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

Catalog Number	5950060
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	06/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and the bard/davol device used to treat the patient.The patient's attorney did not allege any specific device failure and medical records have not been provided.A sample was not returned for further evaluation.No lot number was provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided by the patient's attorney, no conclusions can be made between the bard/davol device used to treat the patient and any problem with the device.Should additional information be provided, a supplemental emdr will be submitted.This emdr represents the bard/davol ventrio st (device 1).The patient's attorney made no allegation related to the bard/davol phasix mesh.Note: 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.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2015 - the patient underwent surgery for implant of an unspecified bard/davol ventrio st (device 1).On (b)(6) 2015 - the patient underwent surgery for implant of an unspecified bard/davol phasix mesh.As alleged, the patient is making a claim for an adverse patient outcome against the ventrio st (device 1) only.As reported, the patient's attorney alleges a general claim related to the ventrio st (device 1) "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained.".
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2015 - the patient underwent surgery for implant of an unspecified bard/davol ventrio st (device 1).(b)(6) 2015 - the patient underwent surgery for implant of an unspecified bard/davol phasix mesh.As alleged, the patient is making a claim for an adverse patient outcome against the ventrio st (device 1) only.As reported, the patient's attorney alleges a general claim related to the ventrio st (device 1) "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained." addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of ventrio st mesh (device #1).Per operative notes, ¿the hernia sac was excised.The ventrio st mesh (device #1) was placed into the abdomen and sutured.¿ (b)(6) 2015 - patient was diagnosed with recurrent ventral hernia and exploratory laparotomy thereby underwent open repair with the explant of old mesh (device #1) and implant of phasix mesh (device #2).Per operative notes, ¿the fascia was identified under the seroma, the ventrio st mesh (device #1) was able to pull away entirely from the abdominal wall.The seroma was entirely drained, and the adhesions of omentum was taken down.The phasix mesh (device #2) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with excision and debridement of nonviable and chronically inflamed tissue.(b)(6) 2017 - patient was diagnosed with abdominal wall wound and infection.Attorney alleges that the patient had adhesions, pain, infection, hernia recurrence and seroma.It was also alleged that the patient had excision and debridement of nonviable and chronically inflamed tissue and washout of abdominal wound.
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and the bard/davol device used to treat the patient.The patient's attorney did not allege any specific device failure and medical records have not been provided.A sample was not returned for further evaluation.No lot number was provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided by the patient's attorney, no conclusions can be made between the bard/davol device used to treat the patient and any problem with the device.Addendum: this supplemental emdr is submitted to document additional information provided: based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 4 weeks post implant of ventrio st, patient was diagnosed with hernia recurrence, seroma, mesh migration & adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list hernia recurrence, seroma, mesh migration & adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-mar-2015) is considered to be a best estimate.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: VENTRIO ST
• 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: 7683278
• Report Number: 1213643-2018-02384
• Device Sequence Number: 16472917
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557(17)170328(10)HUZC0148
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 5950060
• Device Lot Number: HUZC0148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2015
• 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: 35 YR
• Patient Sex: Female