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

Catalog Number	1220011
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the phasix st mesh was implanted near an anastomotic leak and approximately 10 months post-implant, the patient developed bowel obstruction, adhesion and underwent partial bowel resection and mesh removal.It is unclear if the initial placement of the device, may have been a contributing factor to the patient outcome.However, based on the information provided no conclusions can be made.To date this is the only reported complaint received for this lot.Adhesions and pain are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as possible complications.Should additional information be provided, a supplemental emdr will be submitted.Not returned - remains implanted.
Event or Problem Description
It was reported that the patient underwent a primary repair of hartmann's reversal procedure for 4 x 2cm sized hernia defect, in which phasix st w/ open positioning system was used to reinforce the stoma site, near an anastomotic leak on (b)(6) 2019.The mesh was pre-hydrated with saline solution for 3 seconds and implanted intra-abdominally with the barrier facing downward.The mesh was fixated circumferentially with a non-bard/davol fixation device placed approximately 1-2cm apart and secured with sutures.The hernia defect was closed primarily and the mesh overlap was 3.5cm.Following fixation, the positioning system was removed and the fascia was closed over the mesh.Post-implant, the patient developed abdominal pain, the surgeon originally believed it was pain from an incisional hernia and brought the patient back for hernia repair on (b)(6) 2020.Intraoperatively, the surgeon discovered an undiagnosed bowel obstruction at the site of dense adhesions/ingrowth of the bowel to the phasix st open mesh; the mesh was still mostly intact.A bowel resection was performed and the removed portion had a hardened feel, that the surgeon found very abnormal, and pieces of mesh were still adhered to the bowel.It is not known if the portion of bowel adhered to the mesh was, in fact, the site of the anastomosis.

• Brand Name: PHASIX ST OPEN PS
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10279812
• Report Number: 1213643-2020-06677
• Device Sequence Number: 2496194
• Product Code: OWT
• UDI-Device Identifier: 00801741163173
• UDI-Public: (01)00801741163173
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: 07/28/2020
• Device Catalogue Number: 1220011
• Device Lot Number: HUDR0599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/15/2020
• 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: 69 YR