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); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) 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 after four years and five months post filter deployment, computed tomography revealed the apex of the inferior vena cava filter was at the level of the renal veins.The inferior vena cava apex was slightly tilted to the left and slightly anterior.The struts of the inferior vena cava filter extend beyond the wall the inferior vena cava, particularly on the right side.Approximately seven months later, patient scheduled for filter retrieval.An inferior vena cavogram was performed it revealed infrarenal inferior vena cava filter was noted without severe tilt.Attempts were made to retrieve the filter using sheath and snare but were unsuccessful.Balloon catheter was also used.But, the balloon had no effect on the position or location of the filter apex.Balloon was deflated and advanced further caudally and re inflated in the inferior vena cava below the filter.It was carefully pulled back up, but it passes through the filter without any significant deflection of struts or the filter apex.The balloon snare was reinserted and opened and closed multiple times at the filter apex thereby releasing fibrous tissue that was trapping the filter apex.Thereafter the sheath could be advanced around the entire filter apex.The filter was then removed and inspection of the filter reveals 6 long struts and only 5 short struts indicating the presence of a missing strut in the body.Still spot film digital images of the thorax show the missing strut projecting over the base of the heart left of midline.Cone beam computed tomography (ct) images show the strut along the posterior surface of the base of the heart.A computed tomography (ct) thorax without contrast was performed it revealed there was a linear metallic object within a small sub segmental branch in the posterior medial left lower lobe.In the interval, it has passed through the heart and has embolized into this tiny sub segmental left lower lobe pulmonary artery branch.Therefore, the investigation is confirmed for perforation of the ivc, retrieval difficulties an filter limb detachment.However, the investigation is inconclusive for filter tilt.Based on the provided medical records, there is no objective evidence to confirm for filter tilt as it states ¿the inferior vena cava apex was slightly tilted to the left and slightly anterior and inferior vena cava filter was noted without severe 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.

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 and retroperitoneal hematoma status post left knee replacement.At some time post filter deployment, it was alleged that the filter tilted and struts perforated the vena cava wall and to the mesentery.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.

• 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: 10127032
• MDR Text Key: 194312010
• Report Number: 2020394-2020-03656
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• 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
• Date Manufacturer Received: 05/18/2020
• 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: ASPIRIN, CLONAZEPAM, ATACAND, GABAPENTIN; HYDROCHLOROTHIAZIDE, OMEPRAZOLE, SIMVASTATIN; LAMOTRIGINE, SYNTHROID, METOPROLOL, FIORICET; VALIUM, COUMADIN, PLAQUENIL, VERAPAMIL; VITAMIN D, TIZANIDINE AND CANDESARTAN
• Patient Outcome(s): Other
• Patient Age: 68 YR