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

Catalog Number	5950040
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per the medical records review, about 5 months post implant of ventrio st, patient had hernia recurrence.The instructions-for-use supplied with the device identify hernia recurrence as a possible complication.This emdr represents the ventrio st (device #2).An additional supplemental emdr was submitted to represent the sepramesh ip (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 by patient's attorney: on (b)(6) 2012 - patient was diagnosed with large incisional hernia thereby underwent open repair with implant of sepramesh ip (device #1).Per operative notes, "there were a few adhesions between the bowel and the hernia sac which were reduced.A sepramesh ip (device #1) was cut for the defect, placed below the level of the fascia and sutured.¿ on (b)(6) 2014 - patient visited hospital for abdominal wall hernia.On (b)(6) 2014 - patient was diagnosed with pain, recurrent incisional hernia thereby underwent open repair with the explant of mesh (device #1).Per operative notes, "hernia sac was protruding, appeared to be laterally from mesh that had pulled away.Lysis of adhesions to free up the segment of the small bowel was performed.Once it was freed up, undersurface of the old mesh (device #1) was removed or portion thereof it removed.Some other crease of mesh that was left behind.A piece of ventrio st hernia patch (device #2) was placed into the defect.¿ on (b)(6) 2015 - patient had small recurrence of hernia, reduces easily and pops back out a little bit.Patient will be reconsidered for another repair if hernia starts to be bigger or cause symptoms.Attorney alleges that the patient had adhesions, fistulae, mesh migration, pain, hernia recurrence and mesh pulled away from hernia defect.

• 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: 17836016
• Report Number: 1213643-2023-093868
• Device Sequence Number: 7695741
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2023

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: 04/28/2015
• Device Catalogue Number: 5950040
• Device Lot Number: HUXD1993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/28/2023
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 92 KG