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

Catalog Number	1192040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Seroma (2069); Drug Resistant Bacterial Infection (4553)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per prevent clinical trial (b)(4): on (b)(6) 2022, the subject patient underwent primary laparotomy-open aortoiliac bypass during which a phasix mesh was trimmed and secured in place with 2-0 pds sutures.Prophylactic antibiotic cefazolin was used perioperatively.On (b)(6) 2022, the patient was diagnosed with seroma and was admitted on the same day.It was reported that the patient required ir placed drain.Fluid cultures of seroma were negative.During this stay the patient was diagnosed with wound dehiscence.The adverse event of seroma was assessed per clinician as moderate severity, possibly related to the study device, and definitely related to the procedure and recovering/resolving.The wound dehiscence was assessed per clinician as moderate severity moderate severity and not recovered/not resolved.The adverse event has been assessed as a serious adverse event (sae) and the event does not meet the definition of an unanticipated adverse device effect (uade).
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a seroma and wound dehiscence post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of seroma as possibility related to the study device and definitely related to the index procedure.Seroma and wound dehiscence are known inherent risks of surgery and are listed in the adverse reactions section of the instructions-for-use, supplied with the device, as possible complications.Not returned - remains implanted.
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a seroma and wound dehiscence post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of seroma as possibility related to the study device and definitely related to the index procedure.Seroma and wound dehiscence are known inherent risks of surgery and are listed in the adverse reactions section of the instructions-for-use, supplied with the device, as possible complications.Addendum: this supplemental mdr is submitted to report additional information provided.No conclusions can be made.As reported, the patient was diagnosed with an infected abdominal wall abscess post implant of the phasix mesh.This appears to be a cascading from the postoperative seroma.The clinician has assessed the abscess as possibly related to the study device and definitely related to the index procedure.Review of manufacturing records confirms product was manufactured to specification.Infection 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.The warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device".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 - remains implanted.
Event or Problem Description
As reported per prevent clinical trial dvl-he-018: on (b)(6) 2022, the subject patient underwent primary laparotomy-open aortoiliac bypass during which a phasix mesh was trimmed and secured in place with 2-0 pds sutures.Prophylactic antibiotic cefazolin was used perioperatively.On (b)(6) 2022, the patient was diagnosed with seroma and was admitted on the same day.It was reported that the patient required ir placed drain.Fluid cultures of seroma were negative.During this stay the patient was diagnosed with wound dehiscence.The adverse event of seroma was assessed per clinician as moderate severity, possibly related to the study device, and definitely related to the procedure and recovering/resolving.The wound dehiscence was assessed per clinician as moderate severity moderate severity and not recovered/not resolved.The adverse event has been assessed as a serious adverse event (sae) and the event does not meet the definition of an unanticipated adverse device effect (uade).Addendum per additional information received: on (b)(6) 2023, the patient was diagnosed with abdominal wall abscess and was admitted on the same day.The abscess culture tested positive for a drug resistant bacteria.It was reported that this adverse event has been assessed per clinician as severe, possibly related to the study device and definitely related to the procedure and not recovered/not resolved.The adverse event has been assessed as a serious adverse event (sae) and the event does meet the definition of uade.

• 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: 16210134
• Report Number: 1213643-2023-00003
• Device Sequence Number: 4454100
• Product Code: OOD
• UDI-Device Identifier: 00801741107634
• UDI-Public: (01)00801741107634
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 10/28/2023
• Device Catalogue Number: 1192040
• Device Lot Number: HUFY0753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female