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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 FVL08040
Device Problems Fracture (1260); Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/18/2022
Event Type  Injury  
Event Description
It was reported that approximately two years and ten months post stent placement procedure, the tip of the stent was allegedly fractured and the fractured part was migrated to heart.The current status of the patient is unknown.
 
Manufacturer Narrative
The catalog number identified in section 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 pro code and 510k number for the fluency plus endovascular stent graft products are identified.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).Device not returned.
 
Manufacturer Narrative
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 pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: a sample was not available for evaluation since the covered stent is still implanted in the patient but photos were provided which show the covered stent; a fracture or migration could not be identified which leads to inconclusive results.The stent was used for a tips procedure which is off label and which is considered a significant factor; high deployment force was experienced.Based on the available information and evaluation of the provided photos, the investigation is closed with inconclusive results for stent fracture and migration.A definite root cause of the reported incident could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state that the product is indicated 'for use in the iliac and femoral arteries'.The instructions for use closely describes holding and handling of the device during the procedure.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.H3 other text : device not returned.
 
Event Description
It was reported that approximately two years and ten months post stent placement procedure, the tip of the stent was allegedly fractured and the fractured part was migrated to heart.The current status of the patient is unknown.
 
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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
wachhausstr. 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM   76227
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key15527021
MDR Text Key301013970
Report Number9681442-2022-00294
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145094
UDI-Public(01)00801741145094
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFVL08040
Device Lot NumberANDN2011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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