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

Model Number	2120F
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abdominal Pain (1685)
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: 06/2013).
Event or Problem Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that the filter perforated beyond the inferior vena cava wall.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain, however; 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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Bard permanent simon nitinol inferior vena cava filter was implanted below the renal veins for patient as a prophylaxis for a total right knee replacement.Completion imaging demonstrated normal deployment and good positioning of filter.Approximately eight years and eight months post filter deployment, computed tomography (ct) revealed that there was an inferior vena cava filter in place, the tip of which was just above the level of the right renal vein.The cephalic aspect of the filter appeared to lay outside of the confines of the vena cava anteriorly.Several of the filter limbs have pierced the inferior vena cava.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter migration.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.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 or Problem Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that the filter perforated beyond the inferior vena cava wall.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain, however; 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: 11656084
• Report Number: 2020394-2021-80292
• Device Sequence Number: 14299880
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: GFUE3452
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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: FRAGMIN, SENOKOT, FEOSOL, PROTONIX; FRAGMIN, SENOKOT, FEOSOL, PROTONIX; HYDROCHLOROTHIAZIDE, VANCOMYCIN, CALCIUM CARBONATE; HYDROCHLOROTHIAZIDE, VANCOMYCIN, CALCIUM CARBONATE; MELOXICAM, LORAZEPAM, LISINOPRIL, ZOFRAN; MELOXICAM, LORAZEPAM, LISINOPRIL, ZOFRAN; PERCOCET, RESTORIL, AMBIEN, AND COMPAZINE; PERCOCET, RESTORIL, AMBIEN, AND COMPAZINE; TYLENOL, MAALOX, BENADRYL, NARCAN; TYLENOL, MAALOX, BENADRYL, NARCAN; FRAGMIN, SENOKOT, FEOSOL, PROTONIX; HYDROCHLOROTHIAZIDE, VANCOMYCIN, CALCIUM CARBONATE; MELOXICAM, LORAZEPAM, LISINOPRIL, ZOFRAN; PERCOCET, RESTORIL, AMBIEN, AND COMPAZINE; TYLENOL, MAALOX, BENADRYL, NARCAN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 116