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

Catalog Number	1190400
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient with a complex medical and surgical history was implanted with a phasix mesh and experienced hernia recurrence and adhesions 2 years post implant.Based on the information provided, there is no way to determined why the posterior rectus sheath pulled away from the phasix mesh, or how this may have contributed to the reported hernia recurrence.Adhesions and hernia recurrence are known inherent risks of hernia repair surgery and are identified as possible complications in the instructions-for-use supplied with the device.To date this is the only reported complaint for this lot.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a robotic rives procedure and was implanted with a phasix mesh (20x25cm).As reported the hernia had reoccurred and the patient underwent a revision surgery on (b)(6) 2020 to fix the hernia.During the procedure, the surgeon found that the posterior rectus sheath pulled away from the phasix mesh, casing adhesions on the bowel and that the phasix mesh then had a central failure, resulting in the recurrence.As reported, a ventrio st mesh was pulled from the hospital shelf and used for reinforcement of the recurrent hernia.The surgeon placed the ventrio st mesh in the patient and then used a non-bard/davol fixation system to place 33 tacks through the outer pocket and into the patient.

• Brand Name: PHASIX 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: 10507753
• Report Number: 1213643-2020-08084
• Device Sequence Number: 3134811
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 09/28/2019
• Device Catalogue Number: 1190400
• Device Lot Number: HUBV1255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/09/2020
• 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
• Patient Age: 70 YR