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

Model Number 5010024

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

Batch history review: the manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.No other similar complaint was reported on this batch of vena cava filters.Investigation despite requests, either precise information about the incident 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 (b)(6) 2007, patient was implanted with the lp filter system.Patient had been hospitalized for problems and had the ivc filter implanted for the treatment of recurrent pulmonary embolisms.It was decided that the patient would undergo the implant to prevent further complications.Based on advice given the patient agreed to the implantation of the ivc filter.The physician conducted this procedure and deployed the filter in the patent's right groin at the l3-l4 level.The filter was positively identified on medical records and implant labels.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.The patient, on or about (b)(6) 2015 was hospitalized for chronic right side pain in the area where the ivc filter was implanted.A scan on the patient confirmed that an ivc filter was present at the l3-l4.Chronic pains in the area where the filter was implanted can be an indicator of further complications with the filter such as migration, tilt, fracture or breakage of the filter, perforation of the vena cava or other soft tissue, and other serious problems.The patient's implant, remains within the body for over nine 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 CAVA 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: 7057667
• MDR Text Key: 92864337
• Report Number: 9612452-2017-00047
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 04038653918164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010485
• 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: 11/24/2017

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
• Device Expiration Date: 01/31/2012
• Device Model Number: 5010024
• Device Catalogue Number: 5010024
• Device Lot Number: F0101263V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other