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); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem Great Vessel Perforation (2152)

Event Date 09/27/2012

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot met all release criteria.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 a contraindication to anticoagulation, therefore, vena cava filter placement was indicated as a prophylactic measure.Using standard micropuncture technique, access was gained to the right common femoral vein.A venacavagram was performed and the ivc measured about 18 mm in diameter.The filter was deployed at the level of l1 without incident.The patient tolerated the procedure well without complications.Approximately two years post filter deployment, imaging demonstrated the filter at the level of l2-l3 with a detached limb in the ivc unchanged in configuration from a previous examination.On subsequent diagnostic exams, the filter was seen tilted at the level of l2-l3 with a detached limb in the ivc and several limbs extending beyond the confines of the ivc wall.Per the medical records available for review, no references to removal of the filter or complications from the filter were found.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.A vena cava filter was successfully deployed.One year and eleven months post filter deployment, x-ray demonstrated the filter at the level of l2-l3 and what appeared to be a fractured limb compared to previous imaging.Two years post filter deployment, a ct scan identified one filter limb to be extending beyond the confines of the ivc wall.Approximately two years and one month post filter deployment, x-ray demonstrated the tip of the filter at the end plate of l2.Three days later ct identified tines of the filter to be projecting outside the wall of the vena cava.Approximately two years and two months post filter deployment, x-ray identified the filter to be tilted to the right.Based on the medical records, the investigation can be confirmed for filter migration, tilt, perforation of the ivc wall, and detachment of filter limb.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques - movement, migration or tilt of the filter are known complications of vena cava filters.- perforation or other acute or chronic damage of the ivc wall.- filter tilt.- filter malposition.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.(b)(4).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 four months post prophylactic vena cava filter deployment, imaging demonstrated caudal migration of the filter and a detached filter limb in the ivc.Approximately two years post filter deployment, imaging demonstrated a tilted filter with several 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 in the medical records received.

• 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: 6166337
• MDR Text Key: 62235853
• Report Number: 2020394-2016-01157
• 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

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: EC500F
• Device Lot Number: GFWB4360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2012
• 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: AMANTADINE, ATORVASTATIN, BUMEX, FIORICET; MORPHINE PUMP; OXYCODONE, REQUIP, FLOMAX; SINEMET, COREG, PLAVIX, GABAPENTIN
• Patient Age: 50 YR
• Patient Weight: 121