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

Model Number DL900F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Death (1802)

Event Date 10/11/2016

Event Type  Death  

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 deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.

Manufacturer Narrative

H10: 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.Approximately one week later, computerized tomography-abdomen/pelvis without contrast was performed which showed that the hook of the bard denali retrievable inferior vena cava filter was at the t12-l1 interspace.This was placed at a high juxta renal position.The inferior vena cava filter was not tilted.Two (2) of the struts of the inferior vena cava filter perforated the inferior vena cava up to 9mm.One posterior strut perforated the inferior vena cava wall and resides in the soft tissues.One (1) strut perforated the inferior vena cava wall laterally and was within the right renal vein.The patient reportedly expired.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava.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.H10: g4.H11: h6 (results, 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.

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 and pulmonary embolism.At some time post filter deployment, it was alleged that filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11258142
• MDR Text Key: 229598283
• Report Number: 2020394-2021-80141
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN, ATORVASTATIN, FUROSEMIDE, LISINOPRIL; ASPIRIN, ATORVASTATIN, FUROSEMIDE, LISINOPRIL; METOPROLOL TARTRATE, OMEPRAZOLE, PAROXETINE; METOPROLOL TARTRATE, OMEPRAZOLE, PAROXETINE; POLYETHYLENE GLYCOL, POTASSIUM CHLORIDE; POLYETHYLENE GLYCOL, POTASSIUM CHLORIDE; WARFARIN, VANCOMYCIN; WARFARIN, VANCOMYCIN; ASPIRIN, ATORVASTATIN, FUROSEMIDE, LISINOPRIL; METOPROLOL TARTRATE, OMEPRAZOLE, PAROXETINE; POLYETHYLENE GLYCOL, POTASSIUM CHLORIDE; WARFARIN, VANCOMYCIN
• Patient Outcome(s): Death
• Patient Age: 48 YR