MAUDE Adverse Event Report: ETHICON INC. PROLENE 3D PATCH MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number 3DPROUNK

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

Patient Problems Erosion (1750); Perforation (2001); Hernia (2240); Unspecified Tissue Injury (4559)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Adverse events (death) submitted via mw# 2210968-2020-10172 and mw# 2210968-2020-10173.Adverse events (serious injury) submitted.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 regarding the additional events.Citation: f.De bie, e.Suply, t.Verbelen, et al., early surgical complications after congenital diaphragmatic hernia repair by thoracotomy vs.Laparotomy: a bic., journal of pediatric surgery doi: https://doi.Org/10.1016/j.Jpedsurg.2019.12.020.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.Were the cases discussed in this article previously reported to ethicon? does the surgeon believe that the ethicon products (3d prolene mesh, prolene suture) involved caused and/or contributed to the post-operative complication described in the article? does the surgeon believe there was any deficiency with the ethicon products (3d prolene mesh, prolene suture) used in this procedure? would the surgeon like to speak with ethicon medical and engineering?.

Event Description

It was reported in a journal article with title: early surgical complications after congenital diaphragmatic hernia repair by thoracotomy vs.Laparotomy: a bicentric comparison.This retrospective comparative cohort study aims was to evaluate the occurrence and nature of surgical reinterventions within the first year of life, following repair through thoracotomy as compared to laparotomy surgical strategy for congenital diaphragmatic hernia (cdh).Between 2000 and 2017, left-sided bochdalek-type cdh patient who underwent neonatal (<28 days of life) surgery during a 16-years period from 2000 (london) and 2001 (leuven) onwards were included in the study.They were operated with either postero-lateral thoracotomy (n=55) (male n=34/55, median ga at birth n=37.5 weeks and median birth weight n=2830 grams) at london or subcostal laparotomy (n=62) (male n=41/62, median ga at birth n=38.5 weeks and median birth weight n=3000 grams) at leuven.For the low left posterolateral thoracotomy, after manual reduction of abdominal organs, the diaphragmatic rim (if present) was dissected and the defect closed in a tension-free fashion, either using prolene 4/0 suture (ethicon) or with a gore dual mesh (non-ethicon).For the ipsilateral subcostal laparotomy, the diaphragm was either primarily sutured tension-free as above or reconstructed with a dacron polyethylene terephthalate mesh (non-ethicon) or a prolene® 3d patch polypropylene mesh (ethicon).During the first year of life, surgical reinterventions were reported in which more than half were due to acute gastrointestinal complications (clavien-dindo iiib & iv) (thoracotomy n=18.1% vs laparotomy n=6.5%).The thoracotomy group reported volvulus in the ileum (n=2), textiloma (n=1) and recurrence in patient with primarily sutured-repair of an ¿a¿ type defect (n=1).The volvulus required bowel resection or adhesiolysis and detorsion.Surgical removal was required for the textiloma and reoperation was performed for the recurrence.For the laparotomy group, perforation of duodenum (n=1), recurrence in patient with primarily sutured-repair of an ¿a¿ type defect (n=1), severe gerd issues (clavien-dindo iiib) (n=1), post-mortality within 1 year of age due to respiratory failure (n=3) and unspecified cause (n=1) were reported.Reoperation was performed for the recurrences and severe gerd issues.Postnatal cdh repair through thoracotomy was associated with a higher rate of surgical reinterventions within the first year of life, especially for severe acute gastro-intestinal complications.There seemed to be no difference in recurrence and mortality rate.

• Brand Name: PROLENE 3D PATCH MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): J-PAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11054496
• MDR Text Key: 223771061
• Report Number: 2210968-2020-10174
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K061533
• 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: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3DPROUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2020
• 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