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

Catalog Number	1191530
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, we are unable to determine to what extent, if any, the phasix mesh may have caused or contributed to the patient's postoperative seroma.Seroma formation is a known inherent risk of surgery.As reported, the seroma was drained during postoperative follow ups and was resolving.The seroma was clinically assessed to be related to the procedure and not to the study device.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october, 2019.The instructions-for-use (ifu) supplied with the device lists seroma as a possible complication.Not returned - remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced a seroma.On (b)(6) 2020: the subject patient underwent an open midline laparotomy for aorto celiac mesenteric artery bypass, with placement of a 6¿x12¿ rectangle (15x30 cm) phasix mesh (cat #1191530, lot #hudu0528).A 30 cm incision from the xyphoid to the pubis was made, the phasix mesh was trimmed to 13 x 30 cm and placed in onlay fashion.A minimum of 3cm overlap was achieved in all directions of the incision site (class i, clean wound).Perimeter fixation of the mesh was achieved by using 30 sorbafix fasteners, placed 2cm apart.Non-bard/davol sutures placed 2cm apart (1-pds) were used for fascia and skin closure.The patient was administered clindamycin perioperatively.On (b)(6) 2020: the patient was discharged to home.On (b)(6) 2020: the subject patient was diagnosed with a seroma.The ae was assessed as not related to the study device and definitely related to the index procedure.The seroma was assessed to be of moderate severity and not resolved.On (b)(6) 2020: the subject patient's seroma was reported to have worsened; 420ml of fluid in the periumbilical region was aspirated by the pi with no indications of infection or hernia.The ae was assessed as severe and not resolved.On (b)(6) 2020: the patient again presented with worsening seroma; 330ml of fluid in the periumbilical region was aspirated.The ae was assessed as severe and resolving; with no action taken with the study device.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced a seroma.(b)(6) 2020: the subject patient underwent an open midline laparotomy for aorto celiac mesenteric artery bypass, with placement of a 6¿x12¿ rectangle (15x30 cm) phasix mesh (cat #1191530, lot #hudu0528).A 30 cm incision from the xyphoid to the pubis was made, the phasix mesh was trimmed to 13 x 30 cm and placed in onlay fashion.A minimum of 3cm overlap was achieved in all directions of the incision site (class i, clean wound).Perimeter fixation of the mesh was achieved by using 30 sorbafix fasteners, placed 2cm apart.Non-bard/davol sutures placed 2cm apart (1-pds) were used for fascia and skin closure.The patient was administered clindamycin perioperatively.(b)(6) -2020: the patient was discharged to home.(b)(6) 2020: the subject patient was diagnosed with a seroma.The ae was assessed as not related to the study device and definitely related to the index procedure.The seroma was assessed to be of moderate severity and not resolved.(b)(6) 2020: the subject patient's seroma was reported to have worsened; 420ml of fluid in the periumbilical region was aspirated by the pi with no indications of infection or hernia.The ae was assessed as severe and not resolved.(b)(6) 2020: the patient again presented with worsening seroma; 330ml of fluid in the periumbilical region was aspirated.The ae was assessed as severe and resolving; with no action taken with the study device.Addendum: the ae has been assessed by the clinician as likely related to the study device and likely related to the index procedure.
Additional Manufacturer Narrative
Based on the information provided, we are unable to determine to what extent, if any, the phasix mesh may have caused or contributed to the patient's postoperative seroma.Seroma formation is a known inherent risk of surgery.As reported, the seroma was drained during postoperative follow ups and was resolving.The seroma was clinically assessed to be related to the procedure and not to the study device.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october, 2019.The instructions-for-use (ifu) supplied with the device lists seroma as a possible complication.This is an addendum to the initial emdr to document corrected information.This corrected information states the seroma has been assessed by the clinician as likely related to the study device and likely related to the index procedure.Not returned - remains implanted.

• 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: 10513280
• Report Number: 1213643-2020-08140
• Device Sequence Number: 14153909
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 08/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDU0528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: 77 YR