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

Catalog Number	1193045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a patient with a history of retroperitoneal mass liposarcoma, was diagnosed with a recurrence of this cancer post implant of the phasix mesh.The cancer recurrence was at the retroperitoneum/pelvis site where the primary tumor was removed in the retroperitoneum (right radical nephrectomy).Therefore, the placement of the phasix mesh used for the laparotomy was likely not in proximity to cancer removed or the recurrence site.The clinician has assessed the cancer recurrence as being not related to the study device.Review of manufacturing records confirms product was manufactured to specification.To date, there have been no other reported complaints associated with this lot number released for distribution in may 2020.There is no indication that the condition is in any way related to the use of the phasix implant.An mdr is filed to document the event in an abundance of caution.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 clinical trial (b)(4): on (b)(6) 2021, the subject patient underwent an exploratory primary laparotomy performed with concomitant appendectomy, cholecystectomy, radical right sided nephrectomy (repair of diaphragmatic injury) during which a phasix mesh was trimmed and placed in an onlay fashion.The subject patient was discharged from the hospital on (b)(6) 2021.On (b)(6) 2022, the patient was diagnosed with cancer recurrence, and was started on chemotherapy and underwent re-operation on (b)(6) 2023.The patient required hospital stay for a period of one week.The cancer recurrence was assessed by the treating clinician or the clinical evidence review committee to be unrelated to the phasix study device used in the laparotomy repair.
Additional Manufacturer Narrative
As reported, a patient with a history of retroperitoneal mass liposarcoma, was diagnosed with a recurrence of this cancer post implant of the phasix mesh.The cancer recurrence was at the retroperitoneum/pelvis site where the primary tumor was removed in the retroperitoneum (right radical nephrectomy).Therefore, the placement of the phasix mesh used for the laparotomy was likely not in proximity to cancer removed or the recurrence site.The clinician has assessed the cancer recurrence as being not related to the study device.Review of manufacturing records confirms product was manufactured to specification.To date, there have been no other reported complaints associated with this lot number released for distribution in may 2020.There is no indication that the condition is in any way related to the use of the phasix implant.An mdr is filed to document the event in an abundance of caution.Addendum: h11: this supplemental mdr is submitted to document the correction in patient id.Updated fields: b4, g3, g6, h2, h10, h11 corrected field: a1 (patient identifier) 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 clinical trial dvl-he-018: on (b)(6) 2021, the subject patient underwent an exploratory primary laparotomy performed with concomitant appendectomy, cholecystectomy, radical right sided nephrectomy (repair of diaphragmatic injury) during which a phasix mesh was trimmed and placed in an onlay fashion.The subject patient was discharged from the hospital on (b)(6) 2021.On (b)(6) 2022, the patient was diagnosed with cancer recurrence, and was started on chemotherapy and underwent re-operation on (b)(6) 2023.The patient required hospital stay for a period of one week.The cancer recurrence was assessed by the treating clinician or the clinical evidence review committee to be unrelated to the phasix study device used in the laparotomy repair.

• 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: 17560138
• Report Number: 1213643-2023-00292
• Device Sequence Number: 3584161
• Product Code: OOD
• UDI-Device Identifier: 00801741107672
• UDI-Public: (01)00801741107672
• 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: 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): 08/22/2023

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: 02/28/2022
• Device Catalogue Number: 1193045
• Device Lot Number: HUEN1427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2020
• 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; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 96 KG