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

Catalog Number 5950040

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Liver Laceration(s) (1955)

Event Date 12/20/2022

Event Type  Injury  

Event Description

Per legal claim: attorney alleges that the patient underwent laparoscopic ventral hernia repair and implanted with the bard/davol ventrio st on (b)(6) 2018.It is alleged that during post operative visits from (b)(6) 2018 to (b)(6) 2018, the patient continued to have postoperative pain and discomfort.In february 2020, the patient continued to experience worsening symptoms with progressive epigastric pain, nausea, constipation, food and liquid intolerance, anxiety, and depression.On (b)(6) 2022, esophagogastroduodenoscopy was then performed, which confirmed ¿gastric bypass with a small-sized pouch and intact staple line".On (b)(6) 2022, exploratory laparoscopy was performed which finds for significant abdominal adhesions ¿related to her upper mesh¿ involving the roux limb, which was kinked and balled, requiring surgical lysis.Bariatric surgery has been consulted.It is alleged that during further exploration surgeon realized that the mesh was implanted backwards and found catastrophically formed severely dense adhesions.The pathologic findings shown that the ¿severe adhesions of the roux limb and liver to the mesh causing substantial distortion.It appeared that the mesh was placed inadvertently in the upside-down position.On (b)(6) 2022, patient underwent exploratory mesh removal surgery.Per the operative notes, ¿we started to perform adhesiolysis again.The roux limb was completely removed, the liver was densely adherent to this large piece of mesh; it was approximately 12 x 12 cm.Taking the liver off the mesh did cause some multiple tears in the liver capsule.We could see that the side of the mesh with the blue threads were facing the anterior abdominal wall.It seemed that it was possible that the mesh had been placed inadvertently upside down.I removed the mesh out".It is alleged that the patient experienced pain, injuries, severe psychological distress and physical distress.It was also reported that the event caused by the gross negligence and reckless failure of the implanting surgeon in not following bard¿s written product instruction for use.

Manufacturer Narrative

No conclusions can be made.Attorney alleges that the patient had abdominal pain, adhesions, liver lacerations and underwent mesh removal.It was also reported that the event caused by the gross negligence and reckless failure of the implanting surgeon in not following instruction for use (ifu).The instructions-for-use supplied with the device list adhesions as a possible complication.Review of manufacturing records confirms product was manufactured to specification.The contraindications section of ifu states, "literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera" and the surface orientation section of ifu states "it is extremely important that this product be oriented correctly to function as intended.The visceral side of the ventrio st hernia patch is designed to temporarily separate tissue surfaces and minimize tissue attachment to the mesh.Place the bioresorbable coated side of the prosthesis against those surfaces where minimal tissue attachment is desired, i.E., against bowel or other visceral structures.The uncoated polypropylene mesh side should face the surface where tissue ingrowth is desired.The uncoated polypropylene mesh surface should never be placed against the bowel or other visceral structures".Should additional information be provided, a supplemental emdr will be submitted.Device not returned.

Manufacturer Narrative

No conclusions can be made.Attorney alleges that the patient had abdominal pain, adhesions, liver lacerations and underwent mesh removal.It was also reported that the event caused by the gross negligence and reckless failure of the implanting surgeon in not following instruction for use (ifu).The instructions-for-use supplied with the device list adhesions as a possible complication.Review of manufacturing records confirms product was manufactured to specification.The contraindications section of ifu states, "literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera" and the surface orientation section of ifu states "it is extremely important that this product be oriented correctly to function as intended.The visceral side of the ventrio st hernia patch is designed to temporarily separate tissue surfaces and minimize tissue attachment to the mesh.Place the bioresorbable coated side of the prosthesis against those surfaces where minimal tissue attachment is desired, i.E., against bowel or other visceral structures.The uncoated polypropylene mesh side should face the surface where tissue ingrowth is desired.The uncoated polypropylene mesh surface should never be placed against the bowel or other visceral structures".Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the date mentioned in describe event or problem.Should additional information be provided, a supplemental emdr will be submitted.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 Description

Per legal claim: attorney alleges that the patient underwent laparoscopic ventral hernia repair and implanted with the bard/davol ventrio st on (b)(6) 2018.It is alleged that during post operative visits from (b)(6)( 2018 to (b)(6) 2018, the patient continued to have postoperative pain and discomfort.In (b)(6) 2020, the patient continued to experience worsening symptoms with progressive epigastric pain, nausea, constipation, food and liquid intolerance, anxiety, and depression.On (b)(6) 2020, esophagogastroduodenoscopy was then performed, which confirmed ¿gastric bypass with a small-sized pouch and intact staple line".On (b)(6) 2022, exploratory laparoscopy was performed which finds for significant abdominal adhesions ¿related to her upper mesh¿ involving the roux limb, which was kinked and balled, requiring surgical lysis.Bariatric surgery has been consulted.It is alleged that during further exploration surgeon realized that the mesh was implanted backwards and found catastrophically formed severely dense adhesions.The pathologic findings shown that the ¿severe adhesions of the roux limb and liver to the mesh causing substantial distortion.It appeared that the mesh was placed inadvertently in the upside-down position.On (b)(6) 2022, patient underwent exploratory mesh removal surgery.Per the operative notes, ¿we started to perform adhesiolysis again.The roux limb was completely removed, the liver was densely adherent to this large piece of mesh; it was approximately 12 x 12 cm.Taking the liver off the mesh did cause some multiple tears in the liver capsule.We could see that the side of the mesh with the blue threads were facing the anterior abdominal wall.It seemed that it was possible that the mesh had been placed inadvertently upside down.I removed the mesh out".It is alleged that the patient experienced pain, injuries, severe psychological distress and physical distress.It was also reported that the event caused by the gross negligence and reckless failure of the implanting surgeon in not following bard¿s written product instruction for use.

• Brand Name: VENTRIO ST
• Type of Device: 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: 16619101
• MDR Text Key: 312072293
• Report Number: 1213643-2023-00119
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 5950040
• Device Lot Number: HUBN1764
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 54 KG