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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT - MT-6F-ZVL 14/120/135

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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT - MT-6F-ZVL 14/120/135 Back to Search Results
Catalog Number ZVL14120
Device Problems Positioning Failure (1158); Misfire (2532); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported positioning failure, misfire, detachment of device or device component and material deformation.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(b)(4).
 
Event Description
This report summarizes one malfunction.A review of the reported information indicates that model zvl14120 vascular sent allegedly experienced positioning failure, misfire, detachment of device or device component and material deformation.The information was received from a single source.This malfunction involved patient with no patient consequences.A (b)(6) years old female patients' weight was not provided.
 
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Brand Name
E-LUMINEXX VASCULAR STENT - MT-6F-ZVL 14/120/135
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 Key11223682
MDR Text Key228465224
Report Number9681442-2021-80005
Device Sequence Number1
Product Code NIO
UDI-Device Identifier00801741111280
UDI-Public(01)00801741111280
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 01/25/2021
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
Device Operator No Information
Device Catalogue NumberZVL14120
Device Lot NumberANDP2232
Initial Date Manufacturer Received 12/31/2020
Initial Date FDA Received01/25/2021
Type of Device Usage N
Patient Sequence Number1
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