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

Catalog Number	5950040
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Liver Laceration(s) (1955)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• 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: 16619101
• Report Number: 1213643-2023-00119
• Device Sequence Number: 7325209
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 02/28/2019
• Device Catalogue Number: 5950040
• Device Lot Number: HUBN1764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2017
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 54 KG