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

Model Number DL900J

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the 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 year and three months of post deployment, computerized tomography- lumbar spine without contrast was performed which showed that there was an asymmetric retrievable bard/greenfield style filter projecting with its tip directed superiorly.The tip projects over the right l3 transverse process.Note, on computerized tomography the inferior vena cava filter was slightly tilted and several other tines project beyond the margin of the inferior vena cava.One year and one month later, the patient admitted with cough and chest pain.Six days later, the patient indicated with recurrent pulmonary embolism with filter.The patient had a computerized tomography scan of the abdomen and chest x-ray that showed some pulmonary nodules.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt as the medical record states "the inferior vena cava filter was slightly tilted".Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.Based upon 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 deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted and embedded in wall of the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: DENALI JUGULAR SYSTEM
• 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: 11918598
• MDR Text Key: 253810108
• Report Number: 2020394-2021-80474
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• 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: ATENOLOL, COLACE, NICOTINE, NORCO; CYANOCOBALAMIN, DIGOXIN, FUROSEMIDE; DOXYCYCLINE, OMEPRAZOLE, RIVAROXABAN, METOPROLOL; GABAPENTIN, GLIMEPIRIDE, METOPROLOL, MICONAZOLE; IBUPROFEN; METOPROLOL, LASIX, RIVAROXABAN; MORPHINE, SAXAGLIPTIN, METHOCARBAMOL; MULTIVITAMIN, OXYCODONE-ACETAMINOPHEN; RIVAROXABAN, TAMSULOSIN, TRAMADOL, TRAZODONE; TERAZOSIN, AUGMENTIN, ISONIAZID, METOLAZONE; THIAMINE, IPRATROPIUM-ALBUTEROL, CEFTRIAXONE; VITAMIN D, PREDNISONE, ACETAMINOPHEN; XARELTO, ATRIAL FIBRILLATION, ATORVASTATIN
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR
• Patient Weight: 181