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

Catalog Number RF048F

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/27/2021

Event Type  Injury  

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after in conjunction motor vehicle accident.Approximately seventeen years six months and eleven days, post filter deployment, a computed tomography revealed that the inferior vena cava filter allegedly detached, and pieces of the detached filter had embolized and penetrated the inferior vena cava.It was further reported that the detached struts migrated to into the right ventricle of the heart and both lungs.Reportedly, the device was removed successfully, however the detached strut has not been removed and still retained inside patient body.The current status of the patent is unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after in conjunction motor vehicle accident.Approximately seventeen years six months and eleven days, post filter deployment, a computed tomography revealed that the inferior vena cava filter allegedly detached, and pieces of the detached filter had embolized and penetrated the inferior vena cava.It was further reported that the detached struts migrated to into the right ventricle of the heart and both lungs.Reportedly, the device was removed successfully, however the detached strut has not been removed and still retained inside patient body.The current status of the patent is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged filter limb detachment as no objective evidence has been provided to confirm any alleged deficiency with the filter.A definitive root cause for the filter limb detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: 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.H3 other text : device not returned.

• Brand Name: RECOVERY 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16900673
• MDR Text Key: 314887260
• Report Number: 2020394-2023-00323
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

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: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/14/2023
• 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): Required Intervention
• Patient Sex: Male