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

Model Number 0115311

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

Patient Problems Adhesion(s) (1695); Nerve Damage (1979); Pain (1994); Disability (2371); Neuralgia (4413)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided indicated that the patient underwent an additional surgery to "repair the hernia defect and remove it.As medical records were not provided and the description does not clearly define was "remove it" is being referred to we have not identified this to be a reported device explant at this time.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard 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 bard.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2015 - the patient underwent surgery for repair of a left inguinal hernia with implant of a 3dmax mesh.On (b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect and remove it.During the surgery, the patient noted that "the mesh was clamshelled along the lower third and it was also folded medially." the patient was injured severely and permanently.The attorney alleges the patient has suffered and will continue to suffer physical pain.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2015 - the patient underwent surgery for repair of a left inguinal hernia with implant of a 3dmax mesh.(b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect and remove it.During the surgery, the patient noted that "the mesh was clamshelled along the lower third and it was also folded medially." the patient was injured severely and permanently.The attorney alleges the patient has suffered and will continue to suffer physical pain.Addendum per additional information provided: (b)(6) 2015 - patient with history of abdominal pain was diagnosed with left inguinal hernia and was scheduled for robotic-assisted laparoscopic repair with 3dmax, left mesh.Per the operative report details, "the left inguinal spermatic cord was freed from the hernia sac.I then placed a large 3dmax mesh (left) into the left inguinal region covering the indirect and direct spaces.¿ a single 2-0 vicryl suture was placed in interrupted fashion, through the mesh to cooper¿s ligament.(b)(6) 2015 to (b)(6) 2015 - patient had frequent hospital visits due to left lower abdominal, groin and testicular pain.(b)(6) 2015 - patient was diagnosed with ilioinguinal neuralgia and abdominal pain and underwent ilioinguinal nerve block procedure.(b)(6) 2015 - patient was diagnosed with chronic lower left quadrant abdominal pain, inguinodynia and was scheduled for diagnostic laparoscopy, left cord lipoma with mesh excision on (b)(6) 2015.Per the op-notes, there were no masses or hernias; the first mesh segment adherent to the inferior epigastric vessels and was carefully peeled off."at this time, we noted there was herniating extraperitoneal fat lateral to the cord.This was clearly a routine lipoma.We then excised the next portion of mesh.We then took all the mesh out, except for small amounts densely adherent to the left external iliac vein and a tiny amount to the bladder.Other than these 2 areas, the entire piece of mesh was removed.Any soft tissue that was adherent to the mesh was resected.The mesh was clam-shelled along the lower third.It was also folded medially.¿ the surgeon also noted that despite findings of an obvious lipoma and the clamshell of the 3dmax mesh, these would not directly explain the patient¿s local pain which predated the previous hernia repair.(b)(6) 2016 & (b)(6) 2016 - patient underwent additional nerve bock procedures due to chronic groin pain.Attorney alleges, mesh shrinkage, pain, hernia recurrence and emotional injuries.

Manufacturer Narrative

Currently, it is unknown whether to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided indicated that the patient underwent an additional surgery to "repair the hernia defect and remove it.As medical records were not provided and the description does not clearly define was "remove it" is being referred to we have not identified this to be a reported device explant at this time.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: h11: this supplemental mdr is submitted to document additional information provided and to correct the implant date.Based on the additional information received, no conclusions can be made.Medical records show prior to the 3dmax mesh implant the patient had a history of abdominal pain, which continued following implant.The surgeon also noted that despite findings of an obvious lipoma and the clamshell of the 3dmax mesh, these would not directly explain the patient¿s local pain which predated the previous hernia repair.The instructions-for-use supplied with the device lists adhesions as a possible complication.Note: based on the additional information received we confirmed this event was previously reported to the fda reference 1213643-2014-00404.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: 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: 6873435
• MDR Text Key: 86558331
• Report Number: 1213643-2017-00603
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 0115311
• Device Catalogue Number: 0115311
• Device Lot Number: HUZB0180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• 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: 18 YR
• Patient Sex: Male
• Patient Weight: 67 KG