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

Catalog Number EC500F

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 08/22/2016

Event Type  Injury  

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one year post filter deployment, patient presented with chest pain.Subsequent, ct revealed no evidence of pulmonary embolism.Approximately two years later, ct revealed ivc filter in place and one of the spokes of the ivc filter protrudes into the right iliopsoas and also one of the spokes of the ivc filter protrudes into the right renal vein.Therefore, the investigation is confirmed for perforation of the ivc.However, the investigation is inconclusive for filter migration and filter limb detachment.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.(expiry date:04/2016).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient due to gunshot wound.At some time post filter deployment, it was alleged that the filter detached, migrated to the heart, and struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.It was further reported that the detached struts retained in abdomen.The current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• 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: 9471873
• MDR Text Key: 174554152
• Report Number: 2020394-2019-05628
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: GFXC3602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• 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: 24 YR
• Patient Weight: 73