MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO MESH; SURGICAL MESH

Catalog Number	0010212
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930)
Date of Event	10/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about 1.2 years post-implant of the ventrio hernia patch, the patient was diagnosed with enterocutaneous fistula, and surgical site/mesh infection and underwent surgery for mesh removal.The clinician has assessed the patient¿s postoperative course as being "definitely" related to the study device and possibly related to the index procedure.However, based on the information provided, no conclusion can be made.Fistula formation and infection are known inherent risks of surgery.The adverse reactions section of the instructions-for-use (ifu), supplied with the device lists fistula as a possible complication.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." review of the manufacturing records shows the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) released for distribution in (b)(6) 2015.
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2015 - subject patient underwent an open first-time recurrent ventral hernia repair procedure in the left lower quadrant.A bard/davol ventrio hernia patch was placed in underlay fashion intra-peritoneally and was fixated using non-bard/davol mechanical fixation device and sutures.Fascia and skin closure was achieved using sutures and staples.The patient was discharged on (b)(6) 2015.(b)(6) 2016 - subject patient was diagnosed with small enterocutaneous fistula, infected abdominal wall/mesh infection.(b)(6) 2016 - subject patient was admitted to the hospital.(b)(6) 2016 - the entire mesh was mobilized and explanted, large penrose drain placed and the patient was discharged on 22-nov-2016.It was noted that the "fistula may never heal" during the last office visit.Per the study clinician, the reported adverse event has been assessed as severe in severity, definitely related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved with sequelae.

• Brand Name: VENTRIO MESH
• 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 ; 8005566756
• MDR Report Key: 14495322
• Report Number: 1213643-2022-00333
• Device Sequence Number: 20275927
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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: 03/28/2018
• Device Catalogue Number: 0010212
• Device Lot Number: HUZB1731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2015
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 111 KG