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

Catalog Number UNKNOWN FILTER

Device Problems Difficult to Remove (1528); Migration (4003)

Patient Problem Cardiac Perforation (2513)

Event Date 10/17/2007

Event Type  Injury  

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient and the reason for deployment was not provided.At sometime post filter deployment, it was alleged that the filter was migrated to the right atrium and the filter perforated into the right atrium.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.However, the current status of the patient is unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Date of event was entered as date of awareness due to system limitations, since date of event was unknown.Device not returned.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, one year three months of post deployment, an x-ray of chest was performed.The study showed that a filter device was noted in the region of the right atrium.Around, two years and four months later, in a pre-operative physician evaluation, it was mentioned that the patient had an inferior vena cava filter and an x-ray study of last year surprisingly showed evidence for migration of inferior vena cava filter to the right atrium.However, at the current time, the x-rays were reviewed which certainly confirmed that the vena cava filter was in the right atrium.Discussions were made between the physicians for further review of the x-rays and to see whether it was retrievable from a percutaneous approach.After, nineteen days, an attempt was made to retrieve the right atrial foreign body, presumed to be the inferior vena cava filter.Initially venous access was obtained from a right common femoral vein approach with ultrasound and fluoroscopic guidance.A filter was noted to be present within the inferior vena cava.However, upon questioning the patient, she was unaware when this might have been placed.Therefore, attention was directed to the right internal jugular vein for access.Ultrasound and fluoroscopic guidance were again used to facilitate venous access and a 6-french sheath was placed.A 6-french snare was advanced into the right atrium and used to select the struts of the device.Multiple struts could easily be snared on several occasions, but the device was fixed in place and the procedure was then terminated.Finally, it was concluded with an unsuccessful right atrial foreign body retrieval.Therefore, the investigation is confirmed for the filter migration and 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.H10: g3, h6(method) h11: b3,h6(result and conclusion) h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient and the reason for deployment was not provided.At sometime post filter deployment, it was alleged that the filter was migrated to the right atrium and the filter perforated into the right atrium.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.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 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13266368
• MDR Text Key: 283957839
• Report Number: 2020394-2022-00011
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• 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
• Date Manufacturer Received: 02/02/2022
• 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
• Treatment: BACLOFEN, AMBIEN, WARFARIN, COLESTID; BACLOFEN, AMBIEN, WARFARIN, COLESTID; COUMADIN, VICODIN, OXYCONTIN, FENTANYL; COUMADIN, VICODIN, OXYCONTIN, FENTANYL; ZONEGRAN, NEXIUM, ADVAIR, DARVOCET AND ALLEGRA; ZONEGRAN, NEXIUM, ADVAIR, DARVOCET AND ALLEGRA
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Race: White