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

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

No medical images have been made available to the manufacturer.Medical records were provided and reviewed.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient with bilateral pulmonary emboli and deep vein thrombosis underwent vena cava filter placement via femoral access.Approximately five years post filter placement, the patient presented for device removal procedure related to progressive lower extremity edema and iliocaval thrombosis related to the filter.Access gained via greater saphenous veins with wire advanced to the common femoral veins.Venography showed occlusion of the iliac veins at the level of the external iliac veins, with multiple retroperitoneal venous collaterals reconstituting the inferior vena cava (ivc) cranial to the level of the filter.With wires placed, balloon angioplasty was carried out to the level of the filter apex.Jugular access was then obtained and the filter was noted to be tilted rightward with a filter strut displaced cranially.Utilizing a snare device, unsuccessful attempts were made to capture the filter.Utilizing rigid forceps, the filter apex was dissected until the hook was freed.The filter was captured with a snare device and removed from the patient.Stents were then deployed across the occluded iliocaval segments.Completion venography demonstrated brisk flow through the recanalized iliac and caudal inferior vena caval segments.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

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.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the ivc.It was further alleged that a filter strut was pointing in an upward direction.The filter was removed percutaneously.Patient status was not provided.

Manufacturer Narrative

The lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.The patient with bilateral pulmonary emboli and deep vein thrombosis underwent vena cava filter placement via femoral access.Approximately five years post filter placement, the patient presented for device removal procedure related to progressive lower extremity edema and iliocaval thrombosis related to the filter.Access gained via greater saphenous veins with wire advanced to the common femoral veins.Venography showed occlusion of the iliac veins at the level of the external iliac veins, with multiple retroperitoneal venous collaterals reconstituting the inferior vena cava (ivc) cranial to the level of the filter.With wires placed, balloon angioplasty was carried out to the level of the filter apex.Jugular access was then obtained and the filter was noted to be tilted rightward with a filter strut displaced cranially.Utilizing a snare device, unsuccessful attempts were made to capture the filter.Utilizing rigid forceps, the filter apex was dissected until the hook was freed.The filter was captured with a snare device and removed from the patient.Stents were then deployed across the occluded iliocaval segments.Completion venography demonstrated brisk flow through the recanalized iliac and caudal inferior vena caval segments.Investigation summary: the device was not returned for evaluation and images were not provided for review.Approximately five years and two months post filter deployment, during a filter retrieval procedure, the filter was noted to be tilted rightward with a filter strut displaced cranially.Utilizing a snare device, unsuccessful attempts were made to capture the filter.Utilizing rigid forceps, the presumed cap about the filter apex was dissected until the hook was freed.The neck was then captured and withdrawn partially into the sheath.A snare device was advanced through the sheath and utilized to capture the filter within the sheath.Therefore, based on the provided medical records, the investigation is confirmed for a tilted filter, material deformation, and difficulties removing the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Filter tilt; filter malposition.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.

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.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the ivc.It was further alleged that a filter strut was pointing in an upward direction.The filter was removed percutaneously.Patient status was not provided.

• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7151850
• MDR Text Key: 95953752
• Report Number: 2020394-2017-01826
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: EC500F
• Device Lot Number: GFUA4105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 106