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

Model Number 31335

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2016

Event Type  Injury  

Event 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: LP VENATECH FILTER
• Type of Device: VENATECH FILTER
• Manufacturer (Section D): B. BRAUN MEDICAL SAS; 26 rue armengaud; saint-cloud 92210 ; FR 92210
• MDR Report Key: 10132656
• MDR Text Key: 198140065
• Report Number: 3006332832-2020-00006
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 06/05/2020

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
• Device Operator: No Information
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: K055341V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2020
• Distributor Facility Aware Date: 05/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention