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

Model Number DL900F

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685)

Event Date 12/14/2015

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.A bard denali filter was deployed with its tip at the l1/l2.Approximately four months of post deployment, a computed tomogram angiography study was performed which showed acute pulmonary embolism right upper lobe.Around four months later, a computed tomography of abdomen and pelvis was performed, which showed interval placement of inferior vena cava filter with several of the prongs extending beyond the inferior vena cava lumen.Around two months later, an x-ray abdomen was performed for abdominal pain, which showed inferior vena cava filter was noted at l2 level.A computed tomography angiogram of chest was performed for chest pain.The study showed that mildly limited evaluation for acute pulmonary thromboembolus.Around six months later, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was noted at the l2 level.One strut from the filter extends into the right gonadal vein.Around twenty-one days later, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was noted in a stable position with struts again seen extending beyond the wall of the inferior vena cava but without acute inflammatory change.Around seventeen days later, a computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted at the l2-l3 level.Around four months later, a computed tomography of abdomen and pelvis was performed for right lower quadrant abdominal pain.The study showed that inferior vena cava filter was noted at the level of l2-l3.Therefore, the investigation is confirmed for filter migration and perforation of the inferior vena cava (ivc).Additionally, it can be confirmed that the patient experienced pulmonary embolism 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 hospitalized for gi bleed due to supratherapeutic coumadin.At some time post filter deployment, it was alleged that the filter struts perforated into organs.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 FEMORAL 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: 12305749
• MDR Text Key: 265966383
• Report Number: 2020394-2021-80694
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• 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: 07/15/2021
• 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: ALBUTEROL, BACLOFEN, BISACODYL AND DOCUSATE; DOXEPIN, FUROSEMIDE AND GABAPENTIN; LEVOTHYROXINE, METHOCARBAMOL AND ONDANSETRON; OXYBUTYNIN, OXYCODONE AND RANITIDINE; RIBOFLAVIN, SIMVASTATIN AND TRAZODONE
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 57 YR
• Patient Weight: 65