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

Catalog Number MD800F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problem Extravasation (1842)

Event Date 06/20/2014

Event Type  Injury  

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 inferior vena cava.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.

Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately six months later post filter deployment, a computed tomography of abdomen and pelvis was performed for evaluation of inferior vena cava filter.The study showed an inferior vena cava filter posteriorly displaced with the filter tip abutted or embedded in the posterior wall of the inferior vena cava and the filter appeared to be meridian type.On the same day, the bard meridian inferior vena cava filter was attempted for removal.The right internal jugular vein was accessed and a 5-french coaxial dilator along with the 6-french long sheath was placed.Then a 6-french straight multi-side hole catheter was advanced through the patient¿s existing inferior vena cava filter.Then a 10-french delivery system was advanced above the level of the inferior vena cava.Multiple attempts at a 20mm gooseneck snare were attempted to remove the patient¿s inferior vena cava filter.Then a reversed curve catheter was reformed in the patient¿s iliac veins and a guidewire was advanced and snared from above the level of the filter but, the meridian inferior vena cava filter could not be removed.An inferior vena cavagram was performed which demonstrated the filter hook to be embedded within the inferior vena cava wall.At this time, it was felt that the risk versus benefit at attempting more aggressive removal techniques were not warranted.As the patient had no contraindication to inferior vena cava filter removal.Finally, the removal attempt was unsuccessful, and it was concluded that the filter hook was embedded within the inferior vena cava wall and the risk for removing this filter was not felt to be warranted at the time.After four years and ten months, previously performed computed tomographic images, were reviewed and the study demonstrated the filter was at the l1-l2 to l3 interspace and it was found that the migration was unlikely based on the imaging study.The study also showed that there was a posterior tilt of 11-degrees demonstrated in the sagittal plane was identified and this showed negative for tilt.Also, a grade 3 perforation was noted with a ventral strut extended 5mm outside the cava wall abutted the duodenum.At the same time, the images during the retrieval attempt were also reviewed and the study showed that the filter was at the l1 to l2-l3 interspace.There was no significant tilt noted and there was probable mild left extravasation indicated.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava and retrieval difficulties.However, the investigation is unconfirmed for the alleged filter tilt as medical records states "there was a posterior tilt of 11-degrees demonstrated in the sagittal plane was identified and this showed negative for tilt".Based on 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.

• Brand Name: MERIDIAN 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: 13504543
• MDR Text Key: 285462600
• Report Number: 2020394-2022-90080
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112497
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ATENONOL, LISINOPRIL, DOCUSATE, MORPHINE; FENTANYL, DILAUDID, PERCOCET, ASPIRIN; RANITIDINE AND COUMADIN; ZOFRAN, WARFARIN, OXYCODONE
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White