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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

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LEMAITRE VASCULAR, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT Back to Search Results
Model Number AG750
Device Problem Material Puncture/Hole (1504)
Patient Problem Hematoma (1884)
Event Date 05/19/2021
Event Type  malfunction  
Manufacturer Narrative
We have not received the graft for evaluation since the graft remains implanted.Hence, we could not conclusively determine the cause of the failure.As this is a known possible issue, instructions for use include instructions for pressure testing each graft prior to implant.The preparation for implant section states, "artegraft is manometry pressure tested and quality inspected.Before implanting, occlude one end of graft and pressure test with syringe filled with saline solution." the preimplant pressure test required per the ifu was performed by the customer and did not identify any leaks with the graft.As the pre-implant pressure test did not identify any leaks and the graft was implanted for 23 days prior to the issue, it is likely that the issue was caused after the implant procedure.All grafts released from batch 21b048 passed the requirements for release, including pressure testing, sterility testing, and final visual inspection prior to release to finished goods.To date, no additional complaints were reported from this product batch.Based on our investigation this appears to be an isolated incident.All product quality and clinical issues will continue to be monitored within quality assurance trending.
 
Event Description
The graft was implanted on (b)(6) 2021 femoral to popliteal bypass procedure.No issues occurred during the procedure.The malfunction was detected on (b)(6) 2021.This graft was not used for access.The patient was bleeding out through a hole in the graft about 6cm south of proximal anastomosis.The surgeon surgically repaired the hole with ptfe.The patient was reported as "doing fine" after the procedure.
 
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Brand Name
ARTEGRAFT
Type of Device
COLLAGEN VASCULAR GRAFT
Manufacturer (Section D)
LEMAITRE VASCULAR, INC.
206 north center drive
north brunswick NJ 08902 4247
Manufacturer (Section G)
LEMAITRE VASCULAR, INC.
206 north center drive
north brunswick NJ 08902 4247
Manufacturer Contact
cynthia salter
206 north center drive
north brunswick, NJ 08902-4247
7324228333
MDR Report Key11952288
MDR Text Key264092676
Report Number2247686-2021-00004
Device Sequence Number1
Product Code LXA
UDI-Device Identifier00316837000312
UDI-Public(01)00316837000312(11)210323(17)240228(10)21B048-007(91)AG750
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N16837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial
Report Date 06/07/2021
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? Yes
Device Operator No Information
Device Expiration Date02/28/2024
Device Model NumberAG750
Device Catalogue NumberAG 750
Device Lot Number21B048-007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/19/2021
Initial Date FDA Received06/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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