MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number 0115320

Device Problem Migration (4003)

Patient Problems Hernia (2240); Obstruction/Occlusion (2422)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

As reported, 2 weeks post-implant the patient experienced adverse symptoms.A ct scan showed small bowel obstruction.One month postoperatively, the patient underwent surgical intervention for mesh removal.During the explant procedure, it was noted that the small bowel obstruction was related to adhesions to the mesh from the small bowel due to the reliatack (non-bard/davol) fixation failure, as several loose tacks were found in the peritoneum.As reported it appears the small bowel obstruction and adhesions to the mesh were a result of the failure of the non-bard/davol fixation used to fixate the mesh.However, a definitive conclusion could not be made.Adhesion and hernia recurrence are known inherent risks of hernia repair surgery and is listed in the adverse reactions section of the instructions for use (ifu) as possible complications.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the reported event.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in june, 2020.This mdr represents the bard/davol 3dmax right repair (device #2).An additional mdr was submitted to represent the bard/davol 3dmax left repair (device #1).Should additional information be provided a supplemental mdr will be submitted.

Event Description

The following was reported via maude event report (mw5100823): "patient had lap tapp right inguinal hernia repair on (b)(6)2021 and returned to operating room on (b)(6)2021 with bowel obstruction, during bowel obstruction surgery, bowel had adhesions to mesh and several loose tacks in the peritoneum.Fda safety report id#(b)(4)." addendum per additional information: ni-ni-2019 - the patient with a history of abdominal surgeries underwent an open right inguinal hernia repair.(b)(6) 2021 - the patient underwent bilateral inguinal hernia repair and was implanted with two bard/davol 3dmax mesh (device #1 and device #2), which were fixated using a non bard/davol (reliatack) fixation device.It is unknown if mesh was placed during the 2019 repair procedure; however, the presence of a mesh was not noted in the operative note.(b)(6) 2021 - postoperatively the patient experienced adverse symptoms and underwent a ct scan.(b)(6) 2021 - the patient underwent subsequent surgical intervention to remove both mesh devices.As reported there was a small bowel obstruction related to adhesions to the mesh from the small bowel due to reliatack fixation failure.The patient was released from the hospital two days post revision procedure.

• Brand Name: 3DMAX
• 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: 11850019
• MDR Text Key: 251454573
• Report Number: 1213643-2021-20121
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/04/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 0115320
• Device Lot Number: HUET0242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR