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

Catalog Number EC500F

Device Problems Extrusion (2934); Unintended Movement (3026)

Patient Problem Great Vessel Perforation (2152)

Event Date 07/16/2013

Event Type  malfunction  

Manufacturer Narrative

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.This is the only event reported to date for this lot number and failure mode.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: the patient presented with acute deep venous thrombosis of the right lower extremity and a contraindication to anticoagulation, therefore, vena cava filter placement was indicated.Using standard micropuncture technique, access was gained to the left common femoral vein.A venacavagram demonstrated a fully patent inferior vena cava with inflow of both renal veins at the mid l1 level.The filter was deployed with the proximal tip at the mid l1 level without incident.The patient tolerated the procedure well without complications.Approximately three years post filter deployment, a ct of the abdomen demonstrated two filter limbs extending into the right renal vein.No further work up was indicated at that time.Approximately four years three months post filter deployment, a ct of the abdomen and pelvis demonstrated several filter limbs extending beyond the confines of the ivc wall.There was no acute intraabdominal process.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Images were not provided.Medical records were provided and reviewed.The vena cava filter was successfully deployed.Three years post filter deployment, two filter limbs were identified to be extending into the right renal vein.Four years and three months post filter deployment, several filter limbs were demonstrated to be extending beyond the ivc wall.Based on the provided medical records, the investigation can be confirmed for unintended movement and perforation of the ivc.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: - do not deploy the filter prior to proper positioning in the ivc, as the eclipse filter cannot be safely reloaded into the storage tube.Do not deploy the filter unless ivc has been properly measured.Never re-deploy a removed filter.- movement, migration or tilt are known complications of vena cava filters.Migration of filters to the heart or lungs has been reported.There have also been reports of caudal migration.Migration may be caused by placement of the filter in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.Precautions: - position the filter snare hook 1cm below the lowest renal vein.Venacavography must always be performed to confirm proper implant site.Radiographs without contrast, which do not clearly show the wall of the ivc, may be misleading.- if misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter.Potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.Direction for use: - implantation: - select the optimum location (for example 1cm below the lowest renal) for filter placement and measure the ivc diameter.- prior to deployment, verify the location of the filter within the sheath using fluoroscopy and confirm that the filter snare hook is 1cm below the lowest renal or is in the intended location in the inferior vena cava.The information provided by bard 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 bard.

Event Description

It was reported that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided.No alleged deficiency with the device was reported.No other information regarding this event was provided.The patient status at this time is unknown.New information received: medical records were received and reviewed.Approximately three years post vena cava filter deployment indicated for a contraindication to anticoagulation, a ct scan demonstrated two filter limbs extending into the right renal vein.Approximately four years three months post filter deployment, a ct scan demonstrated several filter limbs extending beyond the confines of the ivc wall.There was no known impact or consequence to the patient.No additional information surrounding this event was provided.

• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6166338
• MDR Text Key: 62235041
• Report Number: 2020394-2016-01158
• 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: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/28/2016

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: 07/31/2013
• Device Catalogue Number: EC500F
• Device Lot Number: GFUE4456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2010
• 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: DUONEB INHALER, PHENERGAN; FENTANYL PATCH, NEURONTIN, PROTONIX, PROZAC; METOPROLOL, POTASSIUM, TRAZODONE,CLONAZEPAM; SYNTHROID, ZOCOR, AMBIEN, DILAUDID, PERCOCET; VITAMIN D, CENTRUM SILVER, COLACE, DIOVAN, TYLENOL
• Patient Age: 58 YR