MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST

Catalog Number 5950009

Device Problem Folded (2630)

Patient Problem Adhesion(s) (1695)

Event Date 11/14/2014

Event Type  Injury  

Event Description

The following was reported to davol: (b)(6) 2014 - patient was implanted with a bard/davol ventralex st hernia patch for repair of an umbilical hernia.As reported tacks were placed through the pockets and around the perimeter of the mesh.On (b)(6) 2014 - patient underwent video assisted laparoscopic revision procedure, with explant of the bard/davol ventralex st hernia patch.As reported, adhesions were found on the parietal part of the implant, as part of the patch had folded over toward the viscera.

Manufacturer Narrative

As reported the device had been implanted two days prior to explant.The device was returned to davol for evaluation.All components were found to be completely intact.There were some small bends/folds in the recoil ring and there was also some tissue attached to the mesh side of the patch.There are a number of factors that can cause or contribute to the problem reported, such as greater than normal stresses placed on the patch during preparation for deployment, during deployment and positioning, greater than normal stresses placed on the patch over the period of implant, as well as the need to properly place and fixate the device by the user, or a combination of these factors.A review of the manufacturing records shows that the lot was manufactured with no anomalies.There is no evidence that would indicate this to be a manufacturing related issue.

• Brand Name: VENTRALEX ST
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, rd #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4346141
• MDR Text Key: 21171924
• Report Number: 1213643-2014-00447
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2014

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 Expiration Date: 02/28/2015
• Device Catalogue Number: 5950009
• Device Lot Number: HUXB0887
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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: 59 YR