MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX ST MESH; SURGICAL MESH

Catalog Number	1201520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Inflammation (1932)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent a robotic low anterior resection of the rectum with implant of phasix st at pelvic inlet on (b)(6) 2021.Absorbable v-loc suture was used to sew the mesh with seprafilm side toward the abdomen and non-seprafilm side toward pelvis.On (b)(6) 2024, patient underwent a hand-assisted lap small bowel resection (x2) with associated takedown of enterovaginal fistula, incidental appendectomy, end colostomy revision and residual mesh was found within the fistula track.Surgeon reports the mesh did not absorb fast enough, created inflammation causing adherence to mesh and vaginal cuff.It was reported that patient is now stable and was discharged.
Additional Manufacturer Narrative
As reported, the patient had enterovaginal fistula, inflammation, adhesion about 2 years 7 months post implant of phasix st mesh thereby underwent repair.Based on the information provided, no conclusion can be made as to the degree to which the device, may have caused or contributed to the patient¿s reported clinical course.Fistula, inflammation and adhesion are known inherent risk of the surgery and are listed as possible complications in the adverse reaction section of the instructions for use (ifu) supplied with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note: section a through f - the information provided by bd 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 bd.H3 other text: device not returned.

• Brand Name: PHASIX ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 19330024
• Report Number: 1213643-2024-00259
• Device Sequence Number: 20560707
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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 Catalogue Number: 1201520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female