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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVL14100
Device Problems Positioning Failure (1158); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.The company is still investigating the issue at this time.The catalog number identified has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicates that model fvl14100 vascular stent graft experienced a positioning failure and misfire.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The male patient age and weight were not provided.
 
Manufacturer Narrative
The initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is 03/31/2020.The lot number was provided; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.The company is still investigating the issue at this time.The catalog number identified in section d4 has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified in d2.The device is labeled for single use.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.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicates that model fvl14100 vascular stent graft experienced a positioning failure and misfire.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The male patient age and weight were not provided.
 
Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was performed.The sample was returned and the investigation confirmed for partial deployment.A definite root cause for the reported event could not be determined.The device was labeled for single use.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.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicates that model fvl14100 vascular stent graft experienced a positioning failure and misfire.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The male patient age and weight were not provided.
 
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Brand Name
FLUENCY PLUS VASCULAR STENT GRAFT
Type of Device
VASCULAR STENT GRAFT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key9955550
MDR Text Key187522351
Report Number9681442-2020-00098
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145360
UDI-Public(01)00801741145360
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 06/26/2020
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 NumberFVL14100
Device Lot NumberANBY1160
Initial Date Manufacturer Received 04/01/2020
Initial Date FDA Received04/13/2020
Supplement Dates Manufacturer Received04/21/2020
06/26/2020
Supplement Dates FDA Received04/21/2020
06/26/2020
Patient Sequence Number1
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