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

Catalog Number	1191530
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Necrosis (1971); Seroma (2069)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, one month post-implant of the phasix mesh, the patient experienced a postoperative seroma.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device and not related to the index procedure, however, based on the information provided, no conclusion can be made.Seroma is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Should additional information be provided, a supplemental mdr will be submitted.
Event or Problem Description
As reported per prevent clinical trial (b)(4): on (b)(6) 2021, the subject patient underwent an open primary laparotomy to perform a whipple procedure with the implant of the bard/davol phasix mesh, placed in onlay fashion.The phasix mesh was trimmed and adequate overlap of the defect was achieved.Mechanical fixation was used (bard/davol sorbafix) to fixate the mesh with 16 fixation points spaced 3cm apart.The midline fascia was completely closed with non-bard/davol, 1pds slow absorbing monofilament suture in a running stitch technique.A skin closure was achieved with long-term absorbable suture in a running stitch.It was reported that on (b)(6) 2021, the subject patient was discharged.As reported, the subject patient was diagnosed with a postoperative seroma during an office visit on (b)(6) 2021.Based on the patient description, wound leakage "most-consistent" with a seroma and fat necrosis that has decompressed spontaneously (without treatment).At this time the clinician indicates there is no concern for infection and the area is expected to close in the next 3-5 days.The reported adverse event has been assessed by the clinician to be definitely related to the study device and not related to the procedure, with a classified severity of mild.As reported, this ae of post-operative seroma does not meet the definition of an sae (serious adverse event) or uade (unanticipated adverse device event).
Event or Problem Description
As reported per prevent clinical trial dvl-he-018: on (b)(6) 2021, the subject patient underwent an open primary laparotomy to perform a whipple procedure with the implant of the bard/davol phasix mesh, placed in onlay fashion.The phasix mesh was trimmed and adequate overlap of the defect was achieved.Mechanical fixation was used (bard/davol sorbafix) to fixate the mesh with 16 fixation points spaced 3cm apart.The midline fascia was completely closed with non-bard/davol, 1pds slow absorbing monofilament suture in a running stitch technique.A skin closure was achieved with long-term absorbable suture in a running stitch.It was reported that on (b)(6) 2021, the subject patient was discharged.As reported, the subject patient was diagnosed with a postoperative seroma during an office visit on (b)(6) 2021.Based on the patient description, wound leakage "most-consistent" with a seroma and fat necrosis that has decompressed spontaneously (without treatment).At this time the clinician indicates there is no concern for infection and the area is expected to close in the next 3-5 days.The reported adverse event has been assessed by the clinician to be definitely related to the study device and not related to the procedure, with a classified severity of mild.As reported, this ae of post-operative seroma does not meet the definition of an sae (serious adverse event) or uade (unanticipated adverse device event).Addendum per additional information: on (b)(6) 2021, the subject patient was diagnosed with a wound dehiscence and mesh exposure.As reported, the patient underwent an irrigation and debridement on (b)(6) 2021 and 90% of the mesh was removed as it was nonincorporated.As reported, the reoperation was not performed through the initial index procedure fascial incision.A wound vac was placed wet to dry and the patient was discharged from the hospital on (b)(6) 2021.The reported adverse event has been assessed by the clinician to be moderate in severity and definitely related to both the study device and the index procedure.
Additional Manufacturer Narrative
As reported, one month post-implant of the phasix mesh, the patient experienced a postoperative seroma.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device and not related to the index procedure, however, based on the information provided, no conclusion can be made.Seroma is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum: h11.This is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the additional information provided.Based on the additional information provided, the patient was diagnosed with a wound dehiscence and underwent mesh explant.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to both the study device and the index procedure.The additional details provided do not change the initial determination, no conclusion can be made.Wound dehiscence is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device as a possible complication.Should additional information be provided, a supplemental mdr will be submitted.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 : not returned - mesh explanted.

• Brand Name: PHASIX 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: 12953916
• Report Number: 1213643-2021-20452
• Device Sequence Number: 14660119
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: 12/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDY1470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 98 KG