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

Catalog Number UNK MERIDIAN

Device Problem Material Deformation (2976)

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

Event Date 11/02/2017

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, computerized tomography-abdomen without contrast showed 2 inferior vena cava filters were noted.Upper filter appears to be positioned with the apex adjacent to the anterior wall of the inferior vena cava.Apex was above the renal veins by approximately 3.4 cm above the upper margin of the left renal vein and 2.8 cm above the upper margin of the right upper renal vein.Struts were intact.Two struts on the right extending into the right upper renal vein.After six months, computerized tomography chest/abdomen/pelvis performed for evaluation of the lung windows which demonstrated no evidence for infiltrate, pleural effusion or pneumothorax.No suspicious pulmonary nodules were identified.Linear atelectasis or scarring in the left lower lobe was present.There was linear hyper density within a right lower lobe pulmonary arterial branch as visualized on images 28 through 31 of series 7 which was suspected to result from a metallic limb embolus arising from the suprarenal inferior vena cava filter.A limb arising from the suprarenal inferior vena cava filter appears extraluminal, located within the right kidney.The more cephalad, suprarenal inferior vena cava filter has an abnormal morphology.A less than arising from this filter extends extraluminal to the inferior vena cava and was likely located within the kidney.Additionally, there was a second limb which appeared to have embolized into the right lower lobe.Therefore, the investigation is confirmed for the alleged 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 deployed successfully, the reason for the filter deployment was not provided.At some time post filter deployment, it was alleged that filter had material deformation.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: MERIDIAN 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: 12655168
• MDR Text Key: 277135314
• Report Number: 2020394-2021-01885
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 10/04/2021

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: UNK MERIDIAN
• 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: HYDROCHLOROTHIAZIDE, IBUPROFEN, MAGNESIUM SULFATE; HYDROMORPHONE, ACETAMINOPHEN, GABAPENTIN; METFORMIN, AND VITAMIN D2; METOCLOPRAMIDE, ONDANSETRON, PANTOPRAZOLE
• Patient Age: 39 YR
• Patient Weight: 147