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

MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. XENOSURE BIOLOGICAL PATCH MESH, SURGICAL

  • 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
 

LEMAITRE VASCULAR, INC. XENOSURE BIOLOGICAL PATCH MESH, SURGICAL Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Seroma (2069); Pseudoaneurysm (2605)
Event Type  Injury  
Manufacturer Narrative
The initial report indicated that this facility has experienced higher rates of seroma formation. They further report that the xenosure device used in the carotid artery application does not yield these issues. Doctor also confirmed that they do not use any surgical drains to prevent seroma formation. Although the investigation is ongoing, our initial investigation has determined that the xenosure device is not likely a contributor to these issues - particularly when considering the patch's continued use by this institution in other vascular beds, without any similar complications. We analyzed our complaint records for similar series or singular incidents and have found no patch related issues for seroma or post-operative bleeding. Therefore, our current rate of occurrence for these types of events remains within our expected rates as analyzed through our risk analysis documentation. We presented this case to our medical director who has extensive experience with bovine pericardial patches. Upon review of this case information, he believed that the xenosure patch was not a contributor to these issues. He believes that the issue is more likely related to the surgeon' s technique during suturing the patch and/or weakness of the arterial wall. He further comment that it is not uncommon that there will be a seroma or some other drainage problem based on lymphatic drainage normally more prevalent in the femoral inguinal groin as opposed to other sites in the body. Our ifu clearly/appropriately warns the users about the risks that could occur with the use of the xenosure patch. It is highly unlikely that the patch contributed to this incident.
 
Event Description
No specific incident was referenced. During casual conversation, surgeon expressed that she experienced an increased rate of postoperative seroma formation in some patients and late postoperative bleeding 14-30 days after the index procedure in others.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXENOSURE BIOLOGICAL PATCH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LEMAITRE VASCULAR, INC.
63 second ave
burlington MA 01803
Manufacturer (Section G)
LEMAITRE VASCULAR, INC.
63 second ave
burlington MA 01803
Manufacturer Contact
pragya thikey
63 second ave
burlington, MA 01803
7812212266
MDR Report Key7328757
MDR Text Key102066880
Report Number1220948-2018-00010
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K040835
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/09/2018 Patient Sequence Number: 1
-
-