MAUDE Adverse Event Report: ETHICON INC. ETHISORB DURA-PATCH; DURA SUBSTITUTE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Unspecified Nervous System Problem (4426)

Event Date 10/30/2021

Event Type  Injury  

Event Description

Title: function and composition of pancreatic islet cell implants in omentum of type 1 diabetes patients.This study reports on function and composition of omental (om) implants after placement of islet cell grafts with similar beta cell mass as in our ip-protocol (2¿5.106 beta cells/kg body weight) on a scaffold.Cultured islet cell grafts were laparoscopically implanted in the omentum using a scaffold that was varied in search of a condition with minimal cell loss during injection and with appearance of plasma c-peptide levels during the first post-transplant (pt)-weeks.In five patients the graft was placed on a degradable support which consisted of eithe synthetic polyglactin on polydioxanone-pdxn mesh (ethisorb¿ dura patch, ethicon; case 3) or only polyglactin (vicryl®, ethicon).Reported complications included amorphous material surrounded by cd68+cell accumulations, a characteristic of foreign body reaction , activation to gad was detected post-ip in cases 3 and 4 in which gad-ab- titer had increased post-om.In conclusion study can serve as reference for further clinical studies that seek conditions for improving survival and function of islet cell om-implants in type 1 diabetes patients.Candidates for a therapeutic ip-implant agreed to first participate in a pilot that examined efficacy of an om-implant and that, in case of inadequate function, would be followed by an additional ip-injection as in the standard ip-protocol.The omental implant did not impair outcome of a subsequent ip-implant, on the contrary.According to hgc-tests 6 months post-ip, the fbm was higher than that in patients without prior om-implant.This better outcome might be attributed to a longer state of immune suppression and lymphopenia.One om-patient lost function of his ip-implant within two months, after seroconverting to gad-positivity; he had a cellular autoreactivity to ia2 since start.No correlations were found between donor-specific hla-antibodies and implant function.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 c.F.R, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2023-02746.Citation: am j transplant.2022;22:927¿936.Doi: 10.1111/ajt.16884 please see article attached.

• Brand Name: ETHISORB DURA-PATCH
• Type of Device: DURA SUBSTITUTE
• 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: 16751446
• MDR Text Key: 313410634
• Report Number: 2210968-2023-02745
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other