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); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately seven years and four months post deployment, through the right internal jugular vein approach, the filter was removed.An indication was provided which mentioned that the patient was referred for filter removal after presented with pain.Also, the filter was tilted, with penetrated limbs and tip embedment.During the removal procedure, multiple magnification spot images demonstrated a fractured and dislodged limb.The right internal jugular vein was accessed, and a 5-french sheath was placed.Then a vena cavography was performed which demonstrated a tip embedded filter with completely intraluminal fractured limb.Also, the filter tip was embedded and partially extraluminal.A 16-french check-flo performer sheath was advanced into the inferior vena cava at the level of the filter.Then lymol endobronchial forceps were introduced through the sheath and used to gradually dissect the filter tip from the wall of the inferior vena cava.The tip of the filter, once dissected free, was grasped with the forceps.Then with simultaneous retraction of the forceps and advancement of the sheath, the filter was removed.The tip of the fractured limb was grasped with the help of the forceps and the fragment was removed in its entirety.Post removal study showed successful complex filter retrieval using endobronchial forceps and there were no remaining fragments identified.Therefore, the investigation is confirmed for perforation of inferior vena cava, filter limb detachment and filter tilt.However, the investigation is inconclusive for retrieval difficulties.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 11/2012).

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.Approximately seven years and four months post filter deployment, it was alleged that the filter tilted, strut perforated , strut detached and the patient reportedly experienced pain.The device has been removed percutaneously.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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14460611
• MDR Text Key: 292227479
• Report Number: 2020394-2022-00390
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2022

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: GFVJ2453
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/20/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female