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

Catalog Number UNKNOWN FILTER

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2004

Event Type  malfunction  

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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient for deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that the filter had migrated.The device was removed successfully.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient for deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that the filter had migrated.The device was removed successfully.The current status of the patient is unknown.

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.Medical records were provided and reviewed.The medical records allege inferior vena cava filter was implanted for a patient.The inferior vena cavogram confirmed appropriate placement of the filter.There were no immediate complications.Approximately one month later, the patient reported to the hospital for abdominal pain.An ultrasound was performed, and the inferior vena cava filter was identified with no definite clots.However, on the same day, the filter was had shown migration and was retrieved.Therefore, the investigation is confirmed for the alleged filter migration.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.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.

• 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
• MDR Report Key: 12352727
• MDR Text Key: 267626158
• Report Number: 2020394-2021-01491
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• 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: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPHETAMINE-DEXTROAMPHETAMINE, ASPIRIN; AMPHETAMINE-DEXTROAMPHETAMINE, ASPIRIN; ESCITALOPRAM, FONDAPARINUX; ESCITALOPRAM, FONDAPARINUX; GABAPENTIN, AND SUMATRIPTAN; GABAPENTIN, AND SUMATRIPTAN; AMPHETAMINE-DEXTROAMPHETAMINE, ASPIRIN; ESCITALOPRAM, FONDAPARINUX; GABAPENTIN, AND SUMATRIPTAN
• Patient Age: 25 YR
• Patient Weight: 65