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

Catalog Number	5955810
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	06/13/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st mesh (device #2).An emdr was submitted previously for bard flat mesh (device # 1; mdr number: 1213643-2018-00188 on 05-feb-2018).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol marlex mesh (bard flat mesh) and ventralight st on (b)(6) 2012 and/or (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient sustained injuries on (b)(6) 2012.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Note: the date of implant for ventralight st will be considered as (b)(6) 2012, since the initial legal claim identified the implant date for the marlex mesh (bard flat mesh) as (b)(6) 2012.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct sex of the patient and product details.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 2 years post implant of ventralight st w/ echo ps, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair with removal of the mesh.The instructions-for-use supplied with the device lists adhesions and hernia recurrence as possible complications.Review of the manufacturing records was performed and found that the lot was manufactured to specification.This supplemental emdr represents the bard/davol ventralight st w/ echo (device #2).An additional supplemental emdr was submitted to represent the bard flat 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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol marlex mesh (bard flat mesh) and ventralight st on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient sustained injuries on (b)(6) 2012.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Note: the date of implant for ventralight st will be considered as (b)(6) 2012, since the initial legal claim identified the implant date for the marlex mesh (bard flat mesh) as (b)(6)2012.Addendum per additional information provided: (b)(6) 2012 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #1).Per operative notes, ¿all of the layers of the abdominal wall were very attenuated including fascia and it was thought that this weakness was led to hernia.A bard flat mesh (device #1) was then used for reinforcement and strength thereby tacked to the anterior surface of the rectus sheath.¿ (b)(6) 2012 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st using echo ps (device #2).Per operative notes, ¿once the adhesions were detached from the anterior abdominal wall, the hernia defect was inspected.A ventralight st mesh (device #2) was then secured using echo ps to the anterior abdominal wall and tacked.¿ (note: there is no mention/visualization of bard flat mesh (device #1) in operative notes).(b)(6) 2014 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the removal of both bard flat mesh (device #1) and ventralight st mesh (device #2) thereby implanted with ventralex st (device #3).Per operative notes, ¿the previously placed open bard flat mesh (device #1) was found crumpled and was completely excised.The laparoscopically placed mesh was adherent to the underlying omentum, partially occluding the lower half of the giant ventral hernia.This ventralight st mesh (device #2) was also dissected off its attachments to the anterior abdominal wall and subcutaneous tissue.Then the large ventral hernia sac was dissected, and anterior component separation was performed.A ventralex st mesh (device #3) was placed on the anterior abdominal wall and sutured.¿ attorney alleges that the patient had adhesions, pain, hernia recurrence, mesh removal surgery and emotional injuries.

• 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: 10407886
• Report Number: 1213643-2020-07477
• Device Sequence Number: 2552799
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: 11/28/2012
• Device Catalogue Number: 5955810
• Device Lot Number: HUVK1317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2011
• 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: 75 YR
• Patient Sex: Female