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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
Lot Number ANDW1392
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified in has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The product classification code for the fluency plus endovascular stent graft product is identified.The lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model fvl08060 vascular stent graft allegedly experienced positioning problem.This information was received from one source.This malfunction involved one patient with no consequences.The weight of the (b)(6) year old male was not provided.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model fvl08060 vascular stent graft allegedly experienced positioning problem.This information was received from one source.This malfunction involved one patient with no consequences.The weight of the 42 year old male was not provided.
 
Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation is inconclusive as the reported failure could not be found.The device is labeled for single use.Based on the information available a definite root cause of the reported event could not be determined.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The product classification code for the fluency plus endovascular stent graft product is identified in d2.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
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 Key9957795
MDR Text Key187728799
Report Number9681442-2020-00118
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145100
UDI-Public(01)00801741145100
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/24/2020
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 Lot NumberANDW1392
Initial Date Manufacturer Received 03/31/2020
Initial Date FDA Received04/14/2020
Supplement Dates Manufacturer Received06/19/2020
Supplement Dates FDA Received06/24/2020
Patient Sequence Number1
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