MAUDE Adverse Event Report: ETHICON INC. VYPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Date 07/27/2020

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 regarding the additional events.  citation: european urology 78 (2020) 757¿763.Https://doi.Org/10.1016/j.Eururo.2020.07.033.Please see article attached.  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? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon product (vypro mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved?.

Event Description

It was reported in a journal article with title: preventing parastomal hernia after ileal conduit by the use of a prophylactic mesh: a randomised study.The authors performed a prospective randomised multicentre study to ascertain whether the use of a prophylactic mesh can decrease the risk of developing clinical parastomal hernia (psh).From 2012 to 2017, a total of 241 patients scheduled to undergo open radical cystectomy for bladder cancer and ileal conduit were randomised 1:1 to prophylactic mesh implantation or conventional stoma formation.In the no mesh group/control arm, 123 patients (97 male and 26 female; age, median (iqr): (b)(6) years; bmi, median (iqr): 26 (24-28)) had no prophylactic mesh, and in the mesh group/intervention arm, 118 patients (91 male and 27 female; age, median (iqr): 71 (65-74) years; bmi, median (iqr): 26 (22-28)) had a prophylactic mesh.Preoperatively in the mesh group, the stoma location was marked on the skin by a stoma nurse within the area of the right rectus abdominis muscle, except in one (b)(6) hospital where it was performed by the operating urologist.A vypro mesh (10 cm x 10 cm; ethicon) was used.Reported complications in the mesh group/intervention arm included clinical psh at 6 months (n-1), clinical psh at 12 months (n-7), clinical psh at 24 months (n-10), clinical psh at the end of the follow up (n-12), radiological psh within 24 months (n-17), radiological psh iii at the end of the follow up (n-7), radiological psh i-ii at the end of the follow up (n-9) in which 2 patients were operated for psh.One of the patients operated for a psh in the control arm received a sublay lightweight mesh at surgical repair, and that patient suffered from erosion of the mesh into the conduit, which required a surgical revision.The use of a prophylactic lightweight mesh reduces the risk of psh after ileal conduit construction without causing any mesh-related complications, although with a prolonged operating time.

• Brand Name: VYPRO 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): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11536383
• MDR Text Key: 255340080
• Report Number: 2210968-2021-02584
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K002672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• 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