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

Catalog Number MD800F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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.Around three years and seven months later, computed tomography of the abdomen was performed due to abdominal pain, and results revealed that an inferior vena cava filter was in place at the level of the right renal vein in appropriate orientation without fracture or displacement.Multiple inferior vena cava struts extended beyond the wall of the inferior vena cava.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).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.(expiry date: 05/2014).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with back surgery and motor vehicle accident.Approximately three years and seven months post filter deployment, a computed tomography (ct) revealed that the filter struts perforated and the patient reportedly experienced abdominal pain.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 - 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: 10558893
• MDR Text Key: 207697441
• Report Number: 2020394-2020-05713
• 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: 09/21/2020

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: GFXD3845
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2013
• 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: ANTIVERT, BENAZEPRIL, DOCUSATE SODIUM, EFFEXOR.; COUMADIN, LOVENOX, PRILOSEC, ACETAMINOPHEN.; ENEMEEZ PLUS, FUROSEMIDE, GABAPENTIN.; FERROUS SULFATE, KEFLEX, NEURONTIN.; LODOSORB, LACTULOSE, METFORMIN, NORCO, OMEPRAZOLE.; SENNA, SIMVASTATIN, AMITRIPTYLINE.; TRAZODONE, VICODIN, ZANTAC AND LIPITOR.
• Patient Outcome(s): Other
• Patient Age: 61 YR