MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX; SURGICAL MESH

Catalog Number UNKAA077

Device Problem Migration (4003)

Patient Problems Erosion (1750); Obstruction/Occlusion (2422)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information extracted from the article, we are unable to determine to what extent, if any, the davol device may have caused or contributed to the patient's postoperative course.At this time no conclusion can be made.A lot number was not provided, as such a review of the manufacturing records cannot be conducted.Should additional information be provided, a supplemental emdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.

Event Description

The following was reported via journal article (hernia, aug.2018, vol.22 issue 4): title: bowel obstruction secondary to migration of a ventralex mesh: report of a rare complication.Based on the article the patient was treated for a parastomal hernia with intraperitoneal placement of a goretex mesh.Approximately, one year after surgery, he was diagnosed with a small periumbilical incisional hernia.The patient underwent repair with the implantation of a ventralex hernia patch.At six months postoperative he experienced an episode of complete small bowel obstruction which was managed conservatively.The diagnosis of obstructive ileus was established by ct scan and the clinical suspicion of incisional hernia recurrence was verified.Thereafter, he was suffering from bowel obstruction almost once every 2 months.A ct scan revealed recurrence of incisional hernia and small bowel obstruction.The patient underwent a procedure for which extensive adhesiolysis between jejunal loops and the inferior surface of the goretex mesh and the anterior abdominal wall was performed.The mesh (gortex) was excised.During exploration of the peritoneal cavity, they palpated a mobile intraluminal mass in the proximity of splenic flexure.With gradual squeezing of the wall of the colon, they managed to propel out a foreign body through the permanent stoma that was proved to be the ventralex hernia patch (explanted).There was no thickening of the wall of the colon nor were there any signs of fistula between colonic segments and the anterior abdominal wall or the small bowel.The patient was discharged on the fifth postoperative day and 17 months thereafter, he remains in good health.

Manufacturer Narrative

This is an addendum to document additional information provided in follow up.Note the implant date, explant date, and date of event are estimated, as only the implant (2012) and explant (2015) years were provided.Should additional information be provided, a supplemental emdr will be submitted.

Event Description

The following was reported via journal article (hernia, aug.2018, vol.22 issue 4): title: bowel obstruction secondary to migration of a ventralex mesh: report of a rare complication.Based on the article the patient was treated for a parastomal hernia with intraperitoneal placement of a goretex mesh.Approximately, one year after surgery, he was diagnosed with a small periumbilical incisional hernia.The patient underwent repair with the implantation of a ventralex hernia patch.At six months postoperative he experienced an episode of complete small bowel obstruction which was managed conservatively.The diagnosis of obstructive ileus was established by ct scan and the clinical suspicion of incisional hernia recurrence was verified.Thereafter, he was suffering from bowel obstruction almost once every 2 months.A ct scan revealed recurrence of incisional hernia and small bowel obstruction.The patient underwent a procedure for which extensive adhesiolysis between jejunal loops and the inferior surface of the goretex mesh and the anterior abdominal wall was performed.The mesh (gortex) was excised.During exploration of the peritoneal cavity, they palpated a mobile intraluminal mass in the proximity of splenic flexure.With gradual squeezing of the wall of the colon, they managed to propel out a foreign body through the permanent stoma that was proved to be the ventralex hernia patch (explanted).There was no thickening of the wall of the colon nor were there any signs of fistula between colonic segments and the anterior abdominal wall or the small bowel.The patient was discharged on the fifth postoperative day and 17 months thereafter, he remains in good health.

• Brand Name: MESH - VENTRALEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7804609
• MDR Text Key: 117852330
• Report Number: 1213643-2018-02859
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR