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

Catalog Number	1161928
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Seroma (2069)
Date of Event	12/31/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of the xenmatrix graft, the patient was diagnosed with superficial wound dehiscence and subsequent seroma.The clinician has assessed the patient¿s postoperative course as definitely related to the study device, and possibly related to the procedure.However, based on the information provided, no conclusion can be made.Review of the manufacturing records shows the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 2014.Seroma is a known inherent risk of surgery and is listed as a possible complication in the instructions- for-use supplied with the device.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.Not returned - remains implanted.
Event or Problem Description
Alleged per clinical trial (b)(4): on (b)(6) 2014, the patient underwent multiple recurrent ventral midline open hernia repair procedure during which a xenmatrix surgical graft was trimmed and placed in underlay fashion, fixated using maxon sutures.Fascia was completely closed using maxon suture through interrupted stitch and full skin closure was achieved using sutures.Concomitant procedure included panniculectomy and lysis of adhesion(s).The patient was discharged home on (b)(6) 2014.On (b)(6) 2014, the patient was diagnosed with superficial wound dehiscence which resolved on (b)(6) 2015.The ae (wound dehiscence) is clinically assessed to be of mild severity, definitely related to the study device, possibly related to the procedure and recovered/resolved.The reported adverse event does not meet the definition of an sae (serious adverse event).On (b)(6) 2015, the patient was diagnosed with seroma and hospitalized on (b)(6) 2015.On (b)(6)2015 patient underwent a surgery for the seroma.Fascia was completely closed using vicryl suture through interrupted stitch and full skin closure was achieved.The patient was discharged home the same day.The ae (seroma) is clinically assessed to be of moderate severity, definitely related to the study device, possibly related to the procedure and recovered/resolved.The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the uade (unanticipated adverse device effects).

• 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: 15234615
• Report Number: 1213643-2022-00584
• Device Sequence Number: 4900165
• Product Code: FTM
• UDI-Device Identifier: 00801741031434
• UDI-Public: (01)00801741031434
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: 05/28/2016
• Device Catalogue Number: 1161928
• Device Lot Number: HUYD1099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 128 KG