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

Catalog Number DL900F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 11/30/2020

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.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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary thromboembolism.Six months and ten days post filter deployment, it was alleged that the filter had detached, material deformed, perforated, and the filter tilted.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.The denali ivc filter is deployed in what is presumed to be the inferior vena cava.The tip of the filter is at the l1-l2 disc level.It is upright with no significant tilt.The struts all appear to be deployed.Medical records were provided and reviewed.Approximately six months and ten days post filter implantation, retrieval of the filter was performed.The right internal jugular vein was accessed using real-time ultrasound guidance.A 21-gauge micro-introducer needle was used to access the vein.A 0.018-inch cope wire was advanced into the superior vena cava.The needle was then exchanged for a 4-french micro-introducer sheath.The inner dilator and wire were removed and a 0.035-inch amplatz wire was placed into the inferior vena cava.The micro-introducer sheath was then removed.A 11-french coaxial bard retrieval kit was then advanced into the right iliac vein.An inferior venacavogram was performed demonstrating a patent inferior vena cava with bilateral renal inflow artifacts.There was flow void identified at the tip of the filter.The indwelling filter was attempted to be snared with the snare within the kit, followed by a amplatz goose-neck snare but the snare was not successful.Several attempts with various endobronchial forceps were attempted with minimal success.Oblique venograms were then performed demonstrating that the hook of the filter was within the right renal vein.The forceps were able to grasp the apex of the filter but were unsuccessful in efforts to try and gravity hook.Using a snare and a sos catheter, a micro-wire was used to surround the filter and was attempted to be retracted into the sheath however this failed.The decision was made then to abort the procedure as procedural time was elevated and likely a femoral approach may be required.A final venogram demonstrated filter positioning within the inferior/right renal vein, a few of the filter legs were flipped cranially.The wire and catheter were removed without difficulty.The right internal jugular sheath was removed, and hemostasis was attained.The patient tolerated the procedure well.There were no immediate complications.Around seventeen days later, repeat retrieval of the filter was performed.A scout radiograph revealed the filter tilted to the right and partially fractured.Under ultrasound guidance, a 21-gauge micro-introducer needle was used to access the right internal jugular vein.A 0.018-inch cope wire was advanced into the superior vena cava.The needle was then exchanged for a 4-french micro-introducer sheath.The inner dilator and wire were removed and a 0.035-inch amplatz wire was placed into the inferior vena cava.The micro-introducer sheath was then removed.A long 16-french vascular sheath was then placed over the wire.Venogram through the femoral sheath demonstrated no thrombus surrounding the filter.Using forceps, the three superiorly positioned prongs were repositioned inferiorly, one of which was removed after fracturing.Numerous attempts to retrieve the filter were unsuccessful using forceps, snare, and loop snare with a reverse curve catheter technique.Multiple venograms in multiple obliques and projections demonstrate the filter tip protruding posteriorly beyond the inferior vena cava wall within the retroperitoneum.No extravasation was noted.All wires, catheters, and sheaths were removed.Hemostasis was obtained with manual pressure.The patient tolerated the procedure well.There were no immediate complications.Therefore, the investigation is confirmed for the reported filter detachment, deformation, perforation of inferior vena cava, filter tilt and retrieval difficulties.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 pulmonary thromboembolism.Six months and ten days post filter deployment, it was alleged that the filter had detached, material deformed, perforated, and the filter tilted.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.There was no reported patient injury.

• 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17689456
• MDR Text Key: 322709676
• Report Number: 2020394-2023-00652
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2023
• 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
• Patient Age: 51 YR
• Patient Sex: Male