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

Catalog Number	1201020
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	05/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, the cause of the patient's hernia recurrence / obstruction cannot be determined.Recurrence is a known inherent risk of hernia repair surgery.Regarding hernia 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.The mesh remains implanted.Surgical intervention is indicated, however has not been scheduled.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.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/bowel obstruction: on (b)(6) 2017 the subject patient underwent robotic-assisted repair of a (first-time), infraumbilical hernia using the phasix st mesh.An intra-abdominal approach was used with no component separation.The total hernia size is measured as 21.2cm (9cml/3cmw).The phasix st mesh was not trimmed and was positioned so that its edges extended beyond the margins of the defect by at least 5cm.Absorbable monofilament suture was used as the method of perimeter fixation with 3 fixation points.Absorbable sutures were placed approx.2cm apart and the fascia was completely re-approximated using a running stitch.Skin closure was attempted with both sutures and surgical glue.On (b)(6) 2019 the subject patient was diagnosed with a small bowel obstruction.On (b)(6) 2019 the subject patient underwent a ct scan which showed evidence of a hernia recurrence.On (b)(6) 2019 to (b)(6) 2019 the subject patient was hospitalized and placed on bowel rest.As reported the patient developed a hernia recurrence which led to a small bowel obstruction.Per clinician, the reported event has been assessed as "definitely related" to the study device and "not related" to the index procedure.

• Brand Name: PHASIX ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8960477
• Report Number: 1213643-2019-08269
• Device Sequence Number: 19473536
• Product Code: OWT
• UDI-Device Identifier: 00801741095313
• UDI-Public: (01)00801741095313
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 1201020
• Device Lot Number: HUAV2562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/04/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR