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

Catalog Number UNKNOWN FILTER

Device Problems Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Abdominal Pain (1685)

Event Date 06/07/2013

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.Post filter deployment, a computed tomography abdomen and pelvis showed an indwelling inferior vena cava filter.The distal legs of the filter were contracted together and the inferior vena cava appeared to be scarred down around it.This looked like a type filter.The inferior vena cava above the filter was partially flattened, but looked patent.Two years and three months later, the patient presented with abdominal pain.On the same day, a computed tomography abdomen and pelvis showed that an inferior vena cava filter was present, with the surrounding vasculature partially collapsed; however, unchanged from two years ago.Next day, an x-ray abdomen anteroposterior demonstrated that an inferior vena cava filter was observed.After 2 days, an ultrasound venous lower extremity bilateral with compression showed no evidence of acute deep venous thrombosis or venous occlusion.Around 3 years and 10 months later, multiple axial images using computed tomography abdomen showed that an inferior vena cava filter was in place.It had a vertical orientation.The apex did not appear to touch the inferior vena cava wall.The tip of the inferior vena cava filter was 1.5 cm below the level of the right renal vein.The struts were patent proximally and extended outside of the inferior vena cava with the maximum amount of perforation being 5 mm.They did not appear to involve any adjacent structures.Therefore, the investigation is confirmed for perforation of the inferior vena cava and material deformation.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 unknown medical complication.At some time post filter deployment, a computed tomography (ct) abdomen and pelvis without contrast revealed that the distal legs of the filter were contracted together and struts extended outside of the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.

• Brand Name: VENA CAVA FILTER
• 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: 11869876
• MDR Text Key: 252167880
• Report Number: 2020394-2021-80460
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/24/2021

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: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/24/2021
• 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: MIRALAX, VESICARE AND JUVEN; XANAX, CIPRO, FLEXERIL AND DOLOPHINE
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 66