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

Catalog Number 2120F

Device Problems Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem Pain (1994)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The investigation of the reported event is currently underway.The information provided by bard 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 bard.

Event Description

It was reported that during deployment of a vena cava filter via the right femoral, the filter allegedly did not fully open and another filter was deployed.It was further reported that approximately 15 years post deployment of a vena cava filter, the patient started experiencing severe pain and discomfort and consulted with her physician.Approximately one year later, the patient requested an x-ray as the pain was no longer tolerable.Initial evaluation of the x-ray did not find any issues with the filter.A secondary physician consult identified the filter as broken into pieces.Location of the filter was not specified.Medical intervention was not necessary.The filter remains implanted.The patient was reportedly experiencing pain and discomfort.

Manufacturer Narrative

Manufacturing review: the device lot number was not provided; therefore, a manufacturing review was not performed.Visual inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was not returned.Images and medical records were not provided.The investigation was inconclusive for filter detachment or failure of the filter to expand on deployment.Based on the available information, the definitive root cause for this event was unknown.Labeling review: the current ifu (instructions for use) states: filter release/deployment: note: the dome of the filter will normally descend 1-2cm during shape recovery so that its tip will be lower than its actual position in the introducer before unsheathing.If the vena cava is too small to accommodate the fully centered filter dome, the dome may tilt toward the vena cava wall, or assume a spindle or cone configuration.These variations are functionally effective in undersized lumens.

Event Description

It was reported that during deployment of a vena cava filter via the right femoral, the filter allegedly did not fully open and another filter was deployed.It was further reported that approximately 15 years post deployment of a vena cava filter, the patient started experiencing severe pain and discomfort and consulted with her physician.Approximately one year later, the patient requested an x-ray as the pain was no longer tolerable.Initial evaluation of the x-ray did not find any issues with the filter.A secondary physician consult identified the filter as broken into pieces.Location of the filter was not specified.Medical intervention was not necessary.The filter remains implanted.The patient was reportedly experiencing pain and discomfort.

• Brand Name: SIMON NITINOL FILTER SYSTEM
• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6138938
• MDR Text Key: 61244984
• Report Number: 2020394-2016-01127
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

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: 2120F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other