MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number PVPUNK

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Inflammation (1932); Nausea (1970); Obstruction/Occlusion (2422); Not Applicable (3189); No Code Available (3191)

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: j innov cardiac rhythm manage.2019;10(4):3593¿3599.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 product (proceed ventral patch) 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 product involved? 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: an intense inflammatory reaction to a proceed ventral patch.The aim of this study is to present an unusual case of an intense reaction to a proceed ventral hernia patch, causing an ileus and partial erosion of the mesh into the serosa of the small bowel.A(b)(6) male presented with recurrent bilateral inguinal hernias and an incidental umbilical hernia discovered on physical examination.The patient underwent a successful bilateral inguinal hernia repair with a single 28x10 cm ultrapro mesh.For the umbilical hernia, the polyester tails were cut off the proceed patch (ethicon) and replaced with a single prolene suture.The 4.3cm patch was rolled up and introduced through the hernia site.The umbilical hernia was repaired by primary closure of the fascial defect and the patch pulled up with the prolene suture.The patch was secured with a combination of absorbable and nonabsorbable tacks related to what was left over after the bilateral inguinal hernia repairs on postoperative day 8, the patient reported some nausea that was treated symptomatically and subsequently developed severe abdominal pain on postoperative day 12, so a computed tomography (ct) abdomen was performed and revealed high-grade small bowel obstruction at the level of the umbilicus with a transition point at the level of the mesh but without evidence of a recurrent hernia.Forty-eight hours of nasogastric suction failed to resolve the obstruction completely, and therefore, the decision was made to return to the operating room on postoperative day 17.Generalized exploration of the abdomen disclosed an inflammatory process involving the small bowel to the area of the proceed hernia patch.They began taking down the adhesions of the mesh and ultimately were able to expose an area where there was a densely adherent tack, which appeared to almost be eroding into the bowel.The offending tack was removed and they have elected to remove the entire prosthesis as well as the tacks because they felt this intense inflammatory reaction might be an allergic phenomenon.The hernia was repaired primarily using running 0 polydioxanone film.The patient had an uneventful postoperative course after this revision with resolution of abdominal pain and bowel obstruction.He was discharged home and returned to clinic for follow-up without any complications.Newer patches, such are convenient, easy to use, and reduce operating time, thus making them popular among surgeons repairing small hernia defects.However, with the addition of the positioning straps, reinforcing rings, and adhesion barriers, these patches are much bulkier and appear to function differently compared with a flat prosthesis with a simple antiadhesion coating barrier.A literature search of these new patches discloses numerous reports supporting the claim of increased complications.

• Brand Name: PROCEED VENTRAL PATCH 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; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10624020
• MDR Text Key: 209798334
• Report Number: 2210968-2020-07601
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2020

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
• Device Catalogue Number: PVPUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 10/02/2020
• 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): Required Intervention
• Patient Age: 66 YR