MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number 5955790

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Adhesion(s) (1695); Peritonitis (2252); Bowel Perforation (2668)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

The explanted sample was not returned to davol for evaluation, however, images of the implant and resected tissue were provided.The photo of the explanted implant show the device to be in three pieces.There were multiple metal fasteners embedded in the implant material, some in close proximity to each other.While no definitive conclusions can be made at this time, it is possible that the metal fasteners could act as anchor points for adhesions.The mesh does not appear to have attached tissue after being removed from the bowel, but the images of the resected tissue do show the presence of adhesion, indicating that the implant was in contact with the bowel as was reported.As reported by the user the bowel was perforated due to contact with the fasteners.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Adhesion is a known inherent risk of surgery and is listed in the adverse reaction section of the ifu as a possible complication.Based on the information provided and review of the images no definitive conclusions can be made.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.

Event Description

The following was reported to davol: on (b)(6) 2016 - the patient underwent a hernia repair procedure and was implanted with a bard ventralight st w/ echo hernia patch.A non bard/davol protack fixation device was used to fixate the mesh.During this procedure it was noted that the hernia sac contained intestine which was dissected and reduced back to the abdominal cavity.On (b)(6) 2016 - post operatively the patient experienced acute peritonitis and underwent an additional procedure.During this procedure the physician noted that part of the intestine was stuck to the implant and the intestine had been perforated by the protack fasteners.Both the patch and the fasteners were explanted.The bowel was resected and repaired.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 5785933
• MDR Text Key: 49288016
• Report Number: 1213643-2016-00316
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K122436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 5955790
• Device Lot Number: HUZF1656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 60 YR