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

Catalog Number 0010302

Device Problem Hole In Material (1293)

Patient Problems Purulent Discharge (1812); Fistula (1862); Inflammation (1932)

Event Date 03/11/2017

Event Type  Injury  

Manufacturer Narrative

The explanted sample was returned for evaluation. Visual examination of the sample confirmed that there was physical damage to the polypropylene mesh side of the device. The polypropylene fibers indicate the material has been recently cut and most likely occurred during resection of the device during the explant procedure. There was an area of material deformation and holes in the center area of the eptfe layer. The center areas of the eptfe layer where the holes are noted appear to have coincided with the report of small intestine possibly adhered to or in contact with this area of the device. The holes that are present also appear to be new and most likely presented when bowel was removed from this area of the device. Based on review it is highly likely that the damage that is identified at this time happened during the revision procedure when the mesh was explanted. A review of the manufacturing records was performed and found that the lot was manufactured to specification with no materials or manufacturing anomalies identified. To date, this is the only reported complaint for this lot of (b)(4) units released for distribution on 04/24/2008. Fistula formation and inflammation are known possible complications and are identified in the adverse reaction section of the instructions-for-use. At this time no definitive conclusions can be made as to the cause of the patient¿s post-op complications. The degree to which the device may have caused or contributed is undeterminable. 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.

Event Description

It was reported that in 2008 the patient was treated for an incarcerated umbilical hernia and was implanted with a bard ventralex hernia patch. In (b)(6) 2017 the patient was hospitalized and diagnosed with an abdominal wall phlegmon. On (b)(6) 2017 the patient underwent an open ipom procedure. During this procedure the ventralex hernia patch was explanted. Surgeon reported that a hole was noted in the eptfe layer of patch upon explant. An intestinal fistula bearing small intestine sling were resected (15cm of small intestine in total). Anastomosis was performed and the abdominal wall was closed with simple interrupted sutures. As reported the patient is doing well, eating and drinking. Device was returned for evaluation.

• 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
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6475081
• MDR Text Key: 72191299
• Report Number: 1213643-2017-00222
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)130428(10)HUSC1821
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2013
• Device Catalogue Number: 0010302
• Device Lot Number: HUSC1821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/10/2017 Patient Sequence Number: 1