MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF310F

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Hematuria (2558)

Event Date 07/09/2017

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: a sample evaluation could not be performed as the device was not returned.Images and medical records were not provided.The investigation is inconclusive for perforation of the ivc wall as no objective evidence has been provided to confirm any alleged deficiency with the filter.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: 06/2012).

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 perforated the ivc.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced hematuria; however, the current status of the patient is unknown.

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 seven years and two months post filter deployment, computed tomography revealed small saddle embolus involving the right lower lobe without right heart strain.Approximately two months later, patient presented with chest pain.Subsequent computed tomography revealed pulmonary emboli in the left lower lobe.Approximately seven months later, computed tomography revealed inferior vena cava filter with prong protruding through inferior vena cava and one of the tines of the inferior vena cava filter contacts the right ureter, which could potentially cause hematuria.Approximately four months later, patient experienced abdominal pain.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.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: 06/2012 section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

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 perforated the inferior vena cava and into the ureter.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced hematuria; however, the current status of the patient is unknown.

• Brand Name: G2 FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8846788
• MDR Text Key: 152810700
• Report Number: 2020394-2019-02035
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: GFTD1734
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLONIDINE, DOCUSATE SODIUM, ELIQUIS, FAMOTIDINE; COUMADIN, ADAPALENE, AMLODIPINE, CALCIUM CARBONATE; FLUOXETINE, FUROSEMIDE, GABAPENTIN, HEPARIN; HYDROCODONE, KETOCONAZOLE, LEVEMIR, LEVETIRACETAM; LISINOPRIL, METFORMIN, METOPROLOL, OMEPRAZOLE; MULTIVITAMIN; PRAVASTATIN, PROMETHAZINE, TOPIRAMATE; XARELTO, PHENERGAN, VENTOLIN, NOVOLIN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 45 YR
• Patient Weight: 129