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U.S. Department of Health and Human Services

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

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LEMAITRE VASCULAR, INC. XENOSURE BIOLOGICAL PATCH MESH, SURGICAL Back to Search Results
Catalog Number UNKNOWN
Device Problem Calcified (1077)
Patient Problem Pain (1994)
Event Date 03/30/2017
Event Type  malfunction  
Manufacturer Narrative
We have not received the device for evaluation since the device has been analyzed and discarded by the hospital. Date of examination on the histology report was written as (b)(6) 2016 while the patch was explanted on (b)(6) 2017. So, we could not authenticate if the histology corresponds with the same patch from the reported incident. Follow up with the reporter has been unsuccessful in confirming sequence of events. No lot number or catalog number was provided. So, a batch record review of this reported patch could not be performed. This is the first reported incident of this kind and therefore considered to be an isolated incident. The patch was explanted and replaced with another patch. Patient has been discharged from the hospital.
 
Event Description
A xenosure bovine patch was used in the groin in (b)(6) 2016. In (b)(6) 2017, the patient complained about pain in the leg. So, the physician re-operated and removed the patch. According to the physician, the patch had transformed into a hard material. The explanted patch was sent to a histology lab for evaluation. A summary of the report was received on (b)(6) 2018 (14 months after explant of the patch) which reports ossification of the patch.
 
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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 Key7631447
MDR Text Key112447959
Report Number1220948-2018-00042
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeBE
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 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received05/23/2018
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: 06/22/2018 Patient Sequence Number: 1
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