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	Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	01/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged per clinical trial (b)(4): on (b)(6) 2015, the patient underwent an open first-time recurrent midline ventral hernia repair during which a xenmatrix surgical graft was trimmed and placed in underlay fashion, intra-peritoneally using open component separation technique (cst) method and was fixated using maxon sutures.The hernia site wound was noted to be a class ii (clean - contaminated) site.Fascia and full skin closure was achieved using vicryl interrupted stitch and staples.Concomitant procedures included lysis of adhesions, ostomy creation/revision/reversal and mucosa fistula takedown.The patient was discharged on (b)(6) 2015.As reported, the patient diagnosed with surgical site infection (ssi) on (b)(6) 2016 with purulent drainage from the superficial incision, was treated with oral antibiotics which resolved on (b)(6) 2016.Per the study clinician, the reported ae (surgical site infection (ssi)) has been assessed as mild in severity, possibly related to the study device and to the index procedure and has recovered/resolved.The reported ae does not meet the definition of an sae (serious adverse event).
Additional Manufacturer Narrative
As reported, post implant of the xenmatrix graft during a procedure that included, lysis of adhesions, ostomy creation/revision/reversal and mucosa fistula takedown ,the patient was diagnosed with a surgical site infection.The clinician has assessed the patient¿s postoperative course of surgical site infection as possibly related to the study device and to the procedure.However, based on the information provided, no conclusion can be made.Infection is a known inherent risk of surgery and is listed as a possible complication in the instructions-for-use (ifu) supplied with the device.Regarding infection, the warnings section of the ifu states, "if an infection develops, it should be treated aggressively." review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot released for distribution in october 2015.Not returned - remains implanted.

• 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: 15339983
• Report Number: 1213643-2022-00612
• Device Sequence Number: 20588162
• 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: 2015
• 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): 08/16/2022

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: 09/28/2017
• Device Catalogue Number: 1161935
• Device Lot Number: HUZJ1746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2015
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 97 KG