MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

Catalog Number VICRYLMSHUNK

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4). Date sent to the fda: 2/24/2021. (b)(4). Adverse events will be submitted via 2210968-2021-01782, 2210968-2021-01784, and 2210968-2021-01785. 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.   citation: case reports in surgery volume 2020, article id 4716415, 5 pages doi: https://doi. Org/10. 1155/2020/4716415.   additional information was requested and the following was obtained:   were the cases discussed in this article previously reported ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that the ethicon products (vicryl 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 products involved? this case report is to show our experience with bridging vicryl mesh in transplant patients with inability to close the abdomen primarily due to large graft size(large transplanted liver ). The case report mentioned bellow shows a positive outcome with the use of vicryl mesh ,there was no complications from mesh used and in fact the last quote of the article confirms the utility of such mesh in these patients : "our case series successfully show that utilizing a bridging vicryl knitted mesh is a reasonable approach to attain tension-free abdominal closure in olt with satisfying results. "not sure what complaints are you referring to, please let me know who complained and about what exactly. There was no complications from mesh used. This case series is to show our experience with bridging vicryl mesh, which was very positive in transplant patients with inability to close the abdomen due to large graft size. Not sure what complaints are you referring to. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported in a journal article with title: utilization of vicryl bridging mesh in orthotopic liver transplantation to achieve tension-free abdominal wall closure: a case series. The aim of this case series is to present four cases of patients who underwent orthotopic liver transplantation (olt) with bridging vicryl knitted mesh (ethicon) to relieve the tension during the closure. Abdominal closure utilizes a bridging vicryl knitted mesh vkml (ethicon) to salvage the larger-sized grafts. The mesh is utilized in bridging fashion, was cut into an ellipse, and use 2 layers of the mesh to enforce it. Subsequently, the mesh is sutured to the external oblique muscle in the right subcostal incision area using a number 1 polydioxanone suture in a running fashion. Patient 3 is a (b)(6) year-old female patient with hepatic encephalopathy and ascites requiring paracentesis. She received a deceased donor orthotopic liver transplant. A bridging vicryl knitted mesh (ethicon) was placed in the right lateral part of the chevron incision. On postoperative day 4, the level of her liver enzymes was acutely elevated, but liver ultrasound showed normal resistive indices. She was started on stress dose steroids for suspected acute cellular rejection. Postoperatively, she had hypotension requiring pressors for 48 hours, acute kidney injury, and ileus, all of which resolved by her discharge on postoperative day 10. She is currently five months postoperatively, and her liver enzymes remain within normal limits. Our case series successfully show that utilizing a bridging vicryl knitted mesh is a reasonable approach to attain tension-free abdominal closure in olt with satisfying results.

• Brand Name: VICRYL POLYGLACTIN 910 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; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11376779
• MDR Text Key: 240407502
• Report Number: 2210968-2021-01783
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL,LITERATUR

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/25/2021

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/24/2021
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: VICRYLMSHUNK
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/25/2021
• 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?

• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 02/24/2021 Patient Sequence Number: 1