MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 that 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 the ethicon products used in this procedure? citation: liver transpl.2018.Doi: 10.1002/lt.25074 (b)(4).

Event Description

It was reported via journal article: "title: long-term analysis of biliary complications after duct-to-duct biliary reconstruction in living donor liver transplantations" authors: sung yeon hong, xu-guang hu, hyun young lee, je hwan won, jin woo kim, xue-yin shen, hee-jung wang, bong-wan kim citation: liver transpl.2018.Doi: 10.1002/lt.25074 the study aims to evaluate the long-term outcomes of duct-to duct (dd) biliary reconstruction using 7-0 suture and to identify the risk factors of biliary complications (bcs) after living donor liver transplantation (ldlt).Between november 2006 and december 2015, a total of 140 ldlt recipients (104 male and 36 female patients; age range: 23 to 70 years old) underwent dd biliary reconstruction in a (b)(6) hospital and were included in the study.Among the 140 ldlts, 102 were performed with right lobe grafts, 20 at the left lobe, and 18 at the right posterior sector.During the duct-to-duct anastomosis, both 3 and 9 o¿clock corners of the graft¿s and recipient¿s bile duct opening were suture-anchored by double-arm needle prolene 7-0.Then, the 3 o¿clock corner suture was tied and the posterior wall of the bile ducts was sutured continuously from a 3 to a 9 o¿clock direction.The suture was performed in the manner of a duct-to-mucosa anastomosis, which was conducted as transductal stitches on the graft¿s duct and transmucosal stitches on the everted recipient¿s duct.(12, 14) after completion of the posterior wall suture, the bile ducts¿ anterior walls were sutured in the same manner as the posterior wall anastomosis using the other needle, from the 3 to 9 o¿clock direction.The distance between each stitch was about 0.5 to 0.7 mm.Reported complications included case 1, a (b)(6) male patient with bile leakage (bl) which required endoscopic retrograde biliary drainage (erbd), case 2, a (b)(6) male patient with bl and biliary stricture (bs) which required endoscopic naso-biliary drainage (enbd) and percutaneous transhepatic biliary drainage (ptbd), case 3, a (b)(6) male patient with bl and bs which required percutaneous drainage (pcd) and ptbd, case 4, a (b)(6) male patient with bl and bs which required pcd and ptbd, case 5, a (b)(6) male patient with bl which required erbd, case 6, a (b)(6) female patient with bs which required ptbd, case 7, a (b)(6) male patient with bs which required ptbd, case 8, a (b)(6) female patient with bs which required ptbd, case 9, a (b)(6) female patient with bs which required ptbd, case 10, a (b)(6) male patient with bs which required ptbd, case 11, a (b)(6) male patient with bl which required endoscopic sphincterectomy (est), case 12, a (b)(6) female patient with bl and bs which required erbd and ptbd, case 13, a (b)(6) male patient with bl and bs which required enbd and ptbd, case 14, a (b)(6) male patient with bs which required ptbd, case 15, a (b)(6) male patient with bs which required ptbd, case 16, a (b)(6) male patient with bs which required ptbd, case 17, a (b)(6) male patient with bs which required ptbd, case 18, a (b)(6) male patient with bs which required ptbd, case 19, a (b)(6) male patient with bs which required ptbd.It was concluded that dd anastomosis using 7-0 suture combined with ebs could provide favorable long-term outcomes after ldlt, which should thus be considered the surgical technique of choice for ldlts.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 7659088
• MDR Text Key: 113064479
• Report Number: 2210968-2018-74035
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2018

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
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• 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
• Patient Age: 50 YR