MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X27IN 3-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP784D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Title: hand-sewn gastrojejunal anastomosis reduces delayed gastric emptying after pancreaticoduodenectomy: a single-center retrospective clinical study of 1,077 consecutive patients.The aim of this study was to identify factors that influence delayed gastric emptying after pancreaticoduodenectomy and assess the impact of different anastomotic methods on delayed gastric emptying.The study included 1,077 patients who had undergone either hand-sewn anastomosis (n = 734) or stapled anastomosis (n = 343) during pancreaticoduodenectomy between december 2016 and november 2021 at our department.Two methods, ha and sa, were used by the pancreatic surgery center of changhai hospital of the chinese pla during gastrojejunal / duodenojejunal anastomosis.A 75-mm linear cutter (tlc75) was used to transect the distal stomach (approximately 60% of the stomach remained)/proximal duodenum.The ha technique involved the following steps: second, full-layer anastomosis was performed using a continuous lock stitch, in which an absorbable 3-0 suture (vcp7840) was used (figure 1, b).Finally, the seromuscular layer was reinforced with 3-0 sutures (vcp784d) along the anastomosis (figure 1, c).In sa, the gastric cavity was opened along with the closed edge of the gastric stump prepared for passing an anvil rod of a curved intraluminal stapler (ethicon endo-surgery, cdh25a), and then end-to-side antecolic anastomosis of the residual posterior gastric wall near the greater curvature and distal jejunum was conducted the reported complications included delayed gastric emptying; a, b, & c (n=95), bile leakage (n=9), intra-abdominal infection (n=193), upper gastrointestinal tract bleeding (n=23), postoperative pancreatectomy hemorrhage (n=27), and postoperative pancreatic fistula; biochemical leak, b & c (n=218).In conclusion, hand-sewn anastomosis was associated with a lower incidence rate of clinically relevant delayed gastric emptying after pancreaticoduodenectomy.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Citations: surgery 175 (2024) 1140- 1146.Https:/ /doi.Org/10.1016/j.Surg.2023.12.001.
Additional Manufacturer Narrative
Product complaint #(b)(4).Corrected information: b1, b2, h1 - additional information was received and it was reported that the event is not related to the device.Therefore, this medwatch report is being voided.

• Brand Name: VCL+ VIO 8X27IN 3-0 S/A SH CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21551696
• Report Number: 2210968-2025-02463
• Device Sequence Number: 8165158
• Product Code: GAM
• UDI-Device Identifier: 10705031055551
• UDI-Public: 10705031055551
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: VCP784D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown