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

Catalog Number MD800F

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2018

Event Type  Injury  

Event Description

It was reported through the litigation process that a vena cava filter was placed through the right femoral vein approach, in a patient with lower extremity deep vein thrombosis.It was further reported that five years, ten months and four days post a filter deployment, the filter was allegedly difficult to remove.Reportedly, the device has been removed and one of the fractured strut allegedly remained in the patient.The current status of the patient was 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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2012) 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed through the right femoral vein approach, in a patient after being diagnosed with lower extremity deep vein thrombosis.It was further reported that five years, ten months and four days post a filter deployment, it was alleged that the filter strut had detached and the filter was allegedly difficult to remove.Reportedly, the device has been removed and one of the the fractured strut allegedly remained in the patient.The current status of the patient is unknown.

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 five years and ten months post filter deployment, patient was planned for filter retrieval procedure.Through the right internal jugular vein approach, a sheath was inserted and then performed vena cavogram which demonstrated no evidence of any thrombus in the inferior vena cava or filter.Inserted the bard denali retrieval device and unable to snare the filter.At this point, up sized to 16 french cook sheath over the stiff wire and unable to snare the filter.I inserted a curved catheter and was able to snare the glide wire, pulled it through the 16 french sheath.At this point, we had the wire around the filter and then advanced the sheath and retrieved the filter.The filter was pretty adherent to the wall, scarred to the wall of the inferior vena cava.The filter was removed without any difficulty.Upon exiting, noted the one leg of the filter was so scarred down and stuck in the vena cava wall, and it could not be retrieved.Therefore, the investigation is confirmed for the reported difficult to remove and filter leg detachment.Additionally, device fragments in body is confirmed because one fractured leg is stuck in the vena cava wall and cannot be removed.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 (expiration date: 11/2012), g3, h6 (device, method).H11: section a through f ¿ the information provided by bd represents all 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.

• 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: 18500705
• MDR Text Key: 332724256
• Report Number: 2020394-2023-01387
• 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,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: GFVJ2447
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female