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

Catalog Number 0112780

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Pain (1994); Hernia (2240); Injury (2348); Disability (2371)

Event Date 09/26/2014

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.Hernia 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.This emdr is reflective of the information for device # 1, a separate emdr will be filed for device # 2.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) 2013, the patient underwent surgery for repair of bilateral inguinal hernias.As reported, two bard/davol perfix plugs, reference number (b)(4), lot number huwf2454 (device # 1) and reference number (b)(4), lot number huwi1301 (device # 2) were implanted to repair the hernia defects.It is alleged that on (b)(6) 2015, the patient underwent an additional surgery to repair the hernia defect and add two bard/davol 3dmax implants.It necessitated the "removal of the patient's lower pelvis to fixate." 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 plugs.

Event Description

It is alleged by the patients attorney that on (b)(6) 2013, the patient underwent surgery for repair of bilateral inguinal hernias.As reported, two bard/davol perfix plugs, reference number (b)(4), lot number huwf2454 (device # 1) and reference number (b)(4), lot number huwi1301 (device # 2) were implanted to repair the hernia defects.It is alleged that on (b)(6) 2015, the patient underwent an additional surgery to repair the hernia defect and add two bard/davol 3dmax implants.It necessitated the "removal of the patient's lower pelvis to fixate." 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 plugs.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with the implant of two perfix plugs (device #1 & device #2).Per operative notes, ¿on the right side, a massive direct weakness was noted and reduced.A floor of the inguinal canal was repaired with a extra large perfix plug (device #1), sewn circumferentially with tacking sutures.Onlay mesh was also required to create a tight deep ring.On the left side, smaller hernia defect was noted and large perfix plug (device #2) was secured in place.¿ (b)(6) 2014 - patient was diagnosed with symptomatic recurrent bilateral inguinal hernias thereby underwent open repair with the implant of two perfix plugs (device #3 & device #4).Per operative notes, ¿on the left side, a very large direct weakness was noted recurrent.The mesh was somewhat displaced laterally.This was opened, an extra large perfix plug (device #3) was secured and sewn circumferentially.On the right side, identical findings were noted and extra large perfix plug (device #4) was secured and sewn circumferentially.¿ (b)(6) 2015 - patient was diagnosed with recurrent direct bilateral inguinal hernias thereby underwent laparoscopic repair with the implant of two 3dmax meshes (device #5, #6) and one bard flat mesh (device #7).Per operative notes, ¿on inspection of the abdomen, there were 2 large defects on both sides.Patient did have 2 large perfix plugs (device #1, #2, #3, #4) in each space, which were very well incorporated and left in place.The whole lower pelvis was dissected out allowing placement of mesh.Two large 3dmax meshes were placed on the left (device #5) and right space (device #6) covering the direct, indirect, and femoral spaces and secured with tacker.However, a polypropylene sheath was cut to fit to cover all thick hernia spaces in the superior margin and covered the bard flat mesh (device #7) as well.It was secured in place using tacker.¿ attorney alleges that the patient had mesh migration, pain and hernia recurrence.

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.Hernia 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.This emdr is reflective of the information for device # 1, a separate emdr will be filed for device # 2.If additional information is obtained, a supplemental mdr will be submitted.Addendum: h11: this supplemental emdr is submitted to document additional information provided, to correct date of event and manufacturing 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 few years post implant of perfix plug, patient was diagnosed with mesh migration, hernia recurrence thereby underwent additional surgery.Per op notes, "the mesh was somewhat displaced laterally." a review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: a2, b4, b5, b7, e3, f12, g1, g3, g6, h2, h6, h10, h11.Corrected fields: b3 (date of event), h4 (manufacturing date).This supplemental emdr represents the perfix plug (device #1).Additional supplemental emdr was submitted to represent the perfix plug (device #2) and emdrs were submitted to represent two perfix plugs (device #3 and device #4).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: 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: 7143922
• MDR Text Key: 95718071
• Report Number: 1213643-2017-01106
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622
• 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
• Report Date: 12/28/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Catalogue Number: 0112780
• Device Lot Number: HUWF2454
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2012
• 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: 37 YR
• Patient Sex: Male