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

Catalog Number	5955680
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 2 years 2 months post implant of ventralight st w/ echo, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This emdr represents the ventralight st w/ echo (device #2).An additional supplemental emdr was submitted to represent the ventrio mesh (device #1).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.Not returned.
Event or Problem Description
Per information provided: (b)(6) 2013 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, ¿the hernia was identified just to the right of the midline.A ventrio hernia patch (device#1) was then placed intraabdominally using sutures.¿(b)(6) 2015 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st using echo ps (device #2) and removal of ventrio mesh (device #1).Per operative notes, ¿the adhesions were taken down from the anterior abdominal wall.The ventrio mesh (device #1) was loose and curled up and this ventrio mesh (device #1) was removed.Then a ventralight st using echo ps (device #2) was placed into the abdomen using tackers.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st using echo ps (device #3).Per operative notes, ¿the lower edge of the old mesh (device #2) had tented up into the hernia.The adhesions were lysed, then an another ventralight st using echo ps mesh (device #3) was used for repair and secured by tackers.¿ attorney alleges that the patient had adhesions, mesh migration, mesh shrinkage, pain, hernia recurrence and emotional injuries.It is also alleged that the patient had additional surgery to remove the mesh and repair the hemia, permanent and severe scarring and disfigurement.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 2 years 2 months post implant of ventralight st w/ echo, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.Addendum: this supplemental emdr is submitted to document the dhr results and to update annex a code.Review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: b4, g3, g6, h2, h4 (manufacturing date), h6, h10.This supplemental emdr represents ventralight st w/ echo (device #2).An additional supplemental emdr was submitted to represent the ventrio mesh (device #1).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.
Event or Problem Description
Per information provided: (b)(6) 2013 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, ¿the hernia was identified just to the right of the midline.A ventrio hernia patch (device#1) was then placed intraabdominally using sutures.(b)(6) 2015 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st using echo ps (device #2) and removal of ventrio mesh (device #1).Per operative notes, ¿the adhesions were taken down from the anterior abdominal wall.The ventrio mesh (device #1) was loose and curled up and this ventrio mesh (device #1) was removed.Then a ventralight st using echo ps (device #2) was placed into the abdomen using tackers.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st using echo ps (device #3).Per operative notes, ¿the lower edge of the old mesh (device #2) had tented up into the hernia.The adhesions were lysed, then an another ventralight st using echo ps mesh (device #3) was used for repair and secured by tackers.¿ attorney alleges that the patient had adhesions, mesh migration, mesh shrinkage, pain, hernia recurrence and emotional injuries.It is also alleged that the patient had additional surgery to remove the mesh and repair the hemia, permanent and severe scarring and disfigurement.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: 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: 20492478
• Report Number: 1213643-2024-094764
• Device Sequence Number: 4174384
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(17)170328(10)HUZC0154
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2017
• Device Catalogue Number: 5955680
• Device Lot Number: HUZC0154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 112 KG