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 Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Thrombosis/Thrombus (4440)

Event Date 10/12/2010

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.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.Bard removable infrarenal g2 filter was deployed.Approximately four years and eight months of post deployment, a computed tomography of abdomen and pelvis was performed for right sided abdominal and pelvic pain.The study showed that large clot from the inferior vena cava filter extending into the iliac veins bilaterally.The etiology of the occlusion may be both trapped clot and secondary thrombosis.The clot extends superiorly above the renal veins in the inferior vena cava below the filter appears to be distended as does the iliac and femoral veins on both sides.The next day, a cook inferior vena cava filter was placed at suprarenal inferior vena cava due to extension of thrombus above the existing filter.Around two months later, patient was planned for filter removal.Through the right internal jugular vein approach, a catheter was placed and positioned just below the suprarenal filter.Digital subtraction angiography was performed demonstrating no evidence of thrombus within the filter; however, the filter was significantly tilted to the right with the hook of the filter directed laterally.Multiple attempts at pulling the apex of the filter away from the wall were made, however the sheath could still not be advanced over the wire to recapture the apex.A completion venogram was performed demonstrating no evidence of perforation.Around five years and nine months later, patient with inferior vena cava occlusion related to two filters.Patient was planned for removal of both the inferior vena cava filter with possible stent placement.Through the right internal jugular vein access, a catheter was advanced into the suprarenal inferior vena cava.Digital subtraction angiography demonstrates brisk flow through the suprarenal filter.The filter was somewhat tilted.The infra renal inferior vena cava was occluded and the previously placed inferior vena cava filter in the infra renal inferior vena cava was noted.The apex of the filter was clearly endothelialized against the inferior vena cava wall, a reverse curved catheter was placed underneath the neck of the filter.A glide wire was then advanced, and a snare used to secure the glide wire.After extensive manipulation and repositioning, the filter was able to be captured within the sheath and removed intact.Then advanced a glide wire through the old filter in the infra renal inferior vena cava, however attempts at recanalized in the occluded iliac vein stents were unsuccessful.Since in-line flow cannot be established through the stent, no need to remove the old filter and therefore sheath was removed.The suprarenal inferior vena cava appears normal after filter removal with no evidence of clot or perforation.Around eleven months later, a computed tomography of abdomen was performed for filter evaluation.The study showed that inferior vena cava filter located in a markedly atrophied inferior vena cava below the level of the renal arteries.The medial strut extends through the infra renal abdominal aorta with no periaortic hematoma.The more laterally located struts are outside the confines of the inferior vena cava with a strut extending to the l3 vertebral body margin.The struts of the inferior vena cava filter are not fractured.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc), filter tilt and retrieval difficulties.Per medical records, multiple attempts were made to engage the apex of the filter but were unsuccessful due to filter tilt and perforation of 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: 12/2008).

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, struts perforated and the patient experienced abdominal pain.The device was removed percutaneously after an attempted but unsuccessful percutaneous removal procedure.It was further reported that thrombosis was observed above the filter; however, 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: 12133974
• MDR Text Key: 260451942
• Report Number: 2020394-2021-80547
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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: GFPK3271
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2005
• 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: CYCLOBENZAPRINE AND OXYCODONE; LOVENOX AND COUMADIN; METHADONE, SIMVASTATIN AND SERTRALINE
• Patient Outcome(s): Other
• Patient Age: 54 YR