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

Catalog Number	1161935
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/05/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged per clinical trial dvl-he-020: on (b)(6) 2013, the subject patient underwent multiple recurrent open ventral midline hernia repair, during which a bard/davol xenmatrix surgical graft was placed in sublay fashion on the retro-muscular region with suture.Fascia was completely closed with suture and full closure was achieved with sutures.Concomitant procedure includes lysis of adhesion(s), bowel resection and removal of previous mesh.The patient was discharged to home on (b)(6) 2013.On (b)(6) 2014, the patient was diagnosed with chronic seroma cavity.On (b)(6) 2014, the patient underwent an open ventral midline hernia procedure for seroma and the surgical graft was removed.Fascia was completely closed with suture and full closure was achieved.The patient was discharged to home on (b)(6) 2014.As reported, the adverse event has been resolved on (b)(6) 2014.This ae is clinically assessed to be possibly related to the study device and definitely related to the procedure.This has been assessed as a non-serious adverse event of moderate severity and has resolved.This reported adverse event does not meet the definition of an sae (serious adverse event).
Additional Manufacturer Narrative
As reported, about 5 months post-implant of the xenmatrix, the patient was diagnosed with chronic seroma and underwent mesh explant.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.Seroma formation is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use supplied with the device lists seroma 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 20 units released for distribution in (b)(6) 2013.
Additional Manufacturer Narrative
As reported, about 5 months post-implant of the xenmatrix, the patient was diagnosed with chronic seroma and underwent mesh explant.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.Seroma formation is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use supplied with the device lists seroma 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 may, 2013.Addendum: h.11: this is an addendum to the initial mdr submitted.This supplemental mdr has been submitted to remove the patient date of birth which was incorrectly documented in the initial mdr.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 - mesh explanted.
Event or Problem Description
Alleged per clinical trial (b)(6): on (b)(6) 2013, the subject patient underwent multiple recurrent open ventral midline hernia repair, during which a bard/davol xenmatrix surgical graft was placed in sublay fashion on the retro-muscular region using a non-bard/davol suture (maxon).Fascia was completely closed with non-bard/davol maxon suture in figure 8 technique and full closure was achieved with sutures.The patient was discharged to home on (b)(6) 2013.Concomitant procedure includes lysis of adhesion(s), bowel resection and removal of previous mesh.On (b)(6) 2014, the patient was diagnosed with chronic seroma cavity.On (b)(6) 2014, the patient underwent an open ventral midline hernia procedure for seroma and the surgical graft was removed.The patient was discharged to home on (b)(6) 2014.Fascia was completely closed with non-bard/davol maxon suture in figure 8 technique and full closure was achieved.As reported, the adverse event has been resolved on (b)(6) 2014.This ae is clinically assessed to be possibly related to the study device and definitely related to the procedure.This has been assessed as a non-serious adverse event of moderate severity and has resolved.This reported adverse event does not meet the definition of an sae (serious adverse event).

• Brand Name: XENMATRIX
• 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: 14988196
• Report Number: 1213643-2022-00509
• Device Sequence Number: 13852200
• Product Code: FTM
• UDI-Device Identifier: 00801741031441
• UDI-Public: (01)00801741031441
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 05/28/2015
• Device Catalogue Number: 1161935
• Device Lot Number: HUXC1979
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2013
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 97 KG