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); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Abdominal Pain (1685)
Type of Reportable Event	Serious Injury
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.Bard simon nitinol filter was deployed in the inferior vena cava via the femoral route below the renal veins.Filter was within the inferior vena cava and there was no obvious extravasation of contrast.The filter was above the confluence and below the right renal vein.The device was deployed without difficulty, and the inferior vena cavogram confirmed appropriate positioning of the filter.Approximately eight years and ten months of post deployment, the patient had upper abdominal pain and a computed tomography of the abdomen and pelvis was performed.The images displayed migration of the filter, and up to 8 millimeters perforation to the right psoas muscle.The filter tilted with the apex of the filter perforating through the inferior vena cava wall to the mesentery.No fracture or stenosis was noted.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter tilt and filter migration.However the investigation is inconclusive for filter limb detachment since the medical records allege that "no fracture or stenosis was noted".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: 12/2012).
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 struts detached and retained in lungs.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: 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: 12323702
• Report Number: 2020394-2021-80702
• Device Sequence Number: 2696171
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K970099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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: GFTK3496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/16/2021
• 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: ATENOLOL, LISINOPRIL, GLUCOPHAGE; CLARITIN, PRILOSEC, AND RISPERDAL; GLYBURIDE, ZOLPIDEM, GABAPENTIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR