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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 5F061203CS
Medical Device Problem Codes Malposition of Device (2616); 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 was provided, therefore a lot history review was not performed.The sample was not returned and the investigation is inconclusive for stent foreshortening/ jumping.The definitive root cause could not be determined based upon available information.The device was labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 5f061203cs lifestent 5f vascular stent system allegedly experienced malposition of device and material deformation.This information was received from one source.This malfunction involved one patient with no consequences.The (b)(6) year old patient's gender was not provided.
 
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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 Key10722674
Report Number9681442-2020-00214
Device Sequence Number3261431
Product Code NIP
UDI-Device Identifier00801741120190
UDI-Public(01)00801741120190
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) 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number5F061203CS
Device Catalogue Number5F061203CS
Device Lot NumberANDV4504
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/22/2020
Patient Sequence Number1
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