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

Catalog Number	0010214
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Sepsis (2067); Peritonitis (2252); Bowel Perforation (2668)
Date of Event	05/17/2016
Type of Reportable Event	Death
Event or Problem Description
Per information provided:(b)(6) 2012 - patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with the implant of ventralex st mesh (device #1).Per operative notes, "the hernia sac attached to the small intestine were taken down and reduced into the peritoneum cavity.The defect was measured and a ventralex mesh (device #1) was fixed with both ends away from the hernia sac by suturing to the fascia." (b)(6) 2014 patient was diagnosed with recurrent incisional hernia with small bowel incarceration thereby underwent exploratory laparoscopy with lysis of adhesions.Per operative notes, "identified and removed the hernia sac, the inferior border of the ventralex mesh (device #1) and the lower part of the fascia.There were significant number of adhesions from the fascia which were cleaned and the small bowel was repaired with two layers of sutures.There is probably tissue covering the mesh itself, so choose to not remove it." (b)(6) 2014 to (b)(6) 2016 - patient had multiple hospital visits for abdominal wall wound infection, umbilical abscess and draining serosanguineous fluid thereby provided antibiotics.(b)(6) 2016 - patient was diagnosed with large recurrent incisional hernia thereby underwent repair with excision of previous mesh (device #1) and implant of ventrio mesh (device #2).Per operative notes, "hernia sac was completely excised, and part of the small bowel adhered to the underlying mesh (device #1) was carefully dissected.Then, placed a ventrio mesh (device #2) with the gore-tex side facing the bowel and sutured.Tacker was used to tack the rest of the mesh to the fascia." patient was discharged on (b)(6) 2016 without any complications.(b)(6) 2016 - patient died due to ¿probable sepsis secondary to small bowel perforation with peritonitis and complications of recent ventral hernia repair surgery¿ as per autopsy report.During autopsy, patient was noted to have perforated small bowel beneath recently placed abdominal mesh (device #2), localized peritonitis with exudate, mesenteric inflammation with fat necrosis, status post previous abdominal ventral hernia repair with residual mesh and generalized atherosclerosis.It was mentioned that the mesh (device #2) was placed deep to the previous mesh (device #1) which is embedded in scar tissue in the abdominal wall.Attorney alleges that the patient had death, bowel perforation, infection, adhesions, bowel obstruction, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 5 days post implant of ventrio mesh, patient passed away on (b)(6) 2016.Per autopsy report, it was found that the cause of death is "probable sepsis secondary to small bowel perforation with peritonitis and complications of recent ventral hernia repair surgery." during autopsy, patient was noted to have perforated small bowel beneath recently placed abdominal mesh.Localized peritonitis with exudate, mesenteric inflammation with fat necrosis, status post previous abdominal ventral hernia repair with residual mesh and generalized atherosclerosis.It was mentioned that the mesh was placed deep to the previous mesh which is embedded in scar tissue in the abdominal wall.The instructions-for-use supplied with the device list bowel perforation as a possible complication.This emdr represents the ventrio mesh (device #2).Additional supplemental emdr was submitted to represent the ventralex st (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.

• Brand Name: VENTRIO MESH
• 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: 20543709
• Report Number: 1213643-2024-094774
• Device Sequence Number: 7872672
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417(17)180128(10)HUYL0450
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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: 01/28/2018
• Device Catalogue Number: 0010214
• Device Lot Number: HUYL0450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/28/2024
• 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: Death
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 138 KG