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

Catalog Number	1191025
Medical Device Problem Codes	Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per the clinical trial (b)(4): on (b)(6)2021 the subject patient underwent an open primary laparotomy epigastric aorto-mesenteric bypass during which a phasix mesh was trimmed and placed in onlay fashion using absorbable multifilament 3.0 vicryl sutures.The subject patient was discharged from the hospital on (b)(6)2021.On (b)(6)2021, the patient experienced abdominal pain, nausea and vomiting and was treated with medication.The reported adverse event (abdominal pain, nausea and vomiting) has been assessed per clinician as possibly related to the study device and definitely related to the procedure and recovered/resolved.The ae has been assessed as mild in severity.The reported ae does meet the definition of a sae (serious adverse event) and does meet the definition of uade (unanticipated adverse device event).
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.The reported adverse event (abdominal pain, nausea and vomiting) has been assessed per clinician as possibly related to the study device and definitely related to the procedure.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april 2020.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.
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.The reported adverse event (abdominal pain, nausea and vomiting) has been assessed per clinician as possibly related to the study device and definitely related to the procedure.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 28 units released for distribution in (b)(6) 2020.Addendum: this is an addendum to the initial mdr submitted, to document additional information provided.As reported, the initially reported patient symptoms (nausea, abdominal pain, vomiting) were found to be associated with the patient condition mesenteric ischemia, which has been assessed per the clinician as not related to the study device.Based on the additional information provided no patient adverse event occurred associated with the phasix mesh used to treat the patient.Updated fields: b4, b5, b7, g3, g6, h2, h6, h10.Corrected field: e3 (initial reporter occupation) 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 the clinical trial dvl-he-018: the subject patient had an open midline umbilical hernia repair surgery on (b)(6) 2011.The subject patient underwent an open primary laparotomy epigastric aorto-mesenteric bypass, during which a bard/davol phasix mesh onlay (cat no #1191025 and lot no # hudz2133) 4 x 10 rectangle (10 x 25 cm) was placed and secured in place with absorbable multifilament 3.0 vicryl sutures.The subject patient was admitted to the hospital on (b)(6) 2021.The surgery was done with trimming the phasix mesh and the midline fascia was completely closed.A 3cm overlap in all directions was achieved.Prophylactic antibiotic clindamycin were used perioperatively.Skin closure was achieved with long-term absorbable suture and surgical glue.The subject patient was discharged from the hospital on (b)(6) 2021.On (b)(6) 2021 - the patient diagnosed with abdominal pain, nausea and vomiting and was treated with medication.As reported, deviation from protocol defined procedure, ratio of suture: length for fascial closure did not fall within expected range.The reported adverse event (abdominal pain, nausea and vomiting) has been assessed per clinician as possibly related to the study device and definitely related to the procedure and recovered/resolved.The ae has been assessed as mild in severity.The reported ae does meet the definition of a sae (serious adverse event) and does meet the definition of uade (unanticipated adverse device event).Addendum per additional information received: it was reported that the patient was diagnosed with mesenteric ischemia on (b)(6) 2021, mild in severity and had required or prolonged hospitalization.It was reported that the ischemia was not related to the study device, possibly related to the procedure, recovered/resolved and does meet the definition of uade (unanticipated adverse device event).

• 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: 16899116
• Report Number: 1213643-2023-00185
• Device Sequence Number: 5497314
• Product Code: OOD
• UDI-Device Identifier: 00801741107580
• UDI-Public: (01)00801741107580
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 01/28/2022
• Device Catalogue Number: 1191025
• Device Lot Number: HUDZ2133
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2020
• 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: Female
• Patient Weight: 42 KG