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 Wound Dehiscence (1154); Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)

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 clarify 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 author/surgeon believe that ethicon products (ethibond suture, pds suture and prolene suture) involved caused and/or contributed to post-op complications (retching episodes (n=3), bowel obstruction (n=1), midgut volvulus from adhesion (n=1), pyloric obstruction (n=1), wound dehiscences (n=3), bowel adhesion obstruction and an incisional hernia (n=1), large transhiatal para-oesophageal hernia.(n=1)) described in the article? please specify.Does the author/surgeon believe there was any deficiency with the ethicon products (ethibond suture, pds suture and prolene suture) used for cases described in this study? if yes, please provide a complete patient demographics for patients with post-op complication (retching episodes (n=3), bowel obstruction (n=1), midgut volvulus from adhesion (n=1), pyloric obstruction (n=1) , wound dehiscences (n=3), bowel adhesion obstruction and an incisional hernia (n=1), large transhiatal para-oesophageal hernia.(n=1))? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: (jpgn 2020;70: 457¿461),doi: 10.1097/mpg.0000000000002626 https://doi.Org/10.1007/s10151-020-02199-5.Events were submitted via 2210968-2021-08557 and 2210968-2021-08559.

Event Description

Title: total oesophagogastric dissociation in neurologically impaired children: 18 years¿ experience and long-term follow-up thirty patients (18 boys) who underwent togd between 2000 and 2018 in 2 italian centres were retrospectively reviewed.Twenty-three were primary procedures and 7 were ¿¿rescue¿¿ ones.Inclusion criteria were severe neurodisability, intractable gastroesophageal reflux, and dysphagia.Surgery was carried out in both centres by the same experienced surgeon, using a modified bianchi technique.Laparotomy was undertaken via a supraumbilical midline abdominal incision, with retraction of the left lobe of the liver for access to the oesophageal hiatus and the oesophagogastric junction.Any residual fundoplication (3/7, 43%) was taken down and the distal oesophagus isolated, preserving the left vagus nerve whenever possible.The oesophagus was detached from the stomach and the latter over-sewn.A vascularized 30 cm isoperistaltic jejunal roux loop, measured along the antimesenteric border and based on the first vascular arch, was raised distal to the ligament of treitz and intestinal continuity established by end-to-side jejunojejunal anastomosis at the 30 cm mark.The jejunal roux loop was passed through the transverse mesocolon and behind the stomach to reach the oesophagus.The proximal end of the jejunal loop was closed and a wide tension-free end-to-side anastomosis created between the distal oesophagus and the jejunal loop.All anastomoses were fashioned with 5/0-6/0 pds1 (ethicon#).Para-oesophageal herniae (3/7, 43%) were reduced and the oesophageal hiatus tightened with nonresorbable sutures (prolene1 or ethibond1¿ethicon#).Reported complications included retching episodes (n=3), bowel obstruction (n=1), midgut volvulus from adhesion (n=1), pyloric obstruction (n=1) , wound dehiscences (n=3), bowel adhesion obstruction and an incisional hernia (n=1), large transhiatal para-oesophageal hernia.(n=1).In conclusion togd is an effective procedure with an acceptably low complication rate for children with severe neurological impairment and is followed by a major improvement in general health and quality of life for children and families.There was no substantial difference in outcome between primary and ¿¿rescue¿¿ procedures.

• 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: 12484708
• MDR Text Key: 272256745
• Report Number: 2210968-2021-08536
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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?: No
• Date Manufacturer Received: 10/04/2021
• 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