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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.010995
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/20/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Event: duodenum perforation.On (b)(6) 2020, the patient underwent an ivc filter implantation procedure.The patient had regularly gotten checked up other underlying diseases and underwent a ct scan.It showed perforation by the filter.The patient underwent endoscopy to check more details on (b)(6) 2021.It was observed the filter device perforated the duodenum.Patient's condition after the operation: stable.Patient's anatomy after the implantation: there is no tortuosity in the implantation lesion.
 
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Brand Name
ALN OPTIONAL VENA CAVA FILTER
Common Device Name
VENA CAVA FILTER
Manufacturer (Section D)
ALN IMPLANTS CHIRURGICAUX
589 chemin du niel
bormes les mimosas, 83230
FR  83230
MDR Report Key11752482
Report Number3007080617-2021-00002
Device Sequence Number4168508
Product Code DTK
UDI-Device Identifier03760017680004
UDI-Public3760017680004
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K163699
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberFF.010995
Device Lot Number131117
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/21/2021
Initial Report FDA Received Date04/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age40 YR
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