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

Catalog Number MD800F

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

Patient Problem Pain (1994)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and two months later, a computed tomography (ct) abdomen without contrast was performed and it revealed there was an inferior vena cava filter in place.The tip/cephalad end of the filter was located 0.5cm below the confluence of the left renal vein and inferior vena cava.The filter was tilted anteriorly, and the tip of the filter contacts the anterior wall of the inferior vena cava.The tips of the two of the posterior struts of the filter extend beyond the margin of the posterior wall of the inferior vena cava.A fat plane was visualized between these 2 limbs and the posterior wall of the inferior vena cava.This was suggestive of a chronic perforation.One of the posterior medial struts of the extends into a lumbar vein.Therefore, the investigation is confirmed for alleged filter tilt 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.(expiry date: 07/2014).

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.At some time post filter deployment, it was alleged that filter tilted and struts perforated the inferior vena cava wall and lumbar vein.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal and back pain, however: 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: 10342730
• MDR Text Key: 200961348
• Report Number: 2020394-2020-05214
• 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: 07/30/2020

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: GFXF2753
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/30/2020
• 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: LOVENOX, LEVOTHYROXINE AND COUMADIN
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 238