MAUDE Adverse Event Report: B .BRAUN MEDICAL SAS CONVERTIBLE VENATECH FILTER; VENA CAVA FILTER SYTEM

Catalog Number	5010028
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite requests, either precise information about the incident nor device nor x-ray pictures are available for analysis.No thorough investigation can be performed.No conclusion can be drawn.B braun (b)(4) has provided all the information currently available to us.In spite of all reasonable efforts being made to obtain further information or the device, at this time we have not met with success.
Event or Problem Description
Placement of a convertible filter in the presence of right lower-extremity deep vein thrombosis to prevent pulmonary embolism.The filter was implanted at an unknown hospital.Nineteen days later, patient was referred for the discontinuation of ivc filtration.Right internal jugular vein access was obtained, an 18-30 mm ensnare endovascular snare was advanced to the filter.The filter head was grasped with the snare and detached from the legs of the filter, resulting in a 180 degree turn such that the hook of the filter head was latched onto the opening of the sheath, with the remainder of the filter head residing outside the sheath.During the process of obtaining femoral access, the filter head dislodged from the edge of the sheath and embolized to a branch of the left lower-lobe pulmonary artery.A 9-15 mm ensnare endovascular snare was advanced from the femoral access site, and the filter head was snared and removed from the patient.The postprocedural course was unremarkable, and the patient continued to receive long-term anticoagulation for deep vein thrombosis as directed by the primary clinical team.

• Brand Name: CONVERTIBLE VENATECH FILTER
• Common Device Name: VENA CAVA FILTER SYTEM
• Manufacturer (Section D): B .BRAUN MEDICAL SAS; 204 avenue du marechal juin; boulogne billancourt, 92100 ; FR 92100
• MDR Report Key: 6352063
• Report Number: 9612452-2017-00013
• Device Sequence Number: 10770795
• Product Code: DTK
• UDI-Device Identifier: 04027478130752
• UDI-Public: 04027478130752
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K152765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2017

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: Physician
• Device Catalogue Number: 5010028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR