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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 FVL06060
Device Problems Difficult or Delayed Positioning (1157); Fracture (1260); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
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.The catalog number identified has not been cleared in the us, but is similar to the endovascular stent graft products that are cleared in the us.The pro code for the endovascular stent graft products is identified.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model fvl06060 vascular stent graft allegedly experienced difficulty to deploy, a fracture, and malposition of device.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a (b)(6)-year-old male whose weight was not provided.
 
Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation identified difficult to deploy, malposition of device, and outer sheath fracture.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.The catalog number identified in section d4 has not been cleared in the us, but is similar to the endovascular stent graft products that are cleared in the us.The pro code for the endovascular stent graft products is identified in d2.H10: g4.H11: h6 (results, 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.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model fvl06060 vascular stent graft allegedly experienced difficulty to deploy, a fracture, and malposition of device.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 47-year-old male whose weight was 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 Key9188762
MDR Text Key169243840
Report Number9681442-2019-00170
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741144967
UDI-Public(01)00801741144967
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberFVL06060
Device Lot NumberANCV3742
Date Manufacturer Received12/31/2019
Patient Sequence Number1
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