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

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/25/2020

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: international journal of surgery 75 (2020) 47¿52, https://doi.Org/10.1016/j.Ijsu.2020.01.124.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 products (ultrapro mesh and vypro mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there were any deficiencies with the ethicon products involved? event related to vypro mesh reported via mw # 2210968-2021-02586.

Event Description

It was reported in a journal article with title: short-term outcome after ventral hernia repair using self-gripping mesh in sublay technique ¿ a retrospective cohort analysis.This retrospective study aimed to objectively evaluate the postoperative complication rate after ventral hernia repair in sublay technique and compare outcomes of self-gripping vs.Conventional sutured, non-self-gripping meshes.Between january 2011 and july 2018, 244 patients who received a ventral hernia repair (including incisional, umbilical or epigastric hernias) in rives-stoppa retromuscular mesh placement technique (sublay), were included in the study.There were 122 males and 122 females with a median age of (b)(6) years (iqr 54¿73); mean bmi was 29 kg/m2 (±5.76).Patients were grouped according to the utilized mesh.The self-gripping mesh group was composed of 127 patients who all received a competitor¿s self-gripping mesh.While the non-self-gripping mesh group was composed of 117 patients in which 22 of them received an ultrapro mesh (ethicon), 2 received a vypro mesh (ethicon) and the others received competitors¿ non-self-gripping meshes.In the non-self-gripping mesh group, a conventional mesh was placed using sublay technique over the posterior sheath of the abdominal rectus muscle and was fixated with nonabsorbable monofilament sutures.In the self-gripping mesh group, the mesh was placed over the closed posterior fascia but underneath the abdominal rectus and oblique muscles.Due to microhooks, placed onto the posterior lamina of rectus sheath, a fixation with additional sutures was unnecessary.The anterior fascia was closed using a slowly absorbable suture.Reported complications in the non-self-gripping mesh group include surgical site infections (n-5), surgical site occurrences (n-14) that included seroma (n-8) and hematoma formation (n-6), recurrent hernia during follow-up (n-3), ileus caused by entrapped small bowel (n-2), early fascial dehiscence (n-1).One or more postoperative complication-associated surgical interventions (n-11), with surgical site occurrence requiring procedural interventions (n-9) and revisional surgery for postoperative complications (n-7).It was concluded that in sublay ventral hernia repair, the use of self-gripping meshes is associated with a higher overall complication rate and an increased rate of complication-associated surgical interventions when compared to non-self-gripping mesh placements.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/30/2021.  additional information was requested and the following was obtained: 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 products (ultrapro mesh and vypro mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there were any deficiencies with the ethicon products involved? additional information received from the hcp via email: were the cases discussed in this article previously reported to ethicon? no if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon products (ultrapro mesh and vypro mesh) involved caused and/or contributed to the post-operative complications described in the article? no.Does the surgeon believe there were any deficiencies with the ethicon products involved? no.This report is being submitted pursuant to the provisions of 21 cfr, 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, or its employees that the report constitutes an admission that the product, ethicon, 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.Product complaint # (b)(4).Date sent to the fda: 4/30/2021.Corrected information: b1, h1: additional information was received that this device was not involved in the event.Therefore, this medwatch report will be voided.This report is being submitted pursuant to the provisions of 21 cfr, 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, or its employees that the report constitutes an admission that the product, ethicon, 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.

• Brand Name: ULTRAPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11536514
• MDR Text Key: 255340677
• Report Number: 2210968-2021-02585
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention