MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number EC500F

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Unintended Movement (3026)

Patient Problem Thrombus (2101)

Event Date 12/05/2011

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately two months post filter deployment, ct revealed occluded filter.Venography revealed that the vena cava was occluded completely from the level of renal veins, down the inferior vena cava filter which was approximately 1cm below the lowest renal veins, was occluded and there was also occlusive thrombus between the filter and renal veins.Suction aspiration of the inferior vena filter for the clot above the ivc filter was performed with large amounts of subacute clot and also chronic, white appearing clot being extracted.It was reported that prior to a thrombectomy procedure, another filter was placed proximal to the previous one.Subsequently, next day ct revealed presence of two ivc filters.Approximately five years later, x-ray abdomen (kub), 1 view revealed second bard type ivc filter at the l4-l5 level.Approximately three months later, ct revealed the second lower ivc filter extend to the level of bifurcation and confluence of ivc with common iliac veins.Therefore, the investigation is confirmed for unintended movement, migration of the filter and occlusion of the ivc filter.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and post gastric bypass.It was alleged that the filter migrated, occluded, moved 0.5cm up from the deployment site and there was thrombus above the filter.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9817136
• MDR Text Key: 182984135
• Report Number: 2020394-2020-01418
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LASIX, CALCIUM, VITAMIN C, VITAMIN D; PLAVIX, ATENOLOL, DOXYCYCLINE
• Patient Outcome(s): Other
• Patient Age: 56 YR