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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
Catalog Number 5F070601C
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided for the reported malfunction, therefore, a lot history review is was performed.The device was not returned evaluation.The investigation is inconclusive for alleged malfunction.Based on the available information, the definitive root cause for this event could not be determined.The device is labeled for single use.The catalog number has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicates that model 5f070601c vascular stent allegedly experienced material deformation.The information was received from a single source.The malfunction involved a patient with no known impact to the patient.The male patients' age and weight were not provided.
 
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Brand Name
LIFESTENT 5F VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM   76227
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10722734
MDR Text Key213214053
Report Number9681442-2020-00218
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120381
UDI-Public(01)00801741120381
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5F070601C
Device Lot NumberANCW1312
Date Manufacturer Received09/30/2020
Type of Device Usage N
Patient Sequence Number1
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