MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS VENATECH LP; VENA CAVE FILTER SYSTEM

Device Problem Use of Device Problem (1670)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

Batch history review is not possible because either the product reference nor the batch number of the involved device is known.Despite requests, either precise information about the device nor x-ray pictures are available for analysis.Consequently no thorough investigation can be performed.No link between the filter and the reported complaint can be established.No conclusion can be drawn.B braun medical (b)(4) has provided all the information currently available.In spite of all reasonable efforts being made to obtain further information, at this time we have not met with success.

Event Description

"on or about on (b)(6) 2003, patient was implanted with the venatech vena cava filter.Patient had been hospitalized, and upon information and belief, was implanted the filter for pre-surgical purposes of prevent further dvts.The filter system that was implanted was positively identified on patient's medical records.The surgery was ordered by a dr.(b)(6).Upon information and belief, the filter was implanted and utilized in accordance with braun's specific instructions, guidelines, and directives.The patient has never considered for revision or removal of the device by any medical professionals, nor was the patient recommended to consider removal upon discharge.On or about (b)(6) 2017, patient received a scan on abdomen region after complaints of lower extremity swelling.The scan confirmed patient's ivc filter was within the affect region and mild calcification within that area as well.The patient's implant, remains within the body for over fourteen years, which constitutes a long-term implant and made the patient dramatically more susceptible to the threat of imminent threat of death, migration, thrombosis, blockage or other life-threatening side effects.".

• Brand Name: VENATECH LP
• Type of Device: VENA CAVE FILTER SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 204 avenue du marechal juin; boulogne, 92100 ; FR 92100
• Manufacturer (Section G): B.BRAUN MEDICAL SAS; avenue des temps modernes; chasseneuil, 86361 ; FR 86361
• Manufacturer Contact: catherine boismenu ; 30, avenue des temps modernes; chasseneuil du poitou 86360 ; FR 86360
• MDR Report Key: 7057671
• MDR Text Key: 92858077
• Report Number: 9612452-2017-00046
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other