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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VENA CAVA FILTER

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ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VENA CAVA FILTER Back to Search Results
Model Number FF.HOOK
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2020
Event Type  Injury  
Event Description
Implantation by right femoral approach following floating venous thrombus in femoral vein in left limb. Incomplete opening of the filter leading to migration to the left pulmonary artery. Filter removed from the pulmonary artery with a lasso but anchored strongly in right iliac vein in a transverse position. Decision to leave the filter in that position after multiple attempts of extraction using a snare and the filter extraction kit both via femoral and jugular routes. Successful implantation of a second filter by jugular approach.
 
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Brand NameALN OPTIONAL VENA CAVA FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
ALN IMPLANTS CHIRURGICAUX
589 chemin du niel
bormes les mimosas, 83230
FR 83230
Manufacturer Contact
severine joly
589 chemin du niel
bormes les mimosas, 83230
FR   83230
MDR Report Key10975548
MDR Text Key220427253
Report Number3007080617-2020-00004
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K163699
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFF.HOOK
Device Lot Number040119
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/09/2020 Patient Sequence Number: 1
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