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

Catalog Number MD800J

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, four years and eight months of post-deployment computed tomography of abdomen and pelvis was revealed an inferior vena cava filter was in the infra renal inferior vena cava.There are two tines that extend posteriorly outside the lumen adjacent to the vertebral body and an additional tine which extends medially to abut the lateral wall of the aorta.The infra renal inferior vena cava was small in caliber but no definite intraluminal thrombus was identified within the inferior vena cava, common, internal and external iliac veins or the included.Around one and two months later, the patient experienced abdominal pain, radiates to the back associated with her inferior vena cava filter, computed tomography of abdomen and pelvis without contrast was performed for fragmented inferior vena cava filter which demonstrated an inferior vena cava filter with two extraluminal tines that project posteriorly into the vertebral body and one tine that projects near the aorta and there was re-demonstration of an infra renal inferior vena cava filter with mild caval penetration of the filter limbs, overall unchanged.There are small intra-abdominal/pelvic and abdominal wall venous collaterals, likely reflecting underlying chronic central venous stenosis.After three days, inferior vena cavogram was performed for removal of inferior vena cava filter, through the right internal jugular vein approach, which showed a guidewire was passed down the inferior vena cava through the right atrium into the inferior vena cava.Wire exchanged to a stiff wire was carried out and a 12 french sheath was then carefully placed over the wire to just above the level of the nose cone of the inferior vena cava filter.An 8 french sheath was then used inside of the 12 french sheath and an ensnare three snare device was used to capture the hook of the needle.This was done in a team-like fashion with both surgeons controlling the various devices to enable successful snare of the filter.The filter was engaged and then brought to the sheath, the sheath was then pushed down over the filter and the filter released and entirely came into the sheath and was pulled back well into the sheath itself.Completion venogram was performed which showed some narrowing of the inferior vena cava, but good flow in this area and no obvious deep vein thrombosis and no evidence of hemorrhage outside of the inferior vena cava.The patient tolerated the procedure well and was taken to the recovery room in satisfactory position.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and filter limb detachment.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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism while on anticoagulants.At some time, post filter deployment, it was alleged that the filter struts perforated, detached and the patient reportedly experienced pain.The device was removed percutaneously.The current status of the patient is unknown.

• Brand Name: MERIDIAN FILTER SYSTEM - JUGULAR
• 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: 12629935
• MDR Text Key: 276350470
• Report Number: 2020394-2021-80762
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102511
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• 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: XARELTO, BENADRYL AND METHYLPREDNISOLONE
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 113