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

Catalog Number 5954680

Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Hernia (2240); Disability (2371)

Event Date 08/07/2014

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.Based on the information provided, it is alleged the patient experienced material deformation, folded mesh and adhesions.Adhesions is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.Without the device sample returned for evaluation, the allegation of material deformation and folded mesh can not be assessed at this time.If additional event and/or evaluation information is obtained, a follow up 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.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2011 - the patient underwent surgery for repair of ventral incisional hernia, a ventralex hernia patch was implanted to repair the hernia defect.(b)(6) 2014 - the patient underwent an additional surgery when a ct scan revealed the mesh had contracted and folded.(b)(6) 2015 - the patient had to undergo another procedure for repair of the folded mesh and multiple adhesions adherent to the mesh.The attorney alleges the patient has suffered and will continue to suffer physical pain and was severely and permanently injured.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2011 - the patient underwent surgery for repair of ventral incisional hernia, a ventralex hernia patch was implanted to repair the hernia defect.(b)(6) 2014 - the patient underwent an additional surgery when a ct scan revealed the mesh had contracted and folded.(b)(6) 2015 - the patient had to undergo another procedure for repair of the folded mesh and multiple adhesions adherent to the mesh.The attorney alleges the patient has suffered and will continue to suffer physical pain and was severely and permanently injured.Addendum per additional information provided: (b)(6) 2011 - patient was diagnosed with ventral incisional hernias thereby underwent open repair with ventralight st mesh.Per the operative notes, ¿the hernias were repaired using a single piece of ventralight st mesh and sutured.¿ (b)(6) 2011 - the patient had lower abdominal pain and underwent colonoscopy.(b)(6) 2014 - patient was developed with abdominal pain thereby underwent laparoscopic repair of recurrent ventral hernia.Per the operative notes, " there were dense adhesions to the abdominal wall and were taken down.A recurrent small ventral hernia in the left lower side of the mesh was freed.The mesh was noted to be folded in the left lower quadrant and left upper quadrant.Placed tacks and sutures in several areas of the mesh to unfold the mesh completely.¿ (b)(6) 2015 - patient developed with recurrent abdominal pain and underwent laparoscopic lysis of adhesions, fixation of the inferior aspect of the mesh.Per the operative notes, "multiple adhesions to the previous mesh were taken down.Sutures were placed to good fixation of the folded inferior aspect of the right mesh.The rest of the mesh was well expanded without evidence of recurrent hernia." attorney alleges that the patient had adhesions, hernia recurrence, folded mesh, lack of incorporation, herniated omentum, pain and emotional injuries.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.Based on the information provided, it is alleged the patient experienced material deformation, folded mesh and adhesions.Adhesions is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.Without the device sample returned for evaluation, the allegation of material deformation and folded mesh can not be assessed at this time.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: h11: this supplemental mdr is submitted to document additional information provided and to correct product identifiers.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, post implant of ventralight st mesh, patient was diagnosed with abdominal pain, mesh deformation, hernia recurrence and adhesions thereby underwent revision surgeries.The adverse reactions section of the instructions-for-use (ifu) supplied with the device list hernia recurrence and adhesions as possible complications.Updated fields: a2, a4, b4, b5, b6, b7, e3, g1, g3, g6, h2, h3, h6, h10, h11 corrected fields: d1, d4 (product catalog no., corporate lot no, expiry date, udi no.), g4 (pma/510(k) #) note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.

• Brand Name: VENTRALIGHT ST MESH
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 7043227
• MDR Text Key: 92467326
• Report Number: 1213643-2017-00891
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2023

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: 02/28/2013
• Device Catalogue Number: 5954680
• Device Lot Number: HUVB0827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/29/2023
• 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): Disability; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 84 KG