MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Death (1802); Sepsis (2067)

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.The following information was requested, but unavailable: was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (pds ii, prolene, vicryl plus, unknown absorbable suture) involved caused and/or contributed to the post-operative complication of sepsis and death described in the article? does the surgeon believe there was any deficiency with the ethicon products (pds ii, prolene, vicryl plus, unknown absorbable suture) used in this procedure? would the surgeon like to speak with ethicon medical and engineering (translation is available)? could not provide additional information.Citation: the american surgeon (2018); 84:371-376.(b)(4).

Event Description

It was reported via journal article "title: addition of mesh reinforcement for pancreatic stump and braun enteroenterostomy after pancreaticoduodenectomy: a single institution experience".Authors: jie hua, md, hongbo meng, md, zhigang he, md, le yao, md, ph.D, wei sun, md, zhenshun song, md, ph.D.Citation: the american surgeon (2018); 84:371-376.This study investigated a new modification of pd by adding mesh reinforcement for the pancreatic stump and braun enteroenterostomy with the aim of reducing postoperative pancreatic fistula (popf) and delayed gastric emptying (dge), respectively.From november 2010 to april 2015, 81 consecutive patients (male 51 and female 30; age range: 24-80; bmi: 18.1-29.6) who underwent modified pd were retrospectively reviewed.After the pd specimen had been removed, hemostasis of the bleeding points of the pancreatic stump was achieved with either 4-0 prolene nonabsorbable sutures (ethicon) or electrocautery.Two sutures were typically placed in both the superior and inferior borders of the pancreatic stump for dragging.The catheter was secured to the pancreatic duct using 4-0 vicryl plus absorbable sutures (ethicon), preventing catheter migration.A mesh-like running suture of the pancreatic stump using 4-0 prolene nonabsorbable sutures (ethicon) was performed, aiming to reduce the wound of the pancreatic stump.Briefly, running sutures were performed from the inferior border to the superior border.To maximally seal the pancreatic stump, running sutures from the superior border back to the inferior border were performed to form mesh-like intersections with the previous sutures.The transected jejunum was then brought through the bed of the resected duodenum and a two-layer end-to-end invagination pj using 4-0 prolene nonabsorbable sutures (ethicon) was performed.The hepaticojejunostomy was performed downstream from the pj (approximately 10 cm) using 4-0 polydioxanone (pds) ii absorbable sutures (ethicon) in a single-layer continuous nonlocking fashion.The gastrojejunostomy was performed 60 cm distal to the pj with an outer interrupted layer of 3-0 silk and an inner continuous layer of 3-0 absorbable suture (ethicon).Reported complications included postoperative pancreatic fistula (n-8), delayed gastric emptying (n-26), postpancreatectomy hemorrhage (n-6), bile leak (n-3), intra-abdominal collection (n-13), wound infection (n-8), abdominal wound dehiscence (n-1) in which reoperation was performed, other (n-9), and one patient experienced grade c popf and soon developed sepsis leading to death.In conclusion, the new modified digestive reconstruction after pd seems safe and reliable with low clinically relevant popf and dge rates.Further prospective controlled trials are essential to support these results.

• Brand Name: SUTURE UNKNOWN
• 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: 8493922
• MDR Text Key: 141298034
• Report Number: 2210968-2019-80139
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• 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
• Date Manufacturer Received: 03/12/2019
• 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
• Patient Outcome(s): Death