MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF310F

Device Problem Malposition of Device (2616)

Patient Problems Pulmonary Embolism (1498); No Consequences Or Impact To Patient (2199); Thrombosis/Thrombus (4440)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was not returned.Images and medical records were not provided.The investigation is inconclusive for a tilted filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.- filter tilt.- filter malposition.Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.Precautions: - procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter.

Event Description

It was reported that approximately six years post filter deployment, the patient presented to the emergency department for complaint of leg pain.Patient was identified with dvt, clotting and substantial venous congestion.The vena cava filter was alleged to have tilted.Upon further consultation with the physician the decision was made to leave the filter in place due to the dvt.The patient remains on anticoagulation.The patient status at this time is unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned.Images and medical records were not provided.Therefore, the investigation is inconclusive for a tilted filter as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.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 that approximately six years post filter deployment, the patient presented to the emergency department for complaint of leg pain.Patient was identified with dvt, clotting and substantial venous congestion.The vena cava filter was alleged to have tilted.Upon further consultation with the physician the decision was made to leave the filter in place due to the dvt.The patient remains on anticoagulation.The patient status at this time is unknown.It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the ivc.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a 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.Approximately, six years and five months of post deployment, bilateral lower extremity venography, inferior vena cavography, bilateral lower extremity mechanical thrombectomy (mechanical extraction of blood clot) and initiation of tissue plasminogen activator thrombolysis bilaterally was performed for a patient with deep vein thrombosis.Review of prior computed tomography scan images showed extension of thrombus above the inferior vena cava filter.A guidewire and catheter were negotiated into the iliac venous system confirming thrombosis across both the common and external iliac veins with extensive thrombus trapped into the filter.The filter was crossed confirming trailing thrombus above the inferior vena cava filter over a few centimeters to just below the level of the renal veins.The filter was tilted.There was brisk flow of un opacified blood flow from the renal veins into the suprarenal inferior vena cava which was patent.The inferior vena cava filter was crossed into the suprarenal component.Adequate hemostasis stopping of flow of blood was achieved.The patient tolerated the overall procedure.On the same day, computed tomography angiogram scan of chest with and without contrast, computed tomography angiogram scan of abdomen and pelvis with and without contrast was performed which showed an infra renal inferior vena cava filter remains in place.Impression given: bilateral pulmonary embolism with most of the embolic burden in the lower lobe segmental and sub segmental arteries.On the next day, interventional radiology continuation of lysis sub day was performed which showed there was partial lysis of clot within the infra renal inferior vena cava with thrombus trapped into the inferior vena cava filter with near occlusion at this level.Suspected interval lysis of suprarenal filter extension of thrombus.Elected to proceed with repeat mechanical thrombectomy.A possis thrombectomy device was again used to further macerate and clear clot across the right iliofemoral veins into the inferior vena cava and particularly to clear clot across the filter.Mechanical thrombectomy was also performed across the residual clot of left iliac veins into the inferior vena cava, and from a different approach across the inferior vena cava filter.Completion study showed an overall significant clearing of residual clot with now patent bilateral iliac veins and the right common femoral vein into the infra renal inferior vena cava with some residual clot into the filter though with better antegrade flow across this level.Elected to continue tissue plasminogen activator lysis to clear residual clot.On the next day, interventional radiology completion of lysis was performed.Follow-up venography performed showing essentially complete lysis of clot across both iliac veins and the inferior vena cava with some residual minimal thrombus still trapped within the filter.There was better alignment of the filter and there was brisk flow across this level.Due to overall significant improvement, further intervention not required, and the procedure concluded.Therefore, the investigation is confirmed for filter tilt.Additionally, it can be confirmed that the patient experienced pulmonary embolism (pe) post deployment and 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: 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.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 in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the ivc.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: G2 FILTER SYSTEM - FEMORAL
• 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: 6153337
• MDR Text Key: 61773183
• Report Number: 2020394-2016-01137
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• 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: WELLBUTRIN (BLOOD THINNER)
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Race: White