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

Catalog Number	1220011
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported early postoperative adhesions occurred.The sample was not provided for evaluation.Photos were provided showing both sides of the mesh post explant, and also a photo of the distended bowel and dilated bowel.Review of the photos did not assist in determining a root cause for the postoperative adhesions and obstruction.As reported the mesh was not hydrated prior to implant as prescribed in the instructions-for-use, it is unclear if this may have contributed to the postoperative adhesions and obstruction.Based on the information provided and photo evaluation, no conclusion can be made.The instructions-for-use states, "hydration of the device for 1-3 seconds is recommended." and "deviation from recommended instructions and/or procedural steps within this ifu may result in disruption or delamination of the hydrogel barrier of the mesh.Hydrogel disruption or delamination may cause an unexpected increase in adhesion formation in the area where it is disrupted." adhesion formation is a known inherent risk of surgery and is listed in the adverse reaction section of the ifu as a possible complication.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in july, 2019.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Not returned.
Event or Problem Description
It was reported that on (b)(6) 2020 the patient was implanted intra-abdominally with a bard phasix st mesh (ops) during an open umbilical hernia repair procedure.As reported the mesh was not hydrated prior to implant.The sepra (st) barrier was properly oriented toward the bowel with the mesh side toward the abdominal wall.On (b)(6) 2020 due to an obstruction the patient was bought back to the or and underwent explant of the mesh.Dense adhesions to the mesh were reported.The doctor noted that in a photo taken of the bowel you can "clearly see where the distended bowel and dilated bowel are that caused the obstruction and in the center you can see the left behind seprafilm from the mesh.".

• Brand Name: PHASIX ST W/ OPS
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9864835
• Report Number: 1213643-2020-02800
• Device Sequence Number: 19629092
• Product Code: OWT
• UDI-Device Identifier: 00801741163173
• UDI-Public: (01)00801741163173
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K190185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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: 04/28/2020
• Device Catalogue Number: 1220011
• Device Lot Number: HUDR0705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/23/2020
• 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