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

Model Number	2120F
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Abdominal Pain (1685); Foreign Body In Patient (2687)
Date of Event	07/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 nine years and one month later, a computed tomography abdomen and pelvis without runoff was performed on patient with venous stenting for chronic recurrent deep venous thrombosis, noting patent inferior vena cava filter in the lower abdomen with no evidence of thrombus.The images showed a chronically embedded infrarenal simon-nitinol filter with tip embedded along the anterior caval wall.There was multifocal penetration into the retroperitoneum, adjacent aorta, retroaortic space, adjacent vertebral body, and adjacent right psoas muscle.There was possible chronic thrombus along the left common and external iliac vein stents.After two days, patient with a history of venous stenting for chronic deep venous thrombosis underwent complex inferior vena cava filter removal laterally complicated by filter legs penetration into the retroperitoneum and aorta and left iliofemoral stent venoplasty.Scout abdominal radiograph demonstrated a simon-nitinol inferior vena cava filter with at least 2 fractures.Left iliocaval venogram demonstrated no acute thrombus.Subsequent intravascular ultrasound of the left iliac stents confirmed moderate to severe in-stent stenosis along the left common iliac venous stent and proximal external iliac venous stent.Using ultrasound guidance, the right internal jugular vein was accessed with a micropuncture set.An amplatz wire was advanced into the inferior vena cava below the level of the inferior vena cava filter.An 18 french x 25 cm dryseal sheath was advanced over the wire.A 14 french sheath was placed coaxially.The amplatz wire was exchanged for a glidewire.A modified flush omni catheter was advanced over the glidewire in order hook through the umbrella aspect of the simon nitinol filter.A trilobed snare was then advanced parallel through the sheath and used to engage the wire tip.This was pulled through the neck to form a wire loop.Rigid forceps were then advanced through the sheath in parallel and used to dissect free the embedded filter apex.The 14 fr sheath was found to be too small; therefore, the sheath was exchanged over the wire loop for an 18 fr dissector sheath.A 16 fr laser sheath was calibrated per protocol and inserted coaxially.The rigid forceps were readvanced to engage the apical aspect of the inferior vena cava filter, and this was sheathed.The dissector was used to capture the filter.The coaxial system was exchanged for the original 18-fr dryseal sheath.Rigid forceps were advanced through the sheath to engage a filter fragment and remove it from the lumen.Post retrieval vena cavogram demonstrated a small pseudoaneurysm with no extravasation and no enlargement.After three days, a computed tomography abdomen with contrast was performed on patient with difficulty urinating and abdominal/testicular pain post filter removal, demonstrating to have postprocedural interventional radiology complication of retroperitoneal hematoma, hydroureteronephrosis, mildly delayed enhancement and excretion, and mass effect on ureter from adjacent retroperitoneal hematoma with possible ureteral injury.Post inferior vena cava filter removal with single posterior filter leg was noted remaining in place.After one month, a doppler ultrasound for abdomen evaluation was performed on patient with residual pseudoaneurysm and persistent right scrotal swelling and testicular pain, noting interval decrease in size of the retroperitoneal hematoma around the distal inferior vena cava.The collection was predominantly hypoechoic, indicating liquefaction of the evolving hematoma.There was a focal contour abnormality of the inferior vena cava with color flow directed towards the hematoma, but no flow within the hematoma itself.Patent inferior vena cava and iliac veins, including the stented left common and external iliac veins were noted.Nonocclusive thrombus in the left common femoral vein was also noted.After eight months, patient reportedly experienced abdominal pain, left leg pain, and blood in stool.After five months, a computed tomography abdomen was performed for evaluation of possible retained inferior vena cava filter, noting significant for partially retained fragments as well as additional other stable findings such as liver cysts, recurrent deep vein thrombosis history not requiring immediate medical attention.After two weeks, patient underwent an esophagogastroduodenoscopy/colonoscopy after reportedly having both bright red blood per rectum and melena in the setting of epigastric abdominal pain and recently switching from warfarin to xarelto for management of his chronic deep vein thrombosis.After eleven days, patient reportedly experienced odynophagia, chest pain, shortness of breath, and epigastric pain.Therefore, the investigation is confirmed for the alleged filter limb detachment, perforation of inferior vena cava.However, the investigation is inconclusive for the alleged filter tilt.Based on 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.
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 deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted, struts detached and perforated into retroperitoneum and aorta.The device and the detached struts were removed percutaneously.It was further reported that the detached strut retained in abdomen/pelvis; however, the current status of the patient is unknown.

• Brand Name: SIMON NITINOL FILTER SYSTEM
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12546026
• Report Number: 2020394-2021-80724
• Device Sequence Number: 1113257
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K970099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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 Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE, BACITRACIN-POLYMYXIN B, CLINDAMYCIN; CLOPIDOGREL, FAMOTIDINE, AND WARFARIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Weight: 103