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

Model Number 0112980

Device Problems Defective Device (2588); Material Deformation (2976); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Disability (2371)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental 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.

Event Description

It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of a right inguinal hernia.As reported, a bard/davol perfix plug, reference number 0012980, lot number huti1298 was implanted to repair the hernia defect.It is alleged that several years later on (b)(6) 2017, the patient underwent an additional surgery to repair recurrent hernia after the perfix plug allegedly failed and to remove the perfix plug.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective perfix plug.

Manufacturer Narrative

Addendum to the previous report.This supplemental emdr is being sent to correct the manufacture date for the perfix plug.A manufacturing review was performed which found that the device provided was manufactured to specification.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

Event Description

It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of a right inguinal hernia.As reported, a bard/davol perfix plug, reference number 0012980, lot number huti1298 was implanted to repair the hernia defect.It is alleged that several years later on (b)(6) 2017, the patient underwent an additional surgery to repair recurrent hernia after the perfix plug allegedly failed and to remove the perfix plug.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective perfix plug.Addendum per additional information provided: on (b)(6) 2010 - patient was diagnosed with indirect right inguinal hernia thereby underwent open repair with perfix plug (device #1).Per operative notes, "a direct hernia was separated from the cord and reduced.Extra-large perfix plug (device #1) was placed and sutured to the conjoined tendon.A patch was then placed and sutured." on (b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic into open repair with partial explant of perfix plug (device #1) and implanted with bard mesh pre-shaped w/ keyhole (device #2).Per operative notes, "identified a mesh plug (device #1) in the direct space.This was firmly adherent to some adjacent fatty tissue and this was dissected.There was a tremendous amount of scarring between the fascia and the underlying mesh.There was a small direct hernia with fat protruding in the direct space medial to the mesh and this was reduced.There was a large contracted piece of mesh (device #1) in the floor of the canal, removing this would be a very bloody and potentially injurious endeavor elected to leave the mesh.Then repaired the floor with a polypropylene pre-fenestrated mesh (bard pre-shaped w/ keyhole) (device #2)." attorney alleges that the patient had adhesions, mesh migration, hernia recurrence, pain, and emotional injuries.

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental mdr will be submitted.Addendum #1: this supplemental emdr is being sent to correct the manufacture date for the perfix plug.A manufacturing review was performed which found that the device provided was manufactured to specification.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.Addendum #2: h11: this supplemental emdr is submitted to document additional information provided and to correct the type of device and expiry date.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 6 years post implant of perfix plug, patient was diagnosed with mesh deformation, adhesions, hernia recurrence and scar tissue thereby underwent repair with partial removal of mesh.Per op notes," there was a large contracted piece of mesh in the floor of the canal." the instruction for use (ifu) supplied with the device list adhesions as a possible complication.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: PERFIX PLUG
• 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: 7135205
• MDR Text Key: 95397781
• Report Number: 1213643-2017-01081
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• 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,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 0112980
• Device Catalogue Number: 0112980
• Device Lot Number: HUTI1298
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2009
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG