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

Catalog Number	DL900F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Chest Pain (1776); Insufficient Information (4580)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years, seven months and twenty-three days post filter placement, the patient presented with chest pain.Examination revealed that inferior vena cava filter could be partially visualized in the abdomen.Around two years and eight months later, it was discovered that a strut from the inferior vena cava filter had migrated into the right ventricle.Around some days later, the patient died, and cause of death was complications of metastatic lung cancer.Around eleven days later, autopsy was performed, and the results included that a metal strut consistent migration from the inferior vena cava filter was recovered from the right ventricle with one end in the leaflet of the tricuspid valve, and the other end in the intraventricular septum.The strut is removed and retained.An inferior vena cava was in place with a small amount of adherent thrombus.The vena cava filter was removed and retained.Therefore, the investigation is confirmed for the reported filter strut detachment.Based upon the available information, the definitive root cause is unknown.This complaint is involved with litigation.Based on the review of the death certificate, it has been determined that the patient expired due to metastatic lung cancer.Therefore, no additional action is required.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 06/2018) 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 litigation process that sometime post a filter placement the filter allegedly fractured, and strut migrated into the right ventricle.The patient allegedly experienced chest pain and later died due to complications of metastatic lung cancer.The filter was removed during autopsy.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six months and seven days post filter implantation, the patient experienced chest pain.Computed tomography angiogram of chest showed there were no filling defects that suggest pulmonary emboli and upper abdomen showed a vena cava filter.Around nineteen days later, the patient experienced chest pain.Single view of abdomen showed there was a filter with its tip at the inferior endplate of l1 and its distal legs overlying the superior endplate of l3.There were no reported complications.Around eight months and nineteen days later, the patient experienced precordial chest pain.X-ray of chest in posteroanterior and lateral views were performed which showed the filter.Around two years, four months and seven days later, the patient presented with chest pain.Computed tomography revealed that the filter partially visualized in the upper abdomen.Around one year, ten months and ten days later, the patient experienced pain.X-ray of chest showed the filter.Around ten months later, it was discovered that a strut from the inferior vena cava filter had migrated into the right ventricle.Around some days later, the patient died, and cause of death was complications of metastatic lung cancer.Around eleven days later, autopsy was performed, and the results included that a metal strut consistent migration from the inferior vena cava filter was recovered from the right ventricle with one end in the leaflet of the tricuspid valve, and the other end in the intraventricular septum.The strut is removed and retained.An inferior vena cava was in place with a small amount of adherent thrombus.The vena cava filter was removed and retained.Therefore, the investigation is confirmed for the reported filter strut detachment.Additionally, it can be confirmed that the patient experienced chest pain post filter deployment.However, the relationship with the filter is unknown.Based upon the available information, the definitive root cause is unknown.This complaint is involved with litigation.Based on the review of the death certificate, it has been determined that the patient expired due to metastatic lung cancer.Therefore, no additional action is required.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 06/2018).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 three years, seven months, and twenty-one days post a vena cava filter placement via the right common femoral vein, it was alleged that the filter strut had detached and migrated into the patient's right ventricle.It was further reported that the patient allegedly experienced chest pain and later died due to complications of metastatic lung cancer.However, the relationship of the death was not related to the device.Reportedly, the filter was removed during autopsy.

• 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: 18957253
• Report Number: 2020394-2024-00376
• Device Sequence Number: 18464365
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: GFZE3699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/25/2024
• 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