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

Catalog Number EC500F

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.During deployment of the filter, the pusher rod was difficult to release from the hook of the filter resulting in additional manipulation of the delivery device.Therefore, based on the provided medical records the investigation is confirmed for deployment difficulties.However, the investigation is inconclusive for the alleged tilt based on the provided information.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: - movement, migration or tilt of the filter are known complications of vena cava filters.Precautions: - do not deliver the filter by pushing it beyond the end of the introducer sheath.To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath.Do not twist the pusher wire handle at anytime during this procedure potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.- filter malposition - filter tilt.

Event Description

It was reported through the litigation process that a vena cava filter was deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some unknown amount of time post filter deployment, the patient alleged angulation of the filter.The filter was not removed and no retrieval attempts were made to remove the filter.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.During the deployment, the pusher rod was stuck to the filter which took manipulation to get the pusher rod off the filter without moving the filter.The patient tolerated the procedure well and there were no complications.Approximately four years post filter deployment, computed tomography revealed there was grade 3 perforation with posterior strut embedded l4 with 13 mm.Left lateral strut was abutting aorta with 4mm.Right posterior strut was abutting right psoas muscle with 2 mm.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and difficult to deploy.However, the investigation is inconclusive for filter tilt.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.H10: b6, b7, d4(expiry date: 11/2015).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.

Event Description

It was reported through the litigation process that a vena cava filter was deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, the patient alleged angulation of the filter.The filter was not removed and no retrieval attempts were made to remove the filter.There was no reported patient injury.

• 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
• MDR Report Key: 6950172
• MDR Text Key: 90303347
• Report Number: 2020394-2017-01342
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: EC500F
• Device Lot Number: GFWJ1326
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN-HYDROCODONE, AMLODIPINE; CHOLECALCIFEROL, CLOPIDOGREL, DIVALPROEX; ENOXAPARIN, EZETIMIBE, OMEPRAZOLE, SIMVASTATIN; TUBERCULIN PURIFIED PROTEIN DERIVATIVE
• Patient Age: 71 YR
• Patient Weight: 98