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 Death (1802)

Event Date 01/17/2018

Event Type  Death  

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.Approximately five years and eight months post deployment, computed tomography (ct) scan revealed that the ivc filter struts have penetrated through the ivc wall into the pericaval/mesenteric fat.Therefore, the investigation is confirmed for the peroration of the 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: 01/2013).

Event Description

It was reported through the litigation process that the filter struts perforated the ivc wall and extending into the mesenteric fat.The current status of the patient is unknown.New information: 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 perforated into the organs.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.New information: it was reported through the litigation process that some time post vena cava filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

• 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: 10161148
• MDR Text Key: 195359087
• Report Number: 2020394-2020-03959
• 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: 06/17/2020

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: GFVL0156
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2012
• 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: FUROSEMIDE, METOPROLOL SUCCINATE, SPIRONOLACTONE; IPRATROPIUM, SERTRALINE, LORAZEPAM, METRONIDAZOLE; LACTULOSE, OMEPRAZOLE, HYDROCODONE-ACETAMINOPHEN; MICONAZOLE, NICOTINE, DICLOFENAC, AMLODIPINE; POTASSIUM CHLORIDE, SPIRONOLACTONE, VANCOMYCIN.; WARFARIN, FLUOXETINE, MULTIPLE VITAMIN
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 87