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

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2012

Event Type  malfunction  

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 four months later post filter deployment, the patient scheduled for the filter retrieval, the right internal jugular vein was accessed.An inferior vena cavogram was performed, the pertinent findings was angulation of the inferior vena cava just below the renal veins, presumably near the origin of the right renal vein.Initial maneuvers at grasping the apex with a 2cm snare failed.The 2cm snare was replace with 1.5cm snare and additional maneuvers were failed.It was felt the angulation of the inferior vena cava combined with location of the filter apex was adverse in terms of retrieval.The benston wire was snared below the filter.Next, the hoop was created by snare benston wire was tightened against the collar of the filter and the snared was then pulled cephalad with the 18-french advanced caudad.Unfortunately, even with the snare there was tilt of the filter apex hook outside the sheath.At this juncture, there appeared to be more tilt of the filter.Clearly displaced filter legs from the manipulation.Multiple attempts were made without success.It was felt retrieval was not possible and the procedure was then aborted.Therefore, the investigation is confirmed for the alleged filter tilt, material deformation and retrieval difficulties 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.(expiry date: 02/2015).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient due to blood clots.At some time post filter deployment, the filter was unable to be retrieved.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient was unknown.

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 four months later post filter deployment, the patient scheduled for the filter retrieval, the right internal jugular vein was accessed.An inferior vena cavogram was performed, the pertinent findings was angulation of the inferior vena cava just below the renal veins, presumably near the origin of the right renal vein.Initial maneuvers at grasping the apex with a 2cm snare failed.The 2cm snare was replace with 1.5cm snare and additional maneuvers were failed.It was felt the angulation of the inferior vena cava combined with location of the filter apex was adverse in terms of retrieval.The benston wire was snared below the filter.Next, the hoop was created by snare benston wire was tightened against the collar of the filter and the snared was then pulled cephalad with the 18-french advanced caudad.Unfortunately, even with the snare there was tilt of the filter apex hook outside the sheath.At this juncture, there appeared to be more tilt of the filter.Clearly displaced filter legs from the manipulation.Multiple attempts were made without success.It was felt retrieval was not possible and the procedure was then aborted.Therefore, the investigation is confirmed for the alleged filter tilt, material deformation and retrieval difficulties 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.(expiry date: 02/2015).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient due to blood clots.At some time post filter deployment, the filter was unable to be retrieved.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient was 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: 13556744
• MDR Text Key: 285826631
• Report Number: 2020394-2022-90090
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2022

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 Catalogue Number: EC500F
• Device Lot Number: GFWA4234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/18/2022
• 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
• Treatment: IPRATROPIUM-ALBUTEROL; WARFARIN, VERAPAMIL, ATROVENT HFA
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 73 KG