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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Great Vessel Perforation (2152); No Consequences Or Impact To Patient (2199)
Event Date 05/15/2012
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 with history of hypercoagulable state, left acetabular fracture, left open knee joint and morbid obesity was scheduled for vena cava filter placement. The right common femoral vein was accessed and intravascular ultrasound (ivus) was used to identify the renal veins. The filter was deployed and ivus was used to confirm excellent infrarenal position. The catheter and guidewire were removed and pressure was held for approximately 5 minutes. The patient tolerated the procedure well. Approximately six months post filter deployment the patient was scheduled for filter retrieval. The internal jugular vein was accessed and inferior venacavography demonstrated a somewhat constricted ivc filter at the level of l3. This was related to an occlusion of the inferior vena cava in the lower portion of the filter extending caudally. Limited attempts to remove the filter were unsuccessful due to embedding of the filter into the wall of the cava preventing engagement of the apical hook. Image/photo review: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned for evaluation and images were not provided for review. However, medical records were provided and reviewed. Approximately six months post filter deployment during a schedule filter retrieval procedure, an inferior venacavography demonstrated a somewhat constricted ivc filter at the level of l3. This was related to an occlusion of the inferior vena cava in the lower portion of the filter extending caudally. Limited attempts to remove the filter were unsuccessful due to embedding of the filter into the wall of the cava preventing engagement of the apical hook. Therefore, based on the provided medical records the investigation can be confirmed for the occlusion of the ivc filter and difficulties removing the filter. The investigation is inconclusive for the alleged tilted filter and perforation of the ivc wall. 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. Do not attempt to remove the denali filter if significant amount of thrombus are trapped within the filter or if the filter snare hook is embedded within the vena cava w. 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. Potential complications: 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 malposition filter tilt. Caval thrombosis/occlusion. Occlusion of small vessels. (b)(4).
 
Event Description
It was reported a vena cava filter was deployed in conjunction with a trauma situation/motor vehicle accident. After an unknown amount of time post filter deployment, allegedly the filter strut(s) perforated into organs, tilted and embedded in the wall of the ivc, and was unable to be retrieved after an attempted but unsuccessful percutaneous removal procedure. Based on review of the medical records received, approximately six months post filter deployment, during a retrieval procedure, an inferior venacavogram demonstrated occlusion of the inferior vena cava in the lower portion of the filter extending caudally. Limited attempts to retrieve the filter were unsuccessful due to embedding of the filter into the caval wall. No additional information was provided in the medical records received.
 
Manufacturer Narrative
No medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Medical record review: the patient with history of hypercoagulable state, left acetabular fracture, left open knee joint and morbid obesity was scheduled for vena cava filter placement. The right common femoral vein was accessed and intravascular ultrasound (ivus) was used to identify the renal veins. The filter was deployed and ivus was used to confirm excellent infrarenal position. The catheter and guidewire were removed and pressure was held for approximately 5 minutes. The patient tolerated the procedure well. Approximately six months post filter deployment the patient was scheduled for filter retrieval. The internal jugular vein was accessed and inferior venacavography demonstrated a somewhat constricted ivc filter at the level of l3. This was related to an occlusion of the inferior vena cava in the lower portion of the filter extending caudally. Limited attempts to remove the filter were unsuccessful due to embedding of the filter into the wall of the cava preventing engagement of the apical hook. 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 a vena cava filter was deployed in conjunction with a trauma situation/motor vehicle accident. After an unknown amount of time post filter deployment, allegedly the filter strut(s) perforated into organs, tilted and embedded in the wall of the ivc, and was unable to be retrieved after an attempted but unsuccessful percutaneous removal procedure. Based on review of the medical records received, approximately six months post filter deployment, during a retrieval procedure, an inferior venacavogram demonstrated occlusion of the inferior vena cava in the lower portion of the filter extending caudally. Limited attempts to retrieve the filter were unsuccessful due to embedding of the filter into the caval wall. No additional information was provided in the medical records received.
 
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Brand NameECLIPSE FILTER SYSTEM - FEMORAL
Type of DeviceVENA 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 Key6666933
MDR Text Key196476224
Report Number2020394-2017-00706
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2014
Device Catalogue NumberEC500F
Device Lot NumberGFVH1916
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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