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

Catalog Number	1201020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported postoperative complications and any problem with the phasix st hernia mesh used to treat the patient.As reported there has been no intervention (i.E.Imaging, surgical intervention) as it is reported that the patient refused further treatment.At this time, no definitive conclusion can be made.Recurrence is a known inherent risk of hernia repair surgery.Regarding recurrence the warning section of the instructions-for-use states, "to prevent recurrences when repairing hernias, phasix st mesh must be large enough to provide sufficient overlap beyond the margins of the repair/primary closure.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional information is provided, a supplemental emdr will be submitted.Note: 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.Remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced a hernia recurrence.(b)(6) 2016 - the patient underwent a robotic assisted repair of an epigastric and umbilical hernia using the davol phasix st hernia mesh.The hernia is documented to be of swiss cheese configuration (multiple discreet hernias).The mesh was placed to extend at least 5cm beyond the margins of the defect.The operative details note the patient had a weight loss of 30 lbs in the 10 months prior to this procedure which created laxity of the abdominal wall and ability to perform the procedure without using component separation technique.(b)(6) 2016 - the patient presented with abdominal tenderness.This was assessed as mild and possibly related to the device and possibly related to the procedure.A resolution date of 06/09/2017 has been documented.(b)(6) 2018 - the patient was diagnosed with a recurrent hernia upon physical exam.The patient did not undergo additional imaging or surgical intervention as it is reported the subject refused further treatment.It is reported the subject patient gained 31 lbs in the last 7 months.The hernia recurrence has been assessed as possibly related to the device and possibly related to the procedure.

• 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: 7378873
• Report Number: 1213643-2018-00817
• Device Sequence Number: 13823657
• Product Code: OWT
• UDI-Device Identifier: 00801741095313
• UDI-Public: (01)00801741095313
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: health professional,other,stu
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: 02/28/2017
• Device Catalogue Number: 1201020
• Device Lot Number: HUAP0395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2018
• Initial Report FDA Received Date: 03/28/2018
• 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: 50 YR
• Patient Weight: 124