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

Catalog Number	5954450
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	12/10/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2014 - patient was diagnosed with symptomatic umbilical hernia and possible inguinal hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device #1), perfix plug (device #2) and ventralex st (device #3).Per operative notes, "umbilical hernia sac was reduced.A ventralight st mesh (device #1) was placed in the abdominal wall into the peritoneal cavity and tacked.The direct inguinal defect on the left was identified and a perfix plug (device #2) was placed into the defect.Some of the peritoneum was placed over the mesh.Another ventralex st (device #3) small circle patch was secured over the defect and tacked the mesh to the abdominal wall and inguinal wall." 10-dec-2014 - patient with abdominal pain, mild herniation in umbilical area and recurrent left inguinal hernia had laparoscopic-open repair with the implant of ventralight st w/ echo ps (device #4) and perfix plug (device #5) along with the removal of dislodged perfix plug (device #2).Per operative notes, "adhesions involving a portion of mesh were taken down and no recurrent defect was found.There was some protrusion essentially within the mesh (device #1).Rather than take the mesh out, elected to place a ventralight st w/ echo ps (device #4) above the umbilicus and secured to the anterior abdominal wall.Incision was made to the left groin and previously placed mesh (device #2) was then excised from the spermatic cord.A large perfix plug (device #5) was placed through the defect and secured to the rim of the defect, mesh patch was then sutured to the floor of the canal.¿ attorney alleges that the patient had mesh migration, mesh shrinkage, hernia recurrence, adhesions, pain and emotional injuries.It is also alleged that the cremasteric fibers were amputated and a lipomatous mass of the cord was dissected down to the level of the internal ring.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.About 8 months post implant of ventralight st, obese patient was diagnosed with abdominal pain, hernia recurrence, adhesions thereby underwent revision surgery.Per op notes, "there was some protrusion essentially within the mesh." the instructions-for-use (ifu) supplied with the device identifies hernia recurrence, pain and adhesions as possible complications.This emdr represents ventralight st (device #1).An additional supplemental emdr is submitted to represent perfix plug (device #2) and an emdr to represent ventralex st (device #3).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 : device not returned.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: 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: 18485943
• Report Number: 1213643-2024-090038
• Device Sequence Number: 9077877
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2016
• Device Catalogue Number: 5954450
• Device Lot Number: HUYA0831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 110 KG