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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT SYSTEM Back to Search Results
Catalog Number EX071001JL
Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model ex071001jl vascular stent allegedly experienced device-device incompatibility, positioning problem, and advancement issues.This information was received from one source.This event involved one patient with no patient consequences.Age, weight, and gender were not provided.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model ex071001jl vascular stent allegedly experienced device-device incompatibility, positioning problem, and advancement issues.This information was received from one source.This event involved one patient with no patient consequences.Age, weight, and gender were not provided.
 
Manufacturer Narrative
H10: the lot number for the device was provided; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4, h6(device: 2524).H11: g1, h6(method, conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
LIFESTENT SOLO VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key9941383
MDR Text Key187391382
Report Number9681442-2020-00089
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741110276
UDI-Public(01)00801741110276
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/18/2020
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
Device Operator No Information
Device Catalogue NumberEX071001JL
Device Lot NumberANCN3406
Initial Date Manufacturer Received 03/31/2020
Initial Date FDA Received04/08/2020
Supplement Dates Manufacturer Received06/18/2020
Supplement Dates FDA Received06/18/2020
Patient Sequence Number1
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