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

Catalog Number MD800F

Device Problem Difficult to Remove (1528)

Patient Problem Pulmonary Embolism (1498)

Event Date 11/09/2020

Event Type  Injury  

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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2014).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 a patient with motor vehicle crash and deep vein thrombosis.Approximately six years eight months and sixteen days post a filter deployment, patient had allegedly developed pulmonary embolism.It was further reported that the device was allegedly removed with difficulty.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six years and eight months post filter deployment, an x-ray lumbar spine was performed for back pain showed that the filter was overlying in the l2-l3 level just to the right of midline.On the same day, a computed tomography angiogram of chest showed that positive for small bilateral pulmonary emboli.Around one day later, a computed tomography of abdomen/pelvis showed that the filter was noted in place with a likely chronic thrombosis of the iliac femoral veins.On the same day, patient underwent fluoroscopic guidance for placement of thrombolysis catheters for thrombolysis.Around one day later, patient underwent fluoroscopic guidance for placement of thrombolysis catheters for thrombolysis.Around one day later, patient underwent mechanical thrombectomy of inferior vena cava and right iliac and femoropopliteal veins.Around one day later, a computed tomography of abdomen and pelvis showed that intrarenal filter was noted.Around one month later, through the right internal jugular vein approach, a cavogram was performed which demonstrated a patent common iliac veins and inferior vena cava.There was an infrarenal retrievable type inferior vena cava filter in position.There were some filling defects around the apex of the filter likely representing fibrous material, presumably embedded within the wall of the inferior vena cava.Strut penetration through the inferior vena cava wall was also noted.The tip of the sheath was advanced to the apex of the filter and attempted to remove the filter with rigid endobronchial forceps.The forceps were advanced through the sheath under fluoroscopy.We tried chewing gauge the apex of the filter, but this proved difficult due to the filter apex position relative to the sheath position.Then we advanced the loop gooseneck snare and attempted to capture the hook of the filter.We were unable to do this likely due to the apex of the filter embedded into the wall of the inferior vena cava.At this point we were able to reengage the apex of the filter with endobronchial forceps and retrieved it from the body.Upon retrieval we did notice fracture of one of the legs of the filter.We removed the filter from the vascular sheath.We removed the pigtail catheter from the body, advanced a vascular sheath just cephalad to the fractured strut and then used the endobronchial forceps to remove the fractured component.We removed the fractured component from the body and inspected on the back table.Therefore, the investigation is confirmed for the reported retrieval difficulty, filter strut perforation and filter strut detachment.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 06/2014), g3, h6 (device, method).H11: b2, h6 (result, 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 an inferior vena cava filter was placed in a patient with motor vehicle crash and deep vein thrombosis.Six years, eight months and sixteen days post filter deployment, the patient experienced pulmonary embolism.It was further reported that filter strut had allegedly penetrated through the inferior vena cava wall.Furthermore, one of the legs of the filter was alleged found to be fractured during removal and the filter was removed with difficulty.The current status of the patient is unknown.

• Brand Name: MERIDIAN FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18637236
• MDR Text Key: 334494148
• Report Number: 2020394-2024-00152
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112497
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800F
• Device Lot Number: GFXE2960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2024
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female