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

Catalog Number	1151015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for-use, supplied with the device, as a possible complication.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 december 2015.
Event or Problem Description
As reported per fda: during a surgical procedure on (b)(6) 2016, the patient was implanted with xenmatrix ab.As reported, the patient started feeling symptoms like poor bowel movement which he addressed with his primary care doctor on (b)(6) 2022.This led to surgery at another hospital as the doctor had found 2 hernias during an examination.Surgery was performed, and the doctor placed a medical patch over the device.
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for-use, supplied with the device, as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 53 units released for distribution in (b)(6) 2015.Addendum: h11: this supplemental mdr is submitted to report additional and corrected information provided.Based on the information provided it appears the patient had experienced a recurrence of this right inguinal hernia prior to the implant of the xenmatrix ab graft.The initial determination remains the same, no conclusions can be made as to the degree to which the xenmatrix ab graft caused or contributed to the patient¿s hernia recurrence.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 fda: during a surgical procedure on (b)(6) 2016, the patient was implanted with xenmatrix ab.As reported, the patient started feeling symptoms like poor bowel movement which he addressed with his primary care doctor on (b)(6) 2022.This led to surgery at another hospital as the doctor had found 2 hernias during an examination.Surgery was performed, and the doctor placed a medical patch over the device.Addendum per additional information provided: (b)(6) 2016 - per surgical case record provided the patient underwent a procedure during which removal of right inguinal mesh was performed and the patient was implanted with a xenmatrix ab graft.(b)(6) 2022 -the patient was diagnosed with recurrent right inguinal hernia and underwent robotic assisted right inguinal hernia repair with 3dmax mesh implant.

• Brand Name: XENMATRIX AB
• Common Device Name: PORCINE 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: 16009867
• Report Number: 1213643-2022-00805
• Device Sequence Number: 5784026
• Product Code: PIJ
• UDI-Device Identifier: 00801741074226
• UDI-Public: (01)00801741074226
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 11/28/2017
• Device Catalogue Number: 1151015
• Device Lot Number: HUZK0560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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
• Patient Age: 70 YR
• Patient Sex: Male