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

Catalog Number	1152025
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Local Reaction (2035); Seroma (2069); Reaction (2414)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced fluid collection and a possible reaction post-implant of the bard/davol xenmatrix ab graft.Per the surgeon, the patient is doing well and no additional surgical intervention is required at this time.Seroma formation is a known inherent risk of surgery.Seroma and allergic reaction are identified as potential complications in the adverse reaction section of the instructions-for-use.Based on the information provided to date, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient¿s reported symptoms.To date, this is the only reported complaint for this manufacturing lot.Should additional information be provided, a supplemental mdr will be submitted.This mdr represents the bard/davol xenmatrix ab graft (device #2).An additional mdr was previously submitted for bard/davol xenmatrix ab graft, 1213643-2020-06079 (device #1).Note: combination device.Minocycline and rifampin antibacterial agents implant coating is intended to, and shown in preclinical studies, to reduce bacterial colonization of the device, not intended (claimed) to act as a systemic drug.Not returned - remains implanted.
Event or Problem Description
It was reported that a female patient was implanted with a bard/davol xenmatrix ab graft on (b)(6) 2020 after which the patient experienced post-op fluid development and underwent a partial explant, about 6 months ago.As reported, though the surgeon had re-operated (date unknown) and placed another bard/davol xenmatrix ab graft, the patient experienced the same postoperative symptoms of fluid development and drainage.The surgeon suspects the patient to have an allergic reaction against a component of the graft.The patient was doing well with no additional surgical treatment planned and will be monitored by the surgeon at this time.
Additional Manufacturer Narrative
As reported, the patient experienced fluid collection and a possible reaction post-implant of the bard/davol xenmatrix ab graft.Per the surgeon, the patient is doing well and no additional surgical intervention is required at this time.Seroma formation is a known inherent risk of surgery.Seroma and allergic reaction are identified as potential complications in the adverse reaction section of the instructions-for-use.Based on the information provided to date, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient¿s reported symptoms.To date, this is the only reported complaint for this manufacturing lot.Note: combination device.Minocycline and rifampin antibacterial agents implant coating is intended to, and shown in preclinical studies, to reduce bacterial colonization of the device, not intended (claimed) to act as a systemic drug.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the lot numbers for ab components used in the manufacture of the xenmatrix ab graft.A review of the manufacturing records which included a review of the ab components (rifampin and minocycline) was performed and found that the lot was manufactured to specification.This supplemental mdr was submitted to represent the bard/davol xenmatrix ab graft (device #2).An additional mdr was previously submitted for bard/davol xenmatrix ab graft, 1213643-2020-06079 (device #1).Should additional information be provided, a supplemental mdr will be submitted.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
It was reported that a female patient was implanted with a bard/davol xenmatrix ab graft on (b)(6) 2020 after which the patient experienced post-op fluid development and underwent a partial explant, about 6 months ago.As reported, though the surgeon had re-operated (date unknown) and placed another bard/davol xenmatrix ab graft, the patient experienced the same postoperative symptoms of fluid development and drainage.The surgeon suspects the patient to have an allergic reaction against a component of the graft.The patient was doing well with no additional surgical treatment planned and will be monitored by the surgeon at this time.

• 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
• MDR Report Key: 11342882
• Report Number: 1213643-2021-20024
• Device Sequence Number: 5036154
• Product Code: PIJ
• UDI-Device Identifier: 00801741074288
• UDI-Public: (01)00801741074288
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 1152025
• Device Lot Number: HUDZ1894
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention