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

Catalog Number	DL900F
Medical Device Problem Codes	Difficult to Remove (1528); Obstruction of Flow (2423); Migration (4003)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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 or Problem Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism and a hypercoagulable state of malignancy.Approximately two years and eight months post filter deployment, subsequent imaging demonstrated occlusion of the filter, and the patient allegedly experienced thrombosis, which required thrombolysis.It was further reported that the filter had allegedly migrated.Reportedly, the device has been removed percutaneously after unsuccessful attempts.The current status of the patient is unknown.
Additional 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.Medical records were provided and reviewed.Approximately three years, five months and twenty-eight days post filter implantation, the patient underwent removal of the filter due to left iliofemoral deep venous thrombosis.An indication for the procedure mentioned that the patient had a filter for recurrent pulmonary embolism and around ten months prior, the patient presented with acute onset of back pain and syncope, subsequent imaging demonstrated occlusion of the filter.At that point, the patient underwent thrombolysis of the filter which was unsuccessful complicated by a perinephric hematoma requiring blood transfusion.During the filter removal procedure, the right internal jugular vein was punctured, and an upsized wire was advanced into the inferior vena cava and subsequently into the right common iliac vein.Then a vascular sheath was advanced over the wire and positioned just above the level of the filter.A snare was advanced through the sheath to the apex of the filter.A catheter was advanced over the wire to just below the filter where it was allowed to reform and a glidewire advanced in a prograde fashion through the struts of the filter into the suprarenal inferior vena cava.Then the snare was advanced coaxially through the filter and used to snare the glidewire, which was brought out through the sheath as a through-and-through wire through the filter.The snare was advanced coaxially through the sheath and multiple attempts were made to snare the hook of the filter while exerting traction on the through-and-through wire to pull the filter away from the inferior vena cava wall but were unsuccessful.So, the snare was then withdrawn and transbronchial biopsy forceps were advanced through the sheath to just above the apex of the filter where the filter hook was engaged after manipulation in multiple oblique projections.The hook of the filter was engaged and the sheath was advanced over the transbronchial biopsy forceps and the filter.The filter was then retrieved through the sheath and close inspection of the filter as well as fluoroscopy following retrieval demonstrated a complete extraction of the filter.Post procedural findings and impressions were provided which showed that an initial fluoroscopy prior to filter removal demonstrated inferior vena cava to be widely patent and a bard denali filter in place at the level of l1 with the tip just at the level of the renal vein inflow.Initial contrast imaging also demonstrated no thrombus within the filter or the inferior vena cava.Also, the filter was minimally tilted anteriorly and there was some evidence of strut penetration of the inferior vena cava.Post removal impression showed successful retrieval of the filter using a transbronchial biopsy forceps and completion imaging demonstrated the inferior vena cava to be widely patent with some irregularity and flow disturbance at the site where the filter had been.Therefore, the investigation is confirmed for obstruction of flow, filter migration 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.H3 other text : device not returned.
Event or Problem Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism and a hypercoagulable state of malignancy.Approximately two years and eight months post filter deployment, subsequent imaging demonstrated occlusion of the filter, and the patient allegedly experienced thrombosis, which required thrombolysis.It was further reported that the filter had allegedly migrated.Reportedly, the device has been removed percutaneously after unsuccessful attempts.The current status of the patient is unknown.

• Brand Name: DENALI FEMORAL SYSTEM
• Common Device Name: 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: 17708890
• Report Number: 2020394-2023-00662
• Device Sequence Number: 17887907
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female