• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX PORCINE SURGICAL MESH Back to Search Results
Catalog Number 1161935
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hernia (2240)
Event Date 11/14/2017
Event Type  Injury  
Event 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).
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXENMATRIX
Type of DevicePORCINE 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 Key15282767
MDR Text Key298477900
Report Number1213643-2022-00591
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00801741031441
UDI-Public(01)00801741031441
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2017
Device Catalogue Number1161935
Device Lot NumberHUZJ1745
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/24/2022 Patient Sequence Number: 1
-
-