MAUDE Adverse Event Report: BARD SHANNON LIMITED -3005636544 PHASIX MESH; SURGICAL MESH

Catalog Number	1191530
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient underwent a procedure due to pancreatic cancer and at that time was implanted with a phasix mesh.Following surgery, the patient was diagnosed with bowel obstruction.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device, however, based on the information provided, no conclusion can be made.Review of manufacturing records shows the 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.Not returned.Remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced bowel obstruction post implant of the phasix mesh.On (b)(6) 2021, the subject patient underwent an exploratory laparotomy to perform a whipple procedure (pancreaticduodenectomy) due to a medical history significant for cancer (malignant neoplasm of head of pancreas).During this procedure a bard/davol phasix mesh was placed in an onlay fashion and mechanical fixation (non-bard/davol) was achieved to secure the mesh.A cholecystectomy was also performed at this time.On (b)(6) 2021, the patient was discharged from the hospital to home with nursing care.(b)(6) 2021, the patient presented to the emergency department and was diagnosed with bowel obstruction.As reported, the reported ae of bowel obstruction has been assessed per the clinician as definitely related to the study device and not related to the index procedure and moderate in severity.
Additional Manufacturer Narrative
As reported, the patient underwent a procedure due to pancreatic cancer and at that time was implanted with a phasix mesh.Following surgery, the patient was diagnosed with bowel obstruction.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device, however, based on the information provided, no conclusion can be made.Review of manufacturing records shows the product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the additional information provided.Based on the received information, the reported ae of bowel obstruction has been assessed per the clinician as not related to the study device and definitely related to the procedure.Updated fields: b4, b5, g3, g6, h2, h6, h10.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.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced bowel obstruction post implant of the phasix mesh.(b)(6) 2021 - the subject patient underwent an exploratory laparotomy to perform a whipple procedure (pancreaticduodenectomy) due to a medical history significant for cancer (malignant neoplasm of head of pancreas).During this procedure a bard/davol phasix mesh was placed in an onlay fashion and mechanical fixation (non-bard/davol) was achieved to secure the mesh.A cholecystectomy was also performed at this time.(b)(6) 2021 - the patient was discharged from the hospital to home with nursing care.(b)(6) 2021 - the patient presented to the emergency department and was diagnosed with bowel obstruction.As reported, the reported ae of bowel obstruction has been assessed per the clinician as definitely related to the study device and not related to the index procedure and moderate in severity.Addendum: the reported ae of bowel obstruction has been assessed per the clinician as not related to the study device and definitely related to the procedure.The ae has been assessed as moderate in severity and also assessed to meet the definition of a sae (serious adverse event).The reported ae does not meet the definition of a uade (unanticipated adverse device event).

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• 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: 12656049
• Report Number: 1213643-2021-20365
• Device Sequence Number: 16471104
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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 Expiration Date: 11/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDX2670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 100 KG