MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Failure to Anastomose (1028); Abscess (1690); Hemorrhage/Bleeding (1888); Paresis (1998); Post Operative Wound Infection (2446)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # : (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 single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Non-death cases ( lpd and opd groups): does the author/surgeon believe that ethicon product ( pds sutures and prolene sutures) involved caused and/or contributed to cases in both groups with post-op outcome ( anastomosis-related complication, delayed gastric emptying, chylous leakage, post-op pancreatic hemorrhage, wound infection, and intra-abdominal abscess) described in the article? does the surgeon believe there was any deficiency with the ethicon products (pds sutures and prolene sutures) used in both groups with post-op outcome ( anastomosis-related complication, delayed gastric emptying, chylous leakage, post-op pancreatic hemorrhage, wound infection, and intra-abdominal abscess)? were these cases with post-op outcome discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Please provide patient demographics for each case with post-op outcome ( anastomosis-related complication, delayed gastric emptying, chylous leakage, post-op pancreatic hemorrhage, wound infection, and intra-abdominal abscess)? citation: journal of laparoendoscopic & advanced surgical techniques, volume 30, number 5, 2020 mary ann liebert, inc.Doi: 10.1089/lap.2019.0695.Adverse events were submitted via 2210968-2021-06386.Death event was submitted via 2210968-2021-06383.

Event Description

Title: lessons learned from the introduction of laparoscopic pancreaticoduodenectomy this study aimed to describe the experience and a stepwise technical implementation of the laparoscopic pancreaticoduodenectomy (lpd) during early introduction in 2016.A team of three hepatopancreaticobiliary surgeons with extensive experience in open pancreaticoduodenectomy (opd) and with advanced laparoscopic skills started a proctor-guided program with lpd.Opd was done through a bilateral subcostal incision.The pancreas was divided with a knife, and hemostasis was achieved with prolene 5-0 stitches.The 3 and 9 o¿clock arteries of the hepatic duct were oversewn with prolene 5-0.A billroth-ii reconstruction with a dunking, end-to-side pancreaticojejunostomy was created at the beginning of the jejunal limb (running prolene 3-0) followed by an end-to-side hepaticojejunostomy (running pds 4-0 for ducts >8 mm; interrupted pds 5-0 for ductsp8mm) and an end-to-side duodenojejunostomy (running pds 3-0) in case of a pylorus-preserving technique or a side-to-side gastrojejunostomy (running pds 3-0) for a classic whipple¿s resection.All staple lines were oversewn with pds 4-0.Portal and superior mesenteric vein branches as well as the gastroduodenal artery and inferior pancreaticoduodenal artery stumps were clipped and oversewn with prolene 4-0.Routinely, two silicon drains were left behind: one behind the hepaticojejunostomy and the other behind the pancreaticojejunostomy.After a 30 minute break, the primary and assisting surgeon switched, and the anastomoses were created.A billroth-ii reconstruction was used in all cases.First, hepaticojejunostomy was performed with a running pds 4-0 for bile ducts >8mm and with interrupted pds 5-0 for bile ducts p8mm.Second, pancreaticojejunostomy was performed with a dunking technique similar to the open technique using v-loc3-0 sutures (medtronic).Finally, a stapled side-to-side gastroenterostomy was created with echelon flex, the remaining defect was closed with v-loc 3-0.Two silicon intra-abdominal drains were left behind identical to the open technique.After 10 lpd cases, we evaluated the results and discussed these with an international expert.We decided to switch to a hybrid technique with an lpd and open reconstruction (lpd-or) through a small (7 cm) upper midline incision.The last 10 cases were done using the lpd-or technique.The resection phase was identical to the lpd, and the reconstruction phase was identical to the opd.After consulting an international lpd expert, the team switched to a hybrid technique consisting of lpd followed by open reconstruction through midline minilaparotomy (lpd-or).In the following 10 cases of lpd-or, no anastomosis-related complications did occur (p =.342 opd versus lpd-or).Reported postoperative complication in the opd group included anastomosis-related complication (n=11), delayed gastric emptying (n=25), chylous leakage (n=20), post-op pancreatic hemorrhage (n=3), wound infection (n=1), and intra-abdominal abscess (n=3).Reported postoperative complication in the lpd group included anastomosis-related complication (n=7), delayed gastric emptying (n=4), chylous leakage (n=4), post-op pancreatic hemorrhage (n=3), wound infection (n=1), and intra-abdominal abscess (n=1).In conclusion, safe introduction of new techniques in minimally invasive major abdominal surgery is imperative.Based on our single-center experience, lpd-or may be safer in the earliest phase of the learning curve of minimally invasive pd, as part of a stepwise implementation toward the fully laparoscopic technique.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• 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
• MDR Report Key: 12177683
• MDR Text Key: 267671435
• Report Number: 2210968-2021-06385
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2021

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: 07/05/2021
• Initial Date FDA Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1