MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventrio ST; Surgical Mesh

Catalog Number	5950080
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Scar Tissue (2060); Injury (2348)
Date of Event	06/10/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventrio st (device #2) used to treat the patient.The patient's attorney did allege surgical intervention; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol ventrio st (device #2).An additional emdr was submitted to represent the bard/davol composix mesh (device #1) and the bard/davol flat mesh (device #3).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix (device #1) or an unspecified bard/davol ventrio st (device #2) and an unspecified bard/davol unknown bard hernia mesh (device #3) sometime in 2012.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol composix (device #1), the ventrio st (device #2) and an unknown bard hernia mesh (device #3).As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix (device #1) or an unspecified bard/davol ventrio st (device #2) and an unspecified bard/davol unknown bard hernia mesh (device #3) sometime in 2012.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol composix (device #1), the ventrio st (device #2) and an unknown bard hernia mesh (device #3).As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2012 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventrio st (device 2).Per op notes, ¿midline incision was made.The hernia was identified and freed up the bowel adhesions and reduced the bowel into the abdominal cavity.The sac was excised.A ventrio st (device 2) was placed and sutured.¿ (b)(6) 2014 - patient was diagnosed with infected mesh, adhesions and abscess thereby underwent open repair with excision of ventrio st (device 2) and implant of xenmatrix graft (device 4).Per op notes, ¿midline scar was excised.The infected mesh was incised, and small bowel was noted to be stuck to it.The small bowel plastered to the mesh was taken down.Lysis of adhesions was performed to free the mesh (device 2) from the small bowel.Once the mesh was freed and the entire mesh (device 2) was excised and removed.Component separation was performed.A xenmatrix graft (device 4) was placed as an underlay and secured using sutures.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventrio st (device #2) used to treat the patient.The patient's attorney did allege surgical intervention; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-apr-2012) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b6, b7, d3, d4 (product catalog no., corporate lot no., udi no., expiry date), d6a, d6b, g1, g3, g6, h2, h4, h6, h10.This supplemental emdr represents the bard/davol ventrio st (device 2).Additional supplemental emdrs were submitted to represent the bard/davol composix mesh (device 1) and the bard/davol bard flat mesh (device 3).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. -1213643; 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 ; +1(401)825-8495
• MDR Report Key: 9131537
• Report Number: 1213643-2019-09481
• Device Sequence Number: 2528586
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571(17)140428(10)HUWD1344
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• 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): 08/27/2026

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: 04/28/2014
• Device Catalogue Number: 5950080
• Device Lot Number: HUWD1344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2012
• 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 Sex: Female