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

Catalog Number EC500J

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2014).

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, struts detached and perforated.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The detached strut retained in l4 vertebral body.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Images and medical records were provided and reviewed.Upon image review, axial and sagital ct scan images show an inferior vena cava filter with fractured leg(s) and legs perforating the inferior vena cava.One of the legs appears imbedded in a nearby vertebral body.Upon medical records review, approximately nine months later, the patient experienced right sided abdominal pain, computed tomography of pelvis without contrast was performed which revealed there was an inferior vena caval filter, below the right renal vein.After three years and three months, computed tomography of chest pulmonary embolism with contrast was performed which showed positive for small pulmonary arterial emboli are seen in segmental branches of the right lower lobe.After eleven months, computed tomography of abdomen and pelvis with contrast was performed for acute abdominal pain and inferior vena caval thrombosis which showed the inferior vena cava was narrow and probably occluded just above the inferior vena caval filter visualized at the l4 level.Large subcutaneous anterior abdominal wall varices provide collateral circulation from the right and left external iliac veins due to the inferior vena caval obstruction.Chronic occlusion of infrarenal inferior vena cava with an umbrella filter in place, coming by venous collateral circulation from the right and left iliac veins through subcutaneous varicosities of the anterior abdominal wall.The filter was tilted to the right with its cone lying on the right lateral wall of the inferior vena cava possibly embedded within it.The arms and legs of the filter have penetrated through the wall of the inferior vena cava into the pericaval mesenteric fat.After one year and six-month, evaluation of inferior vena cava filter was performed which showed bilateral ideal caval occlusion with a fracture filter fragment embedded within the l4 vertebral body.On the same day, inferior vena cava filter retrieval was performed which showed a cook retrieval sheath/snare was advanced down into the inferior vena cava and abruptly had resistance approximately two centimeters above the inferior vena cava filter hook.Multiple wires and catheters were used to advance through the chronic occlusion from above.Real-time ultrasound guided micropuncture access was also attempted via both the right and left common femoral veins into the iliac venous occlusions, via the jugular access, 10 mm angioplasty was performed from just above the inferior vena cava filter through the right iliac occlusion.Attempts were then made using multiple snares as well as graspers to retrieve the filter from the filter hook which appeared firmly embedded in the caval wall.The left femoral access was angioplastied throughout with 10 mm angioplasty balloon as well as angioplasty through the right femoral access up through the filter.Multiple additional attempts trying to snare or grasp of the filter hook without success.Given large radiation dose and fluoroscopic time, decision was made to stent the iliac veins up to the inferior vena cava filter to maintain patency and relieve patient's symptoms.Flow was restored without complication.Initial cavogram from the jugular access with the catheter positioned in the right common iliac vein demonstrates diffuse chronic thrombotic occlusive attenuation throughout the inferior filter extending above the filter.Balloon angioplasty was performed from approximately one vertebral body above the inferior vena cava filter through the bilateral common iliac and external iliac veins as described with restoration of flow followed by stenting of the bilateral common femoral, external iliac and iliac veins as described.The inferior vena cava filter sits at the iliac confluence.Bilateral iliofemoral chronic venous occlusion extending through the lower inferior vena cava and above the inferior vena cava filter status post successful recanalization with angioplasty and stenting as described.Unsuccessful multiple attempts for removal of the inferior vena cava filter.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava, filter migration, filter limb detachment, filter occlusion, filter tilt and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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.H10: d4(expiry date: 01/2014), g3, h6(device, method).H11: h6(result, conclusion).H11:section a through f - the information provided by bd 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 bd.

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, struts detached and perforated.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The detached strut retained in l4 vertebral body.The current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12273184
• MDR Text Key: 264925231
• Report Number: 2020394-2021-80685
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500J
• Device Lot Number: GFUL1919
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACTRIM, CLONIDINE, VICODIN AND NAPROSYN; BACTRIM, CLONIDINE, VICODIN AND NAPROSYN; BENADRYL, SODIUM CHLORIDE, PHENERGAN, LOVENOX; BENADRYL, SODIUM CHLORIDE, PHENERGAN, LOVENOX; CLINDAMYCIN, OXYCODONE-ACETAMINOPHEN, COUMADIN; CLINDAMYCIN, OXYCODONE-ACETAMINOPHEN, COUMADIN; GABAPENTIN, LEVOFLOXACIN, HYDROMORPHONE; GABAPENTIN, LEVOFLOXACIN, HYDROMORPHONE; ONDANSETRON, IBUPROFEN, LISINOPRIL, IOPAMIDOL; ONDANSETRON, IBUPROFEN, LISINOPRIL, IOPAMIDOL; OXYCODONE, TRAMADOL, APIXABAN, TYLENOL; OXYCODONE, TRAMADOL, APIXABAN, TYLENOL; BACTRIM, CLONIDINE, VICODIN AND NAPROSYN; BENADRYL, SODIUM CHLORIDE, PHENERGAN, LOVENOX; CLINDAMYCIN, OXYCODONE-ACETAMINOPHEN, COUMADIN; GABAPENTIN, LEVOFLOXACIN, HYDROMORPHONE; ONDANSETRON, IBUPROFEN, LISINOPRIL, IOPAMIDOL; OXYCODONE, TRAMADOL, APIXABAN, TYLENOL
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 44 YR
• Patient Weight: 135