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

Catalog Number UNK MERIDIAN

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Thrombus (2101)

Event Date 04/15/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record will not be performed.The device has not been returned to the manufacturer for evaluation; however, medical record and images are provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported through the litigation process that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided.At some time post filter deployment, it was alleged that the filter tilted and struts perforated into pericaval/mesenteric.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly diagnosed with pulmonary embolism post implant; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: 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.Post-deployment duplex venous ultrasound right lower extremity showed positive for extensive acute deep venous thrombosis extended from the proximal right common femoral vein through profunda femoral vein, femoral vein, popliteal vein, posterior tibial vein, gastrocnemius vein and saphenofemoral junction.Also, a computed tomography angiography (cta) abdomen and pelvis with and without contrast showed that an inferior vena cava filter was noted.The tip was at the level of the renal veins.On the venous and arterial phase images, there was a definite thrombus within the inferior vena cava at the level of the filter and slightly cephalad to the level of the filter.The thrombus extended 2.7 cm cephalad to the filter.The remainder of the intrahepatic inferior vena cava was patent without thrombus.Around three days later, the patient underwent thrombolysis with an ekos catheter.Eventually, two weeks and two days later, the patient was diagnosed with extensive thrombus that extended from the popliteal vein on the right side through the femoral vein, common femoral vein, some of the profunda femoral vein, external iliac vein, common iliac vein as well as the inferior vena cava into the filter and possibly extended beyond the filter somewhat.Subsequently, five months and fifteen days later, contiguous axial projection images using computed tomography (ct) abdomen was revealed that a bard meridian infra-renal inferior vena cava filter type was present below the renal veins.Some of the filter struts had penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.The filter was tilted to the left with its proximal cone lay on the wall of the inferior vena cava, possibly embedded in it.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.Additionally, it can be confirmed that the patient experienced thrombus above the filter post-deployment.However, the relationship to the filter is unknown.However, the investigation is inconclusive for pe post-deployment.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.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 deployed successfully, the reason for the filter deployment was not provided.At some time post filter deployment, it was alleged that the filter tilted and struts perforated into pericaval/mesenteric.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly diagnosed with pulmonary embolism post implant; however, the current status of the patient is unknown.

• Brand Name: MERIDIAN FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10716702
• MDR Text Key: 212452224
• Report Number: 2020394-2020-06002
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK MERIDIAN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 50 YR