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

Catalog Number 5950008

Device Problem Folded (2630)

Patient Problems Adhesion(s) (1695); Pain (1994); Impaired Healing (2378)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

As reported one month post implant the mesh was explanted.It is reported that the sample is being returned for evaluation; however has not been received to date.At this time no conclusions can be made.If/when the sample is returned a supplemental mdr will be submitted to document our findings.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 to davol that on (b)(6) 2016 the patient was implanted with a bard ventralex st hernia patch.Following implant it is reported that the patient developed a non healing, draining wound overlying the mesh with pain and overall fatigue.There was a concern for mesh infection.As reported on (b)(6) 2016 the patient was brought to surgery for a laparoscopic procedure.The mesh was found to have folded over with adhesions, including some to the bowel.The adhesions were released, with no injury to the bowel and the procedure was then transitioned to open and the mesh was removed.The defect was repaired with suture.

Manufacturer Narrative

Visual evaluation of the returned ventralex st found the sample to be folded with tissue attached on both sides.Half of the sample appears to have tissue ingrowth on the mesh layer.The pdo ring remains intact.Visual evaluation found no evidence of fixation.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the sample condition and available information, there is no way to definitively determine a cause for the reported conditions.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.

• 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: 6134649
• MDR Text Key: 61106653
• Report Number: 1213643-2016-00542
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

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: 04/30/2018
• Device Catalogue Number: 5950008
• Device Lot Number: HUAR0249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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: 32 YR