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

Catalog Number MD800F

Device Problems Activation, Positioning or Separation Problem (2906); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 11/21/2012

Event Type  Injury  

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.Medical records were provided and reviewed.The proximal aspect of the filter was engaged into the left lateral position of the vena cava wall.This did not allow for proper deployment of the legs of the filter.A snare was used to grasp the proximal aspect of the filter with attempts at repositioning of the filter but unsuccessful and the patient experienced pain with attempts at dislodging the already implanted filter.It appeared due proximal aspect of the filter engaged the right renal vein.Despite multiple attempts, this was unsuccessful in repositioning.Then second meridian filter was successfully deployed in an infrarenal position.Malpositioning of initial filter extending into the right renal vein.Approximately five years and eleven months post filter deployment, computed tomography (ct) revealed that inferior vena cava filter was tilted 32 degrees laterally and one of the structs extends laterally and contact the anterior margin of a vertebral body.The inferior portion of the filter demonstrates strut penetration to 4mm.The tip of the filter resides just below the right renal vein.Therefore, the investigation is confirmed for positioning issue, deployment issue and perforation of the inferior vena cava (ivc).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 and pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated, deployment issue and positioning issue.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced pain; however, 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: 10533651
• MDR Text Key: 206940634
• Report Number: 2020394-2020-05642
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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: 08/19/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 48 YR