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

Catalog Number RF048F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eleven years and eleven months later, the patient presented for filter removal.Real-time ultrasound guidance was used to puncture the right internal jugular vein and the tract was dilated.A 16 fr sheath was placed.The filter was presented with two fractured fragments.Intravascular fractured limb was removed, unsuccessful removal of extravascular limb and the filter body was removed by using endobronchial forceps in the jaws of life technique.Post cavogram demonstrates no thrombus in the inferior vena cava.Therefore, the investigation is confirmed for alleged filter limb detachment.However, the investigation is inconclusive for alleged perforation of the inferior vena cava (ivc), filter migration, and retrieval difficulties.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.(device: (b)(4)).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.Approximately eleven years and eleven months post filter deployment, it was alleged that the entire filter migrated to heart, struts detached and perforated into organs.The device was removed percutaneously after an attempted but unsuccessful percutaneous removal procedure.Reportedly the detached strut retained in extravascular to the inferior vena cava.The current status of the patient is unknown.

• 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 NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10974841
• MDR Text Key: 220420444
• Report Number: 2020394-2020-06485
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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
• Date Manufacturer Received: 11/12/2020
• 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
• Patient Age: 52 YR