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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 FVL06080
Device Problems Difficult to Remove (1528); Retraction Problem (1536); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The devices for each of the two malfunctions have not been returned for evaluation; therefore, the investigation is inconclusive for difficulty to remove, a retraction problem, and a guidewire related issue as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
 
Event Description
This report summarizes two malfunctions.A review of the reported information indicated that model fvl06080 vascular stent graft allegedly experienced difficulty to remove, a retraction problem, and a guidewire related issue.This information was received from various sources.Of the two malfunctions, both involved patients with no reported consequences.The age, weight, and sex were not provided for either of the patients.
 
Event Description
This report summarizes two malfunctions.A review of the reported information indicated that model fvl06080 vascular stent graft allegedly experienced difficulty to remove, a retraction problem, and a guidewire related issue.This information was received from various sources.Of the two malfunctions, both involved patients with no reported consequences.The age, weight, and sex were not provided for either of the patients.
 
Manufacturer Narrative
H10: the devices for each of the two malfunctions have not been returned for evaluation; therefore, the investigation is inconclusive for difficulty to remove, a retraction problem, and a guidewire related issue as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: after further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is 9681442.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.
 
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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 Key8794591
MDR Text Key151175217
Report Number2020394-2019-01525
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberFVL06080
Device Lot NumberANBX1510
Date Manufacturer Received09/30/2019
Patient Sequence Number1
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