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

Catalog Number	5955113
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	09/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported the surgeon encountered some difficulty during fixation of the mesh during the implant procedure.Some of the bard/davol sorbafix fasteners pulled out and the mesh was reinforced with additional fixation using a non bard fixation device.Eight days post implant the patient presented with a hernia recurrence.Based on the information provided to date a root cause for the hernia recurrence cannot be determined.The mesh and fixation device were discarded and therefore unavailable for evaluation.Regarding fixation the instructions for use states, "care should be taken to ensure that the mesh is adequately fixated to the abdominal wall.If necessary, additional fasteners and/or sutures should be placed." additionally, recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section as a possible complication.This mdr represents the bard ventralight st w/ echo ps, an additional mdr was submitted to represent the bard sorbafix fixation device.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 or Problem Description
It was reported that the patient underwent a procedure in which a bard ventralight st w/ echo ps was used.As reported the surgeon fixated the mesh using bard sorbafix tackers and then removed the balloon (echo ps).It is reported that once the balloon (echo ps) was removed it was noted that some of the tackers were detached.The mesh was reinforced using a non bard fixation device.As reported eight days post implant the hernia recurred with strangulation of entrails as the tackers did not fix the mesh, the mesh was folded and introduced into the hernia defect causing the patient pain.The patient underwent an additional procedure to remove the mesh, it was noted that the bard sorbafix tackers did not fix the mesh correctly.
Additional Manufacturer Narrative
This is a correction to the previously submitted mdr.Additional information was received indicating a correction to the explant date that was initially reported and to correct the error initially reported in the patient id.

• Brand Name: VENTRALIGHT ST W/ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6918970
• Report Number: 1213643-2017-00656
• Device Sequence Number: 10975890
• Product Code: FTL
• UDI-Device Identifier: 00801741031694
• UDI-Public: (01)00801741031694(17)181028(10)HUAX1038
• Combination Product (Y/N): N
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 10/28/2018
• Device Catalogue Number: 5955113
• Device Lot Number: HUAX1038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 86