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

Catalog Number	DL900F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/29/2015
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 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 deployed successfully, in a patient with recurrent pulmonary emboli.It was further reported that in ten months five days post a filter deployment, patient was allegedly diagnosed with thrombosis and thrombus above the filter.Reportedly, the device has been removed.The current status of the patient was unknown.
Event or Problem Description
It was reported through the litigation process that a vena cava filter was deployed successfully in a patient after being diagnosed with recurrent pulmonary emboli.It was further reported that ten months and five days post a filter deployment, patient was allegedly diagnosed with thrombosis and thrombus above the filter.Reportedly, the device has been removed.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 is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately ten months and five days post filter deployment, patient had inferior vena cava occlusion with bilateral extremity deep vein thrombosis.Through the right internal jugular access, a vena cavogram was performed which showed occlusion of the inferior vena cava with fragmented clot above the filter.Around one day later, patient had thrombus in the left iliac system with thrombosis of filter.Patient initiated with thrombolytic therapy yesterday and underwent percutaneous mechanical thrombectomy of the profunda femoral vein.A balloon angioplasty was performed using balloon in the distal common femoral vein due to still residual thrombus in the iliac system.I performed angioplasty in the right common femoral vein and right iliac vein using a balloon.Also, selective catheter placement in the superficial femoral vein demonstrated that it largely appeared to be free of thrombus from the level above the popliteal vein up to the common femoral vein.Due to the thrombus in the filter, we performed balloon angioplasty using a balloon through and across the sheath.Completion venogram demonstrated a significant residual thrombus within the filter.Around one day later, patient had the filter occlusion and bilateral lower extremity deep vein thrombosis.The venogram was performed showed the filter appears to be with tremendous clot burden below and above the filter.A percutaneous thrombectomy was done of the filter.Tremendous amount of clot was removed.There was still occlusion of the filter just below the cone of the inferior vena cava.Based on the conical in shape of the filter, decided to remove the filter and replace it with brand new filter.This was done with a cook gunther tulip inferior vena cava gooseneck snare system and the filter was removed.Then a new inferior vena cava jugular bard denali was then taken just below the renal veins and deployed without tilt.Around one year and six months later, through the left common femoral vein approach, a venogram was performed which demonstrated presence of thrombus starting in the most central portion of the external iliac vein.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.Based upon the available information, the definitive root cause is unknown.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 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.

• Brand Name: DENALI FEMORAL SYSTEM
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 18638310
• Report Number: 2020394-2024-00163
• Device Sequence Number: 7731776
• 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: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/22/2024
• 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: 47 YR
• Patient Sex: Female
• Patient Race: Black Or African American