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	Fistula (1862)
Date of Event	12/31/2014
Type of Reportable Event	Malfunction
Event or Problem Description
Reported per clinical trial (b)(4): on (b)(6) 2014, the patient underwent multiple recurrent ventral suprapubic open hernia repair procedure during which a xenmatrix surgical graft was trimmed and placed in underlay fashion inter peritoneally, fixated using a suture.Fascia was completely closed using vicryl suture through interrupted stitch.Full skin closure was achieved using sutures.Concomitant procedure includes lysis of adhesion(s).The patient was discharged to home on (b)(6) 2014.On (b)(6) 2014, the patient underwent removal of jackson pratt drain.The patient was discharged on the same day.On (b)(6) 2014, the patient was diagnosed with fistula; the spontaneous draining sinus resolved over time (b)(6) 2015).The ae is clinically assessed to be of mild severity, possibly related to the study device, not 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, patient underwent physical exam during which ventral suprapubic hernia (3.7 cm2) was diagnosed and confirmed through ct scan on (b)(6) 2015.On (b)(6) 2015 patient underwent an additional surgery and the device was explanted.
Additional Manufacturer Narrative
As reported, about three months post implant of xenmatrix, the patient was diagnosed with fistula which resolved with no treatment required.The clinician has assessed the patient¿s postoperative course as "possibly" related to the study device and not related to the procedure.However, based on the information provided, no conclusion can be made.The instructions-for-use supplied with the device lists fistula as a possible complication.Review of manufacturing records confirms product was manufactured to specification.This mdr represent the event of fistula.An additional mdr was submitted to represent the ae of hernia recurrence.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: 15188328
• Report Number: 1213643-2022-00577
• Device Sequence Number: 12214529
• 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: 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): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2016
• Device Catalogue Number: 1161935
• Device Lot Number: HUYD1101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• 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: Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 87 KG