscess (1690); Fistula (1862); Post Operative Wound Infection (2446)

Event Type  Injury  

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.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe there was any deficiency with the ethicon sutures used in this procedure leading to post op complications? does the surgeon believe that ethicon sutures involved caused and/or contributed to the post-operative complication described in the article? citation: ann surg treat res 2015;88(6):299-305; doi: http://dx.Doi.Org/10.4174/astr.2015.88.6.299.

Event Description

It was reported in journal article with title: a novel pancreaticogastrostomy method using only two transpancreatic sutures: early postoperative surgical results compared with conventional pancreaticojejunostomy author(s): jeong yeon lee, eun young kim, jun suh lee, soo ho lee, gun hyung na, tae ho hong, young kyoung you, dong goo kim citation: ann surg treat res 2015;88(6):299-305; doi: http://dx.Doi.Org/10.4174/astr.2015.88.6.299.The purpose of this retrospective study was to evaluate the surgical outcomes of pancreaticogastrostomy using two transpancreatic sutures with a buttress method through an anterior gastrostomy (pgt), and compare these results with our previous experience with pandreaticojejunostomy (pj) including the dunking and duct to mucosa methods after pancreaticoduodenectomy (pd).Between jan2005 and apr2013, a total of 171 patients underwent pd and were classified into three groups for pancreaticoenteric anastomosis: dunking pj group (n=67; n=40 male and n=27 female; mean age sd 60.4±9.8 years), mucosa pj group (n=41; n=23 male and n=18 female; mean age sd 61.1±13.0 years), and pgt group (n=63; n=32 male and n=31 female; mean age sd 61.1±10.6 years).In dunking pj group, 3-0 pds sutures were utilized in suturing the full thickness of the internal layer between pancreas and jejunum.In duct to mucosa pj, the anastomosis of jejunostomy and pancreatic duct was performed with 5-0 pds sutures.In pgt group, pancreaticogastrostomy was completed with two 4-0 prolene sutures with tfe polymer pledget (ethicon) buttresses on both upper and lower borders of the pancreas through the anterior gastrostomy.Among the 21 patients who developed postoperative pancreatic fistula (popf) under dunking pj group, patients were classified as grade a (n=14), grade b (n=5), grade c (n=2) and grade b+c (n=7).Moreover, out of 19 patients who developed popf under mucosa pj group, patients were classified as grade a (n=10), grade b (n=7), grade c (n=2) and grade b+c (n=9).Furthermore, of the 18 patients who developed popf under pgt group, patients were classified as grade a (n=14), grade b (n=3), grade c (n=1) and grade b+c (n=4).Other postoperative complications included intra-abdominal abscess (n=4 dunking pj group, n=5 mucosa pj group, and n=2 pjt group) and wound infection (n=8 dunking pj group, n=8 mucosa pj group, and n=12 pjt group).Pancreatic juice is secreted at the pancreatic stump, not only from the main duct but from several minor ducts, which can weaken the anastomosis and affect the development of popf.The minor leakage could be a fatal disadvantage of the duct to mucosa method, whereas our pgt method can be used easily without the limitation of pancreatic duct diameter.Additional information has been requested.

• Brand Name: TEFLON PLEDGETS UNKNOWN PRODUCT
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC
• 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: 7397716
• MDR Text Key: 104410261
• Report Number: 2210968-2018-71903
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K811872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/19/2018

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: 03/19/2018
• Initial Date FDA Received: 04/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention