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

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 09/26/2016

Event Type  Death  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, eight years and four months of post-deployment, computerized tomography angiogram abdomen/pelvis aorta was performed which showed that an inferior vena cava filter present mid l2 to sup l4.There was significant anterior tilt (on coronal 13 degrees to right and 21 degrees tilt anteriorly on sagittal images).There was grade 3 perforation, right posterior strut embedded psoas muscle and ventral struts abuts duodenum.There was broken strut along posterior wall of inferior vena cava.Around, eleven months and twelve days later, the patient with a history of inferior vena cava filter placement during repair of a type a dissection, during which the patient had a pulmonary embolism.The patient was referred for filter removal and was concerned enough about potential complications to want it removed.The patient has an abdominal x-ray which shows a filter angled anteriorly, and apparently one strut which was fractured.Attempted endovascular removal of inferior vena cava filter.Preoperative imaging showed a fractured strut from the filter as well.The patient scheduled for inferior vena cava filter removal.The right jugular vein and right common femoral vein were accessed with ministick needles and sheaths under direct ultrasound guidance, and short sheaths were placed.A benson wire was passed into the inferior vena cava with the assistance of a bern catheter, and a contra catheter placed below the filter to obtain a venogram.No thrombus was noted.An amplatz wire was placed and a 30cm 18fr sheath was placed in the neck, with a 45cm 14fr sheath inside it.The contra catheter was placed below the filter again, and a glide wire advanced around the filter struts and snared.When attempted to capture the filter, the struts pulled superiorly but the filter was not captured in the sheath.Then did attempt to loop the wire around different struts, but ultimately were unsuccessful due to the filter tip being embedded in the wall of the inferior vena cava.Then decided to terminate the procedure at this point to avoid disrupting the filter further.Patient tolerated above procedure well.An inferior vena cava filter would not be removed as it was embedded in wall.Around, one month and twenty-five days later, the patient presented with flank pain.An x-ray abdomen 1 view showed an inferior vena cava filter was noted at the l3-4 position.Around, three months and nineteen days later, the patient with a history of indwelling inferior vena cava filter who presented after multiple failed attempts at endovascular retrieval.Patient has chronic back pain and evidence of fractured filter on previous imaging.Then the patient admitted by vascular surgery for open inferior vena cava filter retrieval.The patient was taken to the operating room and placed in supine position.General anesthesia was induced.The abdomen from the level of the nipples to the knees were prepped and draped in usual sterile fashion.A right subcostal incision was made with a 10 blade and deepened with bovie electrocautery, and the peritoneum entered.The right colon was reflected medially, exposing the inferior vena cava and the right and left renal veins.At this time, the suprarenal segment was identified, and umbilical tape was placed around the infra renal inferior vena cava just above the level of the filter in an infra renal inferior vena cava below the level of the inferior vena cava filter.Proximal and distal clamps were placed.The cava opened with 11 blade and extended with potts scissors.A 7- (b)(6) sheath with a prolene sling was used to snare the filter and re-sheath the filter inside the sheath.The broken fragment of the filter was found on the posterior wall and manually extracted.Fluoroscopy was used to confirm there were no other metallic fragments left in the abdomen and the filter examined under fluoroscopy and reconstructed to ensure all pieces were present and accounted for.Successfully extracted inferior vena cava filter with no remaining metallic fragments left in the abdomen under fluoroscopy.Gross section stated that container received without fixative, labeled with the patient's name and "miscellaneous gross only- inferior vena cava filter", was a metallic inferior vena cava filter that measures 4.5 cm in length and has a base piece that was 0.4 x 0.1 cm and was metallic.From the base piece there were multiple metallic flat wires that branch in an arborizing pattern.The patient reportedly expired.Therefore, the investigation is confirmed for filter tilt, filter limb detachment, retrieval difficulties and perforation of the inferior vena cava (ivc).Per medical records, multiple attempts were made to engage the apex of the filter using snare but were unsuccessful due to filter tilt and perforation of the inferior vena cava (ivc).This could have contributed to the retrieval difficulties.However, 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.(expiry date: 04/2011).

Event 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 and embedded in the wall of inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter and the detached struts retained in the wall of inferior vena cava.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: 12369096
• MDR Text Key: 268193299
• Report Number: 2020394-2021-80707
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: GFSD1777
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• 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: ACYCLOVIR, ALBUTEROL, ATENOLOL, AZELASTINE HCL; CETIRIZINE HCL, CHOLECALCIFEROL, CYANOCOBALAMIN; DICLOFENAC SODIUM, DOCUSATE SODIUM; FLUTICASONE PROPIONATE, GUAIFENESIN-CODEINE; IPRATROPIUM BROMIDE, LISINOPRIL, MECLIZINE HCL; LEVOCETIRIZINE DIHYDROCHLORIDE; LORAZEPAM, OXCARBAZEPINE; MONTELUKAST SODIUM, OMEGA-3 FATTY ACIDS
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 71