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 Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Hernia (2240)
Date of Event	04/29/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of the xenmatrix, the patient was diagnosed with deep surgical site infection, wound dehiscence and hernia recurrence and underwent reoperation for mesh removal.The clinician has assessed the patient¿s postoperative course as "possibly" related related to the study device and possibly related to the procedure.However, based on the information provided, no conclusion can be made.Hernia recurrence and infection are known inherent risk of surgery.The instructions-for-use (ifu) supplied with the device lists hernia recurrence and infection as a possible complication.Review of manufacturing records confirms product was manufactured to specification.In regards to infection, the warnings section of the ifu states, " if an infection develops, it should be treated aggressively.".
Event or Problem Description
Alleged per clinical trial dvl-he-020: on (b)(6) 2014 the subject patient underwent multiple recurrent ventral midline open hernia repair procedure during which a xenmatrix surgical graft was trimmed and placed in underlay fashion through bridging placement using open component separation technique (cst) method, fixated using sutures and fascia closure was not achieved due to bridging mesh.Full skin closure was achieved using sutures.The patient was discharged on (b)(6) 2014.Concomitant procedures include panniculectomy, lysis of adhesion(s), hysterectomy.On (b)(6) 2014 , the subject patient was diagnosed with deep surgical site infection and was treated with intravenous antibiotics/antimicrobials medication.On (b)(6) 2014, the subject patient was diagnosed with ventral midline hernia and underwent additional surgery.The graft was removed due to deep surgical site infection and wound dehiscence, the patient also underwent excisional debridement of abdominal wall and skin was fully closed by wound vac method.The patient was discharged on (b)(6) 2014.About a year later, the wound was eventually closed after split thickness in skin.The ae is clinically assessed to be of moderate severity, possibly related to the study device and 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 definition of uade (unidentified adverse device 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: 15181885
• Report Number: 1213643-2022-00574
• Device Sequence Number: 5905974
• 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: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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
• Report Date (Section B): 07/19/2022

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: 10/02/2015
• Device Catalogue Number: 1161935
• Device Lot Number: HUXI1698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 163 KG