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

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Fistula (1862); Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446); Not Applicable (3189)

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.No specific patient information regarding events has 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.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? what was the product code for the 4-0 absorbable suture used? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: j am coll surg.2013.Doi: http://dx.Doi.Org/10.1016/j.Jamcollsurg.2012.10.009.[(b)(4) - chen 2013.Pdf].

Event Description

It was reported via journal article title: novel entirely continuous running suture of two-layer pancreaticojejunostomy using only one polypropylene monofilament suture authors: yonghua chen, md; chunlu tan, md; hao zhang, md; gang mai, md; nengwen ke, md; xubao liu, md.Citation: j am coll surg.2013.Doi: http://dx.Doi.Org/10.1016/j.Jamcollsurg.2012.10.009.The authors introduced a new, convenient, and secure duct to mucosa procedure for pancreaticojejunostomy (pj) with a two-layer entirely continuous running suture using only 1 polypropylene monofilament suture.The authors performed this new method during pancreaticoduodenectomy (pd) on 54 consecutive patients (37 men, 17 women; age range: 38 to 75 years old) from december 2010 to june 2012.During the surgical procedure after pd, hemostasis was achieved using an electrocautery or the suture technique using an absorbable 4-0 sutures.A matching stent tube was inserted into the main pancreatic duct of the pancreatic remnant from the cut end and tied to the pancreatic parenchyma around the main pancreatic duct using an absorbable 4-0 suture with sh-1 needle.A posterior row of continuous running suture using prolene 4-0 sutures with double needles was placed between the duct/parenchyma and the jejunal whole layer.Suturing begun at the point on the caudal side of the pancreatic duct/parenchyma, that is, between 7 o¿clock position on the pancreatic side and 5 o¿clock position on the jejunal side, and works toward the cranial side but was not tightened.The anterior row was similarly sutured by continuous running suture using previous suture.The outer-layer anastomosis was completed by continuous running suture while being tightened using the previous suture between the pancreatic parenchyma and jejunal seromuscular layer from anterior to posterior walls (9 o¿clock position on pancreas side) and then back to anterior walls (3 o¿clock position on pancreas side).The pancreatic tube was fixed at the end of the jejunal loop using purse-string suture with an absorbable 4-0 sutures and then externalized.Reconstruction was completed after end to side biliary anastomosis with one-layer interrupted suture using absorbable 4-0 sutures and end to side gastrojejunostomy in pd using stapling devices.The pancreatic tube was exited from the abdominal wall.Subsequently, the proximal end of the jejunal loop around the pancreatic tube was fixed to the abdominal wall using 3 absorbable 4-0 sutures.The anastomotic area of pj and biliary anastomosis were drained separately with open drains.Reported complications included post-operative pancreatic fistula (n-6), post-operative hemorrhage (n-2), intra abdominal collection (n-3) which required conservative management (n-2), percutaneous approach (n-1), intra-abdominal abscess (n-2) which required conservative management, septicemia (n-3), and wound infection (n-8).It was reported that the most important factor in the prevention of pancreatic fistula is technical precision and gentleness in construction of the pancreatic anastomosis.It was concluded that the modified pj technique can be considered as an alternative treatment for pd, and can be applied easily in pancreatic surgery.

• 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: 7611838
• MDR Text Key: 111436391
• Report Number: 2210968-2018-73536
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133356
• 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: 05/28/2018

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: 05/28/2018
• Initial Date FDA Received: 06/18/2018
• 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