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); Patient Device Interaction Problem (4001)

Patient Problem Death (1802)

Event Type  Death  

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.Approximately thirteen years and one-month post filter deployment, the patient evaluated the filter while they are experiencing back pain.In patient history, computed tomography (ct) revealed the filter was already partially protruding outside the inferior vena cava.After one month later, computed tomography (ct) revealed the tip of the inferior vena cava filter was seen inferior to the right renal vein and the limbs of the filter extend outside the wall of the inferior vena cava to the surrounding fat.The inferior aspect of the inferior vena cava filter was seen almost at the level of bifurcation.The inferior vena cava filter had punctured and moved.After one month and seven days later, the patient scheduled for filter retrieval.A 12 french cook filter retrieval sheath that was advanced over an amplatz wire just above the inferior vena cava filter.Various attempts to place the snare over the tip of the filter was failed due to the left lateral position of the filter.10 x 40 mm dorado balloon on the left side of the filter over a wire and push it slightly towards the middle of the inferior vena cava to grasp the filter with snare and it could not get into the coaxial sheath retrieval system.By repositioning the balloon from the groin was finally able to align the filter and get it into the sheath.At this stage, it started to constrict the filter however it was attached firmly to the right wall of the inferior vena cava.Therefore, the procedure was stopped.The completion cavagram demonstrated good flow through the inferior vena cava without thrombosis.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and retrieval difficulties.However, the investigation is inconclusive for filter migration.Based on 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter struts perforated.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The patient reportedly expired.

• 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: 10182797
• MDR Text Key: 196045782
• Report Number: 2020394-2020-04025
• 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: 06/23/2020

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: GFOE0993
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/23/2020
• 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): Death