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U.S. Department of Health and Human Services

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

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ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VENA CAVA FILTER VENA CAVE FILTER Back to Search Results
Model Number FJ.120096
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2020
Event Type  Injury  
Event Description
In (b)(6) 2020, the patient underwent an ivc filter implantation procedure for dvt. On (b)(6) 2020, endoscopic images revealed perforation in the duodenum. Patient asymptomatic. On (b)(6) 2020, the physician removed the filter with the filter extraction kit. A check angiography revealed the extravasation occurred where the filter perforated. The physician thinks that it is not serious.
 
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Brand NameALN OPTIONAL VENA CAVA FILTER
Type of DeviceVENA CAVE 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 Key10618675
MDR Text Key209558531
Report Number3007080617-2020-00003
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeJA
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 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFJ.120096
Device Lot Number121217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/02/2020 Patient Sequence Number: 1
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