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

Catalog Number	1201520
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on medical records provided two years post implant the patient presented to the er after working on his car and lifting a tire.He had complaints of abdominal pain, nausea and increased blood pressure.The patient was evaluated and an abdominal bulge was noted.The patient was referred to follow up with general surgeon and three months later was diagnosed with a recurrent incisional hernia.As reported the patient smokes cigarettes and was informed that one factor of hernia recurrence is smoking.He was informed that given his multiple recurrences and smoking status he had a very risk of recurrence.The patient is not interested in quitting.At this time, based on medical records provided there has been no surgical intervention as the surgeon was hesitant to offer surgery that is not emergent in a patient who is relatively non-compliant.Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication.At this time no conclusions can be made to what extent the bard/davol phasix st mesh may have caused or contributed to the patient hernia recurrence.Should additional information be provided a supplemental emdr will be submitted.This file represents the device 2.An additional emdr was submitted to represent the other bard device reference 1213643-2018-03698 (device 1).Remains implanted.
Event or Problem Description
The following is based on medical records provided by the patient's attorney: (b)(6) 2004, the patient was diagnosed with a ventral umbilical hernia and underwent repair with implant of a bard/davol composix kugel mesh (device 1).(b)(6) 2016, the patient had an office visit with complaints of a bulge developing in the midline of the abd.A bulge had been there for years and getting bigger with time with some pain.Patient was diagnosed with an incisional hernia.(b)(6) 2016, the patient was diagnosed with recurrent incisional hernia and underwent a diagnostic laparoscopy converted to exploratory laparoscopy with small bowel resection, right and left myofascial advancement flaps, repair recurrent incisional hernia with implant of a bard/davol phasix mesh (device 2) and removal of the old composix kugel mesh (device 1).Per the operative report details, "there was a great deal of scar tissue particularly right in the midline at the old mesh (device 1), small bowel was adherent to the mesh (device 1).It appeared that the mesh had actually folded on itself and the small bowel was actually grown into mesh.However, where the small bowel was attached to the mesh had completely grown into the bowel; there was no way i was able to remove this section.Did small bowel resection, removed approximately a foot and a half of small bowel.Once done, laid 15 x 20 cm phasix st mesh (device 2) within this submuscular space.The mesh (device #2) was able to be sutured to posterior fascia using a simple interrupted pds suture.(b)(6) 2018, the patient presented to the hospital er with complaints of abd pain, nausea and increased blood pressure after working on his car and lifting a tire.Patient was evaluated and an abd bulge was noted.Patient was referred to follow up with general surgeon.(b)(6) 2019, the patient had an office visit with a surgeon due to an abd bulge with associated abd pain.Patient was diagnosed with a recurrent incisional hernia.Per the surgeon's plan: "discussed some of the factors for hernia recurrence.One of the patient controllable factors is smoking.When asked about quitting he was pretty clear that he was not going to quit cigarettes.Told that given his multiple recurrence and smoking status he had a very risk of hernia coming back and that did not seem to bother him.I am hesitant to offer him a surgery that is not emergent in a patient who is relatively non-compliant.Will review previous records and imaging so that he and i can have a clear discussion about his options.".

• Brand Name: PHASIX ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8859066
• Report Number: 1213643-2019-06652
• Device Sequence Number: 10891246
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 09/28/2018
• Device Catalogue Number: 1201520
• Device Lot Number: HUAV3247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/05/2019
• 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: 66 YR
• Patient Weight: 79