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

Model Number	31335
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 conclusion can be drawn.This type of incident is known complication of the vena cava filter.Compared to the literature, the complaint rate for this type of incident with venatech lp is low and satisfactory.The benefits overweight the risks.No corrective action is currently envisaged.
Event or Problem Description
Filter was implanted in patient (b)(6) 2011 and migrated into the heart.The patient had surgery to remove the filter.On (b)(6) 2016 patient underwent an echocardiogram of the chest which demonstrated that the filter had migrated in its entirety to the heart.On (b)(6) 2016 patient underwent an x-ray of the chest that confirmed the entire filter had migrated into the right atrium.On (b)(6) 2016 the patient underwent consultation with physicians who stated the filter is in the right atrium with the head oriented toward the ivc and the prongs facing toward the svc in disarray thus making percutaneous removal impossible.Patient underwent open sternotomy to remove the filter.During the removal the filter was in the right atrium with the apex in the coronary sinus and two struts of the filter were penetrating the anterior and septal tricuspid valve leaflets, requiring repair of the tricuspid valve.

• Brand Name: VENATECH LP
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 10174210
• Report Number: 9612452-2020-00021
• Device Sequence Number: 3611386
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 04038653918164
• Combination Product (Y/N): N
• PMA/510(K) Number: K010485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: K055341V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/19/2020
• 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: Hospitalization; Required Intervention