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); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2012

Event Type  malfunction  

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 underwent successful vena cava filter placement prior to knee arthroplasty.Approximately three months later, an attempt was made to remove the filter.Preliminary abdominal imaging showed slight inferior migration and tilt of the filter since the initial placement, the cone of the filter along the lateral wall of the cava and two of the struts seen extending outside the expected caval lumen.Jugular access was gained and an inferior venacavogram demonstrated three anchors outside the expected lumen of the distal inferior vena cava (ivc).The uppermost strut was seen extending approximately 1 cm medial to the medial wall of the distal ivc.There was no extravasation seen.Several attempts were made at retrieval with a sheath and snare, but the filter could not be retrieved.Approximately 18 months post filter placement, x-ray of the lumbar spine showed the filter located at approximately the l4 level.No further information is noted regarding the patient¿s current status.(b)(4).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 after the patient was diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with or before an orthopedic procedure.At some time post filter deployment, it was alleged that the filter tilted and embedded in the vena cava wall and was unable to be retrieved during a percutaneous removal procedure.The current patient status is unknown.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient underwent successful vena cava filter placement prior to knee arthroplasty.Approximately three months later, an attempt was made to remove the filter.Preliminary abdominal imaging showed slight inferior migration and tilt of the filter since the initial placement, the cone of the filter along the lateral wall of the cava and two of the struts seen extending outside the expected caval lumen.Jugular access was gained and an inferior venacavogram demonstrated three anchors outside the expected lumen of the distal inferior vena cava (ivc).The uppermost strut was seen extending approximately 1 cm medial to the medial wall of the distal ivc.There was no extravasation seen.Several attempts were made at retrieval with a sheath and snare, but the filter could not be retrieved.Approximately 18 months post filter placement, x-ray of the lumbar spine showed the filter located at approximately the l4 level.No further information is noted regarding the patient¿s current status.Investigation summary: the device was not returned.Images were not provided for review.Medical records were provided and reviewed.The filter was successfully deployed in the infrarenal position.Three months post deployment, an attempt was made to remove the ivc filter.Preliminary abdominal imaging showed slight inferior migration and tilt of the filter since the initial placement.The cone along the lateral wall of the cava and two of the struts seen extending outside the expected ivc lumen.An ivc cavogram demonstrated three anchors outside the expected lumen of the distal inferior vena cava with at least one uppermost embedded anchor seen 1 cm medial to the medial wall of distal ivc and no extravasation.The hook was snared but was unable to collapse the filter.Several additional attempts were made at retrieval with sheath and snare, but the filter could not be retrieved.Therefore, based on the provided medical records the investigation can be confirmed for a tilted filter, perforation of the ivc, migration, 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.Migration of filters to the heart or lungs has been reported.There have also been reports of caudal migration of the filter.Migration may be caused by placement in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.Perforation or other acute or chronic damage of the ivc wall.Filter malposition.Filter tilt.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.All of the above complications may be associated with serious adverse events such as medical intervention and/or death.(b)(4).

Event Description

It was reported through the litigation process that a vena cava filter was placed after the patient was diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with or before an orthopedic procedure.At some time post filter deployment, it was alleged that the filter tilted and embedded in the vena cava wall and was unable to be retrieved during a percutaneous removal procedure.The current patient status 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7153474
• MDR Text Key: 96026170
• Report Number: 2020394-2017-01837
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: EC500F
• Device Lot Number: GFVJ0525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• 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 Age: 58 YR