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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 Malposition of Device (2616); Detachment of Device or Device Component (2907); Extrusion (2934)
Patient Problem Great Vessel Perforation (2152)
Event Date 06/29/2015
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. 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: a vena cava filter was deployed for history of dvt, thrombus of the left peroneal vein, pulmonary emboli in the right lower lobe while on coumadin. A contrast injected vena cavagram demonstrated the renal takeoffs in the ivc. The filter was deployed inferior to the renal veins at the level of l1-l2 of the lumbar spine. The ivc was reported to be normal in size; filter was deployed in a good position. There was no reported patient injury. Approximately three years and eight months post filter deployment an abdominal x-ray demonstrated two detached filter limbs; although, a follow-up ct scan of the abdomen demonstrated 10 filter limbs attached to the filter located at the t3-t4 interspace, the location of the two detached filter limbs were not identified in the chest abdomen or pelvis. Approximately three years ten months post filter deployment an attempted filter retrieval procedure was performed. Fluoroscopy demonstrated a tilted filter with several filter limbs perforating the ivc wall. Despite multiple attempts made with a snare device and various other techniques used, the filter could not be retrieved. The filter apex was reported to be embedded in the ivc wall. There was no reported patient injury. A chest x-ray performed approximately four months later demonstrated a thin linear radiopaque foreign body overlying the posterior left 10th rib. A second filter retrieval attempt was made approximately four months post initial filter retrieval attempt; however, despite multiple attempts made with a snare and endobronchial forceps, the filter could not be retrieved. The procedure was terminated after two hours of unsuccessful attempts made to retrieve the filter. There was no reported patient injury. Seven days later the third attempt was made to retrieve the filter. Using a snare device the filter was successfully captured and retrieved without incident. A detached filter limb embedded in the ivc wall was also captured and retrieved. A final contrast injected vena cavagram did not demonstrate ivc extravasation, filling defects or any residual radiopaque foreign body in the ivc. The medical records received did not provide any additional information regarding the second detached filter limb, there is no information indicating an attempted retrieval was made for the second detached filter limb. Three weeks post successful filter retrieval another manufacturer's filter was successfully deployed inferior to the renal takeoffs. Image/photo review: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned. Images were not provided. Medical records were provided and reviewed. A vena cava filter was successfully deployed below the renal veins at the level of l1-l2. Approximately three years and eight months post filter deployment, x-ray demonstrated two detached filter limbs; although, a follow-up ct scan of the abdomen demonstrated 10 filter limbs attached to the filter located at the t3 - t4 interspace, the location of the two detached filter limbs were not identified in the chest abdomen or pelvis. Approximately three years and ten months post filter deployment an attempted filter retrieval was unsuccessful. Fluoroscopy demonstrated a tilted filter with several filter limbs perforating the ivc wall. A second filter retrieval attempt was made approximately four months post initial filter retrieval attempt; however, despite multiple attempts made with a snare and endobronchial forceps, the filter could not be retrieved. Based on the medical records, the investigation can be confirmed for filter migration, filter tilt, perforation of the ivc wall, filter limb detachment and difficulties removing the filter. 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: medical records received and reviewed. A vena cava filter was deployed inferior to the renal takeoffs for history of dvt and pe while on anticoagulated medication. Approximately four years post filter deployment imaging demonstrated filter migration, two detached filter limbs; one embedded in the ivc wall and second was identified overlying a rib. Over the next eight months three filter retrieval procedures were performed. The first two retrieval attempts were unsuccessful, despite multiple attempts made with a snare device and endobronchial forceps. Guided fluoroscopy demonstrated a tilted filter with some filter limbs perforating the ivc wall, and two detached filter limbs. On the third filter retrieval procedure performed, the filter and detached filter limb embedded in the ivc wall were successfully captured and retrieved using a snare device. Post filter retrieval contrast injected vena cava gram demonstrated no ivc extravasation or filling defects, no residual radiopaque foreign body was demonstrated in the ivc. No reported attempt was made to retrieve the detached limb overlying the rib.
 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6155348
MDR Text Key62234975
Report Number2020394-2016-01141
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 company representative,consum
Reporter Occupation Attorney
Type of Report Initial
Report Date 04/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
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 Treatment Data
Date Received: 12/08/2016 Patient Sequence Number: 1
Treatment
LOVENOX, COUMADIN
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