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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM Back to Search Results
Model Number 5F051503CS
Medical Device Problem Codes Misfire (2532); Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed misfire and material deformation.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 5f051503cs vascular stent allegedly experienced misfire and material deformation.This information was received from one source.There were no consequences to the one patient involved.The patient was reported as a (b)(6) year old male weighing (b)(6) pounds.
 
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Brand Name
LIFESTENT 5F VASCULAR STENT SYSTEM
Common Device Name
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key9570157
Report Number9681442-2020-00001
Device Sequence Number3244530
Product Code NIP
UDI-Device Identifier00801741120664
UDI-Public(01)00801741120664
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number5F051503CS
Device Catalogue Number5F051503CS
Device Lot NumberANCW2106
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/31/2019
Initial Report FDA Received Date01/09/2020
Patient Sequence Number1
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