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	Hernia (2240)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2015, the patient underwent primary open midline ventral hernia repair during which xenmatrix surgical graft (device #1) was trimmed and placed using underlay technique in intra-peritoneal region and fixated using sutures.Full skin closure was achieved using maxon sutures with interrupted stitch.The patient was discharged on (b)(6) 2015.As reported, the patient was diagnosed with wound dehiscence on (b)(6) 2015 and admitted in the hospital.On (b)(6) 2015, the patient underwent surgery for wound dehiscence and given iv antibiotics, debridement, wound care and wound vac was placed.The patient was discharged on (b)(6) 2015.As reported, the patient was diagnosed with enterocutaneous fistula on (b)(6) 2015 and admitted in the hospital.As reported the patient was treated with tpn (total parenteral nutrition).The patient was discharged on (b)(6) 2015.As reported, on (b)(6) 2015 the patient was diagnosed with midline ventral hernia recurrence and ec fistula.As reported, the patient underwent surgery for hernia recurrence, wound dehiscence & fistula on (b)(6) 2015 during which another xenmatrix surgical graft, (device #2) was implanted and fixated using sutures and the previously implanted xenmatrix mesh (device #1) was removed (100%) and also fistulotomy occurred at the same time.The patient was discharged to home on (b)(6) 2015.As reported on (b)(6) 2017 the patient was diagnosed with midline small ventral hernia recurrence (device #2).The patient decided not to surgically treat at that time.The patient returned a year later and decided to repair again and underwent ct scan on (b)(6) 2018.Per the study clinician, the reported ae (hernia recurrence, device #2) has been assessed as mild in severity, possibly to the study device and not related to the index procedure and not recovered/not resolved.The reported ae does not meet the definition of serious (sae).
Additional Manufacturer Narrative
As reported, post implant of the xenmatrix, the patient was diagnosed with a recurrent hernia.The clinician has assessed the patient¿s postoperative course of hernia recurrence as possibly related to the study device and not related to the procedure.However, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of surgery and listed as a possible complication in the instructions-for-use (ifu) supplied with the device.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 4 units released for distribution in oct, 2015.This mdr represent the ae of hernia recurrence for the xenmatrix (device #2).An additional mdr was submitted to represent the ae of hernia recurrence, wound dehiscence & fistula for the xenmatrix (device #1).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: 15282767
• Report Number: 1213643-2022-00591
• Device Sequence Number: 15245473
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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: HUZJ1745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/24/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 79 KG