MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC

Catalog Number PROCEEDMUNK

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

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: the american surgeon (2014); 80: 489-495. 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 ethicon products (proceed mesh, ultrapro mesh, prolene mesh, prolene suture, and pds ii suture) 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? (b)(4).

Event Description

It was reported in a journal article with title: noncrosslinked porcine-derived acellular dermal matrix for single-stage complex abdominal wall herniorrhaphy after removal of infected synthetic mesh: a retrospective review. The objective of this retrospective case review was to assess outcomes after surgery in patients who had a recurrent, complex incisional hernia associated with previously placed, infected synthetic mesh and underwent single-stage incisional herniorrhaphy using reinforcement with porcine-derived acellular dermal matrix (padm). Between 2009 and 2011, a total of 13 patients (n=5 male and n=8 female; mean age of 60±13 years [ranged 38-79 years]; mean bmi of 35. 6±10. 8 years [ranged 26-65]) with grade 4 infected synthetic mesh underwent single-stage complex abdominal wall herniorrhaphy after removal of infected synthetic mesh. Of the 13 patients, prolene mesh (n=3), prolene mesh + gore-tex (n=1), prolene mesh + ultrapro mesh (n=1) and proceed mesh (n=1) were removed during the surgery. In the operation, herniorrhaphy was performed using #1 prolene or pds sutures, and was also used to secure padm. Blake drains (size 19 french) were placed in all patients, except two who had vacuum-assisted closure placed on an open wound. All patients received antibiotic regimens initiated before surgery and adjusted postoperatively as needed based on culture results. Vancomycin, piperacillin/tazobactam, and ertapenem were the most commonly administered perioperative antibiotics. Postoperative complications included wound infection (n=1) that was drained surgically without removal of the padm, and seroma (n=1) that resolved without intervention. The encouraging results with regard to postoperative infection and recurrence rates seen here and previously for herniorrhaphy with a biologic matrix may be related to the inherent scaffold like properties of biologic matrices, which encourage growth of native tissue into the matrix. Perhaps because biologic matrices permit cellular and vascular infiltration into the prosthesis, greater resistance to and clearance of pathogens versus synthetic mesh may be possible.

• Brand Name: PROCEED MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8907304
• MDR Text Key: 154774124
• Report Number: 2210968-2019-85754
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• 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: 07/25/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/19/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: PROCEEDMUNK
• 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: 07/25/2019
• 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: 08/19/2019 Patient Sequence Number: 1