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

Catalog Number MD800F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately two years and one-month post filter deployment, the patient experienced abdominal pain and a left lower extremity pain.On the same day, computed tomography performed revealed inferior vena cava filter was in place.After ten months and six days later, computed tomography revealed the superior extent of inferior vena cava filter was at mid l2 vertebral body and inferior extent at inferior l3 vertebral body, positioned within 1 cm of the renal veins.A total of 6 prongs had perforated the inferior vena cava.Maximum distance prongs perforated was 2 mm.This was most significant, where the tine abutted the surface of the infrarenal abdominal aortic aneurysm.Coronal images showed 1-degree tilt right-to-left and sagittal images showed 4-degrees tilt anterior to posterior.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is unconfirmed for filter tilt as the medical records state ¿coronal images showed 1-degree tilt right-to-left and sagittal images showed 4-degrees tilt anterior to posterior.¿ based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with unknown medical complication.At some time post filter deployment, it was alleged that the filter tilted and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, 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 AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11364069
• MDR Text Key: 233013265
• Report Number: 2020394-2021-80184
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/23/2021
• 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: ALPRAZOLAM, PROSCAR, FUROSEMIDE AND PLAVIX; PREDNISONE, PHENERGAN, LISINOPRIL AND PROTONIX; TAMSULOSIN, ASPIRIN, MUCINEX AND ONDANSETRON; ZITHROMAX AND NORCO
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 68