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

Catalog Number 5950008

Device Problems Folded (2630); Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)

Event Date 03/08/2016

Event Type  Injury  

Manufacturer Narrative

Based on the information available at this time, no definitive conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.Adhesion is a known inherent risk of the procedure and is listed in the ifu as a possible complication.Additionally, the mesh remains implanted and is therefore not available for evaluation.Based on the limited information provided, the cause of the alleged "tacoed" mesh is unclear at this time.If additional information is obtained, a supplemental mdr 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.Additionally, patient details are unobtainable due to the privacy laws in (b)(6).Device remains implanted.

Event Description

The following was reported to davol: it is reported that on (b)(6) 2016, the patient underwent open hernia repair surgery and was implanted with a ventralex st hernia patch.As reported prolene sutures were used to secure the mesh with four sutures placed "inside the pocket." there was no trauma experienced by the patient in the initial post operative period.On (b)(6) 2016 the patient returned to the or with a bowel obstruction and bowel was found to be twisted and adhered to the center of the ventralex st hernia patch.The bowel was taken down easily with a grasper and at that point a secondary piece of bowel was found to have adhered to the underside of the mesh as the mesh had "tacoed." the mesh was left implanted in the patient.

• Brand Name: VENTRALEX ST
• 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: 5532380
• MDR Text Key: 41370771
• Report Number: 1213643-2016-00124
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5950008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2016
• 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