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

Catalog Number UNK ECLIPSE

Device Problem Obstruction of Flow (2423)

Patient Problems Edema (1820); Pain (1994); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review 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.Journal article citation: desai, k.R., xiao, n., karp, j., salem, r., rodriguez, h., eskandari, m., ¿ lewandowski, r.J.(2019).Single-session inferior vena cava filter removal, recanalization, and endovenous reconstruction for chronic iliocaval thrombosis.Journal of vascular surgery: venous and lymphatic disorders, 7(2), 176¿183.Doi: 10.1016/j.Jvsv.2018.10.014.

Event Description

It was reported in an article from the journal of vascular surgery titled " single-session inferior vena cava filter removal, recanalization, and endovenous reconstruction for chronic iliocaval thrombosis " that one patient presented with inferior vena cava filter (ivcf) related chronic iliocaval thrombosis resulting in severe venous stasis symptoms underwent single-session filter retrieval, followed by recanalization with stent placement and adjunctive iliofemoral thrombectomy as needed.Technical success was achieved after the procedure.

• Brand Name: ECLIPSE FILTER
• 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: 9513330
• MDR Text Key: 174564435
• Report Number: 2020394-2019-05744
• 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: health professional,literatur
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ECLIPSE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• 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): Required Intervention