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

Catalog Number UNK DENALI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 08/27/2014

Event Type  Injury  

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 after being diagnosed with extensive right lower extremity deep vein thrombosis and pulmonary embolism.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post filter implant; however, 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 after being diagnosed with extensive right lower extremity deep vein thrombosis and pulmonary embolism.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post filter implant; however, the current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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: DENALI FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11670322
• MDR Text Key: 249203909
• Report Number: 2020394-2021-00858
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK DENALI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METHADONE HYDROCHLORIDE; METHADONE HYDROCHLORIDE; ONDANSETRON HYDROCHLORIDE; ONDANSETRON HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE; XARELTO, ATORVASTATIN CALCIUM, LOPERAMIDE; XARELTO, ATORVASTATIN CALCIUM, LOPERAMIDE
• Patient Outcome(s): Life Threatening
• Patient Age: 41 YR
• Patient Weight: 112