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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 Problem Patient Device Interaction Problem (4001)
Patient Problem Death (1802)
Event Date 01/19/2018
Event Type  Death  
Manufacturer Narrative
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.(expiry date: 02/2017).
 
Event Description
It was reported through the litigation process that the filter struts perforated the ivc wall extending into the mesenteric fat.The current status of the patient is unknown.New information: it was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.
 
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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately two years later, patient was implanted with another bard eclipse vena cava filter in the infra renal location due to deep vein thrombosis and pulmonary embolism.Approximately three years post filter deployment, ct revealed the filter struts penetrated through the ivc wall into the pericaval/mesenteric fat.Approximately, 10 months later, patient expired.Therefore, the investigation is confirmed for perforation of the ivc.Based upon 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: 02/2017).
 
Event Description
It was reported through the litigation process that the filter struts perforated the ivc wall extending into the mesenteric fat.The current status of the patient is unknown.New information: it was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.
 
Event Description
It was reported through the litigation process that the filter struts perforated the ivc wall extending into the mesenteric fat.The current status of the patient is unknown.New information: it was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated into the organs.The device was removed percutaneously.The patient reportedly expired.
 
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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately two years later, patient was implanted with another bard eclipse vena cava filter in the infra renal location due to deep vein thrombosis and pulmonary embolism.Approximately three years post filter deployment, ct revealed the filter struts penetrated through the ivc wall into the pericaval/mesenteric fat.Approximately, 10months later, patient expired.Therefore, the investigation is confirmed for perforation of the ivc.Based upon 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.H10: b5,d4(expiry date: (b)(6) 2017.
 
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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
MDR Report Key8929824
MDR Text Key155479646
Report Number2020394-2019-02918
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEC500F
Device Lot NumberGFYA2840
Was Device Available for Evaluation? No
Date Manufacturer Received02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADVAIR, ZOFRAN, INDERAL, IMITREX; ADVAIR, ZOFRAN, INDERAL, IMITREX; ADVAIR, ZOFRAN, INDERAL, IMITREX; DIAZEPAM, ESCITALOPRAM, FLUPHENAZINE; DIAZEPAM, ESCITALOPRAM, FLUPHENAZINE; DIAZEPAM, ESCITALOPRAM, FLUPHENAZINE; ELIQUIS, LOVENOX, WARFARIN, DUONEB; ELIQUIS, LOVENOX, WARFARIN, DUONEB; ELIQUIS, LOVENOX, WARFARIN, DUONEB; FOLIC ACID, ATIVAN, PROVENTIL, FOSAMAX; FOLIC ACID, ATIVAN, PROVENTIL, FOSAMAX; FOLIC ACID, ATIVAN, PROVENTIL, FOSAMAX; LEVAQUIN, KLOR-CON, PREDNISONE, PROTONIX; LEVAQUIN, KLOR-CON, PREDNISONE, PROTONIX; LEVAQUIN, KLOR-CON, PREDNISONE, PROTONIX; OLANZAPINE, QUETIAPINE, AMITRIPTYLINE; OLANZAPINE, QUETIAPINE, AMITRIPTYLINE; OLANZAPINE, QUETIAPINE, AMITRIPTYLINE; VITAMIN D2, GABAPENTIN, LORAZEPAM, MIRTAZAPINE; VITAMIN D2, GABAPENTIN, LORAZEPAM, MIRTAZAPINE; VITAMIN D2, GABAPENTIN, LORAZEPAM, MIRTAZAPINE; ZOLMITRIPTAN; ZOLMITRIPTAN; ZOLMITRIPTAN; ADVAIR, ZOFRAN, INDERAL, IMITREX; DIAZEPAM, ESCITALOPRAM, FLUPHENAZINE; ELIQUIS, LOVENOX, WARFARIN, DUONEB; FOLIC ACID, ATIVAN, PROVENTIL, FOSAMAX; LEVAQUIN, KLOR-CON, PREDNISONE, PROTONIX; OLANZAPINE, QUETIAPINE, AMITRIPTYLINE; VITAMIN D2, GABAPENTIN, LORAZEPAM, MIRTAZAPINE; ZOLMITRIPTAN
Patient Outcome(s) Death;
Patient Age54 YR
Patient Weight68
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