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

Catalog Number RF048F

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.After sometimes post deployment, lumbar x-ray showed inferior vena cava filter strut fracture.L-spine series showed recovery filter with one arm in filter, one missing.There was a recovery filter in place with two arms fractured, one in the right middle lobe and the other trapped in the filter.There was a thin linear metallic object measuring approximately 2 cm in length which was in keeping with the known embolized inferior vena cava arm which was in the region of the right middle lobe as seen on the lateral radiograph.After five months, the patient with consultation regarding fractured embolized recovery inferior vena cava filter for possible removal.After one-month, complex inferior vena cava filter removal was scheduled.Access was gained via right internal jugular vein.Multiple spot images of the filter were performed.The filter was then dissected free of the wall of the inferior vena cava using endobronchial forceps in the jaws of life technique.It was removed successfully.Then, the fractured strut within the infrarenal inferior vena cava was removed using endobronchial forceps in the jaws of life technique.Post removal cavogram was performed.Next, selective right pulmonary arteriography was performed.Super selective catheterization of the right middle lobe pulmonary artery containing the fragment was performed and further diagnostic arteriography carried out.Looking 3 white set, the embolized filter fragment was removed using a snare.Successfully complex filter removed using jaws of life technique.Successful removal of locally retained fragment.Successful removal of embolized fragment to right pulmonary artery.Cross description stated that the case was received in one container, labeled with the patient's name and medical record number.Specimen 1 was without additional designation and consists of a 4.4 x 2.6 x 2 cm blue metal wire device with one open end, which was comprised of 6 legs each measuring 3.8 cm in length (5 with hooked ends, one without) and 4 bent arms each measuring 2.3 cm in length.Also present separately in the specimen container were 2 pieces measuring 2.0 and 2.3 cm in length and 0.1 cm diameter.Therefore, the investigation is confirmed for the alleged filter detachment and material deformation.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.Device not returned.

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 struts were bent and detached.The device along with detached struts were removed percutaneously.The current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• 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: 12655804
• MDR Text Key: 277127201
• Report Number: 2020394-2021-01886
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• 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: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/19/2021
• 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: ALLOPURINOL, ASPIRIN, ATORVASTATIN; AMOXICILLIN, COLCHICINE, TOPIRAMATE; B COMPLEX VITAMINS, CELECOXIB, CHOLECALCIFEROL; DULOXETINE, AND ROSUVASTATIN; GABAPENTIN, HYDROCHLOROTHIAZIDE, MORPHINE; OMEPRAZOLE, OXYCODONE, OXYCODONE-ACETAMINOPHEN; SENNA, TRAZODONE, WARFARIN, LOVENOX
• Patient Age: 60 YR
• Patient Weight: 105