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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Fistula (1862); Unspecified Infection (1930); Obstruction/Occlusion (2422); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).

Event Description

It was reported via journal article, ¿use of negative pressure wound therapy in the management of infected abdominal wounds containing mesh: an analysis of outcomes¿ that a study was conducted to document the outcomes of using negative pressure wound therapy (npwt) as an adjunctive treatment for abdominal wound infections with exposed mesh.For each patient, total hospital length of stay (los), complications and procedures performed were documented prior to and post-npwt initiation to determine efficacy of npwt in the treatment of this type of wound.A non-randomized, retrospective review of medical records for 21 consecutive patients with infected abdominal wounds treated with npwt was conducted.Inclusion criteria into the study were patients with a primary diagnosis of infected abdominal wound with exposed mesh following a failed acute abdominal wall closure or ventral hernia repair from 1999 to 2004.Wounds were classified into 3 different groups according to type of mesh used: pp mesh (marlex, bard vascular; n=8), knitted pg mesh, and a pp/expanded polytetrafluoroethylene composite mesh (bard composix; n=8).Twenty-one patients (6 men, 15 women; mean age 71 years [range 36-87]) with abdominal wounds with exposed, infected mesh were treated with npwt.Among patients with pg mesh, all were hypoalbuminemic with wounds secondary to acute abdominal closure and intra-operative polymicrobial cultures (mrsa and p.Aeruginosa).All pg meshes were left in situ and all subsequently healed.Complications pre-npwt and post-npwt include: fistula (pre: n=5; post: n=1 [pp mesh]), small bowel obstruction (pre: n=3; post: n=0), abscess (pre: n=12; post: n=1), sinus tracts (pre: n=4; post: n=3 [composite mesh]).Prior to initiation of npwt and associated mesh extraction and debridements, 5 patients were treated for fistula, 14 were admitted for drainage of abscesses for a total of 20 such admissions, 4 for sinus tracts and 3 for small bowel obstruction.Following initiation of npwt, three, 3 patients with retained composite mesh were treated for sinus tracts, 2 abscesses developed requiring incision and drainage, and 1 patient with retained pp mesh was treated for an enterocutaneous fistula.The results suggest a reduction in the number of complications with the use of npwt versus standard care.

• 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 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7149286
• MDR Text Key: 95867138
• Report Number: 2210968-2017-71989
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/27/2017
• 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