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

Catalog Number RF310F

Device Problems Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

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

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged filter tilt, filter limb detachment, perforation of the inferior vena cava (ivc) and occlusion as no objective evidence has been provided to confirm any alleged deficiency with the filter.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported through the litigation process that a vena cava filter was placed in conjunction with trauma situation/motor vehicle accident.Approximately twelve years and two months post filter deployment, angiojet thrombectomy revealed that the filter tilted, occluded, two of the struts detached and perforated the right psoas muscle and right iliac artery.The device was removed by complex removal procedure using dual access via the right jugular and right groin; however, the detached struts remained in the body.The patient reportedly experienced abdominal pain.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that a vena cava filter was placed in conjunction with trauma situation/motor vehicle accident.Approximately twelve years and two months post filter deployment, angiojet thrombectomy revealed that the filter tilted, occluded, two of the struts detached and perforated the right psoas muscle and right iliac artery.The device was removed by complex removal procedure using dual access via the right jugular and right groin; however, the detached struts remained in the body.The patient reportedly experienced abdominal pain.The current status of the patient is unknown.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.H10: b2, d4 (expiry date: 09/2010).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.H3 other text : device not returned.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and 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.Medical records were provided and reviewed.Approximately twelve years and two months later, a computed tomography of abdomen and pelvis was performed which showed filter was slightly tilted anteriorly and laterally prior to retrieval and the filter apex was in direct contact with the anterior caval wall, where it was likely partially embedded.At least two strut fractures were present prior to retrieval.Neither could be removed and one penetrates into the adjacent aorta and additionally two of the terminal filter leg anchoring hooks were also noted to be fractured and detached from the filter.Neither of these fractured filter components could be removed.Multiple struts and arms perforated the patient¿s inferior vena cava.Perforating struts penetrated right psoas muscle and into the overlying right iliac artery.Caval thrombosis/stenosis was also identified, and extensive venous collateralization was present.Ileofemoral thrombosis extending up to and involving the filter.The inferior vena cava appeared chronically occluded, most likely secondary to the inferior vena cava filter.On the next day, patient underwent placement of thrombolysis catheter.Initial venography showed extensive clot extending from the common femoral vein to common iliac vein.Complete, chronic occlusion at the inferior vena cava confluence.Clot burden within the distal right lower extremity posterior tibial vein, popliteal and superficial femoral vein have resolved with heparin infusion overnight.Angiojet thrombectomy was performed to the right iliac veins.On the next day, patient was planned for filter retrieval procedure.Initial venography study confirmed complete occlusion of the iliocaval confluence with extensive venous collaterals.There are two broken shards that remain but were already displaced outside of the inferior vena cava.The inferior vena cava filter was retrieved using endobronchial forceps from the right internal jugular vein access.There were two broken struts, one penetrating into adjacent aorta, could not be removed and remain in the patient¿s body.Therefore, the investigation is confirmed for the alleged filter tilt, perforation of the inferior vena cava, filter detachment and filter occlusion.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 09/2010), g3, h6(method).H11: h6(result and conclusion).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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that a vena cava filter was placed in conjunction with trauma situation/motor vehicle accident.Approximately twelve years and two months post filter deployment, angiojet thrombectomy revealed that the filter tilted, occluded, two of the struts detached and perforated the right psoas muscle and right iliac artery.The device was removed by complex removal procedure using dual access via the right jugular and right groin; however, the detached struts remained in the body.The patient reportedly experienced abdominal pain.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 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11736097
• MDR Text Key: 247669068
• Report Number: 2020394-2021-00927
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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: GFRH4267
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2007
• 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
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American