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

Model Number	2120F
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Inflammation (1932)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2011).
Event or Problem 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 tilted and struts perforated the vena cava wall and to the mesentery.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient had inflammation around the filter.The current status of the patient is unknown.
Event or Problem 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 tilted and struts perforated the vena cava wall and to the mesentery.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient had inflammation around the filter.The current status of the patient is unknown.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one week later, computed tomography revealed a vena cava filter.Approximately five years and nine months later, the patient presented with abdominal pain.Approximately three years and six months later, computed tomography revealed inferior vena cava filter was in place below the level of the renal veins.There was no measurable tilting of the device.However, the proximal end was bent posteriorly by 35 degrees.The distal anchoring struts extended beyond the vessel wall.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.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: 01/2011.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.

• Brand Name: SIMON NITINOL FILTER SYSTEM
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11632628
• Report Number: 2020394-2021-80268
• Device Sequence Number: 3196760
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: GFRL1898
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CEPHALEXIN, NORVASC AND FUROSEMIDE; CEPHALEXIN, NORVASC AND FUROSEMIDE; HYDROCHLOROTHIAZIDE, NORCO, PROTONIX AND ULTRACET; HYDROCHLOROTHIAZIDE, NORCO, PROTONIX AND ULTRACET; LORTAB, COUMADIN, ALPRAZOLAM AND CARVEDILOL; LORTAB, COUMADIN, ALPRAZOLAM AND CARVEDILOL; CEPHALEXIN, NORVASC AND FUROSEMIDE; HYDROCHLOROTHIAZIDE, NORCO, PROTONIX AND ULTRACET; LORTAB, COUMADIN, ALPRAZOLAM AND CARVEDILOL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Weight: 73