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

Catalog Number	5955460
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	08/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device #1).Per operative notes, ¿loop of bowel adherent was reduced and freed from hernia.The bowel appeared to be intact.A ventralight st mesh using echo ps (device #1) was placed into the abdomen and tacked.¿ (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralex st mesh (device #2).Per operative notes, ¿the hernia sac was opened.There was some bowel adhesed up to the lateral inferior aspect where the mesh was placed.Ventralight st mesh using echo ps (device #1) was not removed as it was found to be intact and well incorporated.A ventralex st mesh (device #2) was placed into the abdomen and sutured.¿ (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralight st mesh (device #3).Per operative notes, ¿dissection was carried down to the mesh and freed up the anterior aspect of the upper portion of the mesh.Hernias were identified.Mesh was completely freed up and then got into the abdomen.The small bowel was completely reduced and adhesions up to the anterior abdominal wall were taken down.Prior mesh was not removed as it was well incorporated and used that as the lower portion of repair.Vest-over-pants technique was used.A ventralight st mesh (device #3) was used for repair and sutured.¿ attorney alleges that the patient had adhesions, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical record review, about 4 months post implant of ventralight st mesh using echo ps, patient was diagnosed with adhesions and hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device lists adhesions and hernia recurrence as possible complications.This emdr represents the ventralight st w/ echo (device #1).An additional supplemental emdr was submitted to represent the ventralex st (device #2).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.

• 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: 18786313
• Report Number: 1213643-2024-090869
• Device Sequence Number: 8352185
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2024

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: 11/28/2017
• Device Catalogue Number: 5955460
• Device Lot Number: HUZJ0334
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 136 KG