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); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem Pulmonary Embolism (1498)

Event Date 04/12/2016

Event Type  Injury  

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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately four years post filter deployment, patient presented with chest pain.Subsequent ct revealed that there was thrombus in the sub segmental branches of the left lower lobe, right lower lobe, suggesting acute bilateral pulmonary embolism.Approximately two and half years later, ct revealed ivc filter appeared to be slightly upwardly positioned and the tip appeared to be at the level of left renal vein.There was slight tilting of the filter noted as well.One of the filter legs appear to be outside the vena cava with no evidence of localized hematoma.Therefore, the investigation is inconclusive for filter migration, filter limb detachment, perforation of the ivc and filter tilt.Based on the provided medical records, there is no clear evidence to confirm for perforation of the ivc as it reported that, ¿one of the filter legs appear to be outside the vena cava¿.Based on the provided medical records, there is no clear evidence to confirm for filter tilt as it reported that, ¿there was slight tilting of the filter noted as well.¿ additionally, it can be confirmed that the patient experienced pe 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.(expiry date: 06/2014), (b)(4).

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 detached, migrated to the heart, tilted and embedded in the wall of ivc.The device has not been removed and there were no reported attempts made to retrieve the filter.It was further reported that one of the filter struts appears to be outside the inferior vena cava.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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.Investigation summary:the device was not returned for evaluation.Medical records were provided and reviewed.Approximately four years post filter deployment, patient presented with chest pain and acute bilateral pulmonary embolism.Subsequent ct revealed that there was thrombus in the sub segmental branches of the left lower lobe, right lower lobe, suggesting acute bilateral pulmonary embolism.Approximately two and half years later, ct revealed inferior vena cava (ivc) filter appeared to be slightly upwardly positioned and the tip appeared to be at the level of left renal vein.There was slight tilting of the filter noted as well.One of the filter legs appear to be outside the vena cava with no evidence of localized hematoma.Eventually three months later, filter retrieval was scheduled.Subsequent inferior vena cavogram revealed, inferior vena cava filter was tilted, and apex of the filter was near the left renal vein origin.Multiple attempts were then made to snare the hook with help of straight, angled and trilobed snare but filter was embedded in the wall.Multiple attempts were made unsuccessfully.Therefore, the investigation is confirmed for the filter tilt and retrieval difficulties.However, the investigation is inconclusive for filter migration, filter limb detachment and perforation of the ivc.Based on the provided medical records, there is no clear evidence to confirm for perforation of the ivc as it reported that, ¿one of the filter legs appear to be outside the vena cava¿.Additionally, it can be confirmed that the patient experienced pulmonary embolism (pe) post deployment.However, the relationship to the filter is unknown.Per medical records, multiple attempts were made to engage the hook of the filter using straight, angled and trilobed snare but were unsuccessful due to filter tilt and embedment.This could have contributed to the retrieval difficulties.However, 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.H10: b7,d11,d4(expiry date: 06/2014),.

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, detached, and migrated to the heart.The device has not been removed and there were no reported attempts made to retrieve the filter.It was further reported that one of the filter struts appears to be outside the inferior vena cava.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
• MDR Report Key: 9449367
• MDR Text Key: 170214949
• Report Number: 2020394-2019-05443
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• 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: GFVF0180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL, POTASSIUM SUPPLEMENTS; COLCHICINE, GABAPENTIN, METOPROLOL SUCCINATE; COLCHICINE, GABAPENTIN, METOPROLOL SUCCINATE; IBUPROFEN, CLONAZEPAM, TRAZODONE, OMEPRAZOLE; IBUPROFEN, CLONAZEPAM, TRAZODONE, OMEPRAZOLE; LOVENOX, COUMADIN, XARELTO, CETIRIZINE; LOVENOX, COUMADIN, XARELTO, CETIRIZINE; MORPHINE SULFATE, FLEXERIL, TRAZODONE; MORPHINE SULFATE, FLEXERIL, TRAZODONE; COLCHICINE, GABAPENTIN, METOPROLOL SUCCINATE; IBUPROFEN, CLONAZEPAM, TRAZODONE, OMEPRAZOLE; LOVENOX, COUMADIN, XARELTO, CETIRIZINE; MORPHINE SULFATE, FLEXERIL, TRAZODONE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 85