MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Model Number 0115320

Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Inflammation (1932); Scar Tissue (2060); Hernia (2240); Disability (2371); Fibrosis (3167); Neuralgia (4413)

Event Date 11/13/2013

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.Based on the information provided, it is alleged the patient experienced hernia recurrence, pain and adhesions.Recurrence and adhesions are known inherent risks of hernia surgery and are identified in the adverse reaction section of the instructions-for-use as possible complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.This file represents the 3dmax mesh device (device #1) implanted on the patient's right side, a second emdr was submitted to address the 3dmax mesh device (device #2) implanted on the patients left side.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2012 - the patient underwent surgery for repair of bilateral inguinal hernias, two bard 3dmax mesh devices (device #1 & device #2) were implanted to repair the hernia defects.(b)(6) 2013 - the patient underwent an additional surgery to repair a hernia defect on the right side and remove some old folded mesh.(b)(6) 2014 - the patient underwent an additional surgery to repair a hernia defect on the left side and remove a piece of the old mesh.(b)(6) 2015 - the patient underwent an additional surgery to once again repair the hernia defect on the right side, however, the procedure was aborted due to dense adhesions and the inability to separate he mesh from the perineum.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2012 - the patient underwent surgery for repair of bilateral inguinal hernias, two bard 3dmax mesh devices (device #1 & device #2) were implanted to repair the hernia defects.(b)(6) 2013 - the patient underwent an additional surgery to repair a hernia defect on the right side and remove some old folded mesh.(b)(6) 2014 - the patient underwent an additional surgery to repair a hernia defect on the left side and remove a piece of the old mesh.(b)(6) 2015 - the patient underwent an additional surgery to once again repair the hernia defect on the right side, however, the procedure was aborted due to dense adhesions and the inability to separate he mesh from the perineum.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2012 - patient was diagnosed with bilateral inguinal hernias thereby underwent laparoscopic repair with implant of two 3dmax meshes (device #1 and device #2).Per operative notes, ¿in left groin, moderate sized indirect sac was identified and dissected free.The left preformed medium 3dmax mesh (device #1) was inserted, tacked to pubic tubercle up along the anterior border with tacker.In right groin, there was another indirect sac which carefully dissected.The right preformed 3dmax mesh (device #2) was tacked in place.¿ (b)(6) 2013 - patient visited hospital due to neuralgia and groin pain.(b)(6) 2013 - patient was diagnosed with chronic right groin pain thereby underwent open repair with removal of a piece of mesh (device #2).Per operative notes, ¿external oblique fascia was opened, and the palpable masses followed.Noticed that the tacker was attached to multiple tackers and to a piece of folded mesh or even a plug (device #2).Three tacks and a piece of mesh were removed.¿ (b)(6) 2014 - patient was diagnosed with left groin pain thereby underwent open exploration with removal of tack and a piece of mesh (device #1).Per operative notes, ¿opened the external oblique fascia and found palpable mass protruding through the internal ring.Shaved off the sharp edge of the mesh that was sticking out the internal ring and there was fibrosis.¿ (b)(6) 2015 - patient was diagnosed with fat-containing right inguinal hernia, thereby underwent laparoscopic repair.Per operative notes, ¿mesh (device #2) was very adherent to all structures.The peritoneum could not be separated from the mesh.It did not appear to have true indirect hernia.The fat containing hernia which probably a lipoma of the cord.Concerned about injury and amount of scarring present, the procedure stopped and placed a piece of covering in the raw surface.¿ (b)(6) 2016 - patient visited hospital for right groin pain and hernia.(b)(6) 2018 - patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent open repair with perfix plugs (device #3 & #4).Per operative notes, ¿a direct right hernia was visualized which appeared to be a medial recurrence.Old mesh (device #2) in the preperitoneal space was palpated.A bard perfix plug (device #3) was sutured in place.Then a direct left medial recurrence hernia was identified.The bard perfix plug (device #4) was inserted into the internal ring and sutured in place.¿ attorney alleges that the patient had adhesions, mesh migration, nerve damage, pain.It was also alleged that the mesh was so adherent to structures, the surgeon was unable to remove the mesh and the procedure was aborted due to fear of further complications.As a result, there is a continuation of chronic pain that cannot be resolved surgically.Severe scarring.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.Based on the information provided, it is alleged the patient experienced hernia recurrence, pain and adhesions.Recurrence and adhesions are known inherent risks of hernia surgery and are identified in the adverse reaction section of the instructions-for-use as possible complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.This file represents the 3dmax mesh device (device #1) implanted on the patient's right side, a second emdr was submitted to address the 3dmax mesh device (device #2) implanted on the patients left side.Addendum: this supplemental emdr is submitted to document additional information provided: based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, post implant of right 3dmax mesh, patient was diagnosed with abdominal pain, adhesions, mesh deformation, neuralgia, hernia recurrence, fibrosis, inflammation, scarring thereby underwent repairs with partial removal of mesh.Per op notes ¿noticed a piece of folded mesh or even a plug.¿ the instructions-for-use supplied with the device lists adhesions, inflammation and pain as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This supplemental emdr represents the 3dmax mesh implanted on patient's right side.Additional supplemental emdr was submitted to represent the 3dmax mesh implanted on patient's left side.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.

• Brand Name: 3DMAX
• Type of Device: 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: 7130894
• MDR Text Key: 95325861
• Report Number: 1213643-2017-01071
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 0115320
• Device Catalogue Number: 0115320
• Device Lot Number: HUWB1374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2012
• 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): Disability; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 91 KG