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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDAN FILTER SYSTEM VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. MERIDAN FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number MERIDIAN
Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative

The lot number was not provided; therefore, the device history records could not be reviewed. The investigation is currently underway.

 
Event Description

It was reported that approximately three years post vena cava filter deployment, during scheduled vena cava filter retrieval a snare device was used to successfully capture and retrieve the filter w/out difficulty. Upon removal of the filter, visual inspection identified a missing filter limb. Guided fluoroscopy was unable to identify the detached filter limb location post filter retrieval the detached filter limb was not identified prior to the filter retrieval. The health care provider stated that the patient was asymptomatic & no further treatment or testing is planned at this time.

 
Manufacturer Narrative

Manufacturing review: a manufacturing review was unable to be performed as the lot number was not provided. Visual/microscopic inspection: the filter contained all 5 arms and 6 legs present and intact. An arm with shoulder anchor was detached and not returned. The arm was detached near the apex; however the exact location could not be measured due to fibrotic tissue. Dimensional evaluation: heat was applied and the filter took the appropriate shape. All measurements met the required specifications. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: the photo shows a meridian filter on white surface. Fibrotic tissue can be seen around the apex of the filter. Six legs and five arms are present and intact. One arm (w/shoulder anchor) is detached from the filter and not visible in the photo. No portion of the detached arm appears to be attached to the filter; however due to the fibrotic tissue, the exact location of the fracture can not be identified. Based on the photo provided, a detached filter arm can be confirmed. Conclusion: the filter was returned. One photo was provided. Based on the returned sample condition and the photo review, the investigation is confirmed for a detached filter arm. Based upon the available information, the definitive root cause for this event is unknown. It is unknown if patient and/or procedural factors contributed to the reported event. 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. 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.

 
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Brand NameMERIDAN FILTER SYSTEM
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804 2045
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key4990539
MDR Text Key22731769
Report Number2020394-2015-01283
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PHYSICIAN
Type of Report Initial,Followup
Report Date 07/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMERIDIAN
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/24/2015
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2015
Was Device Evaluated By Manufacturer? Yes
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: 08/05/2015 Patient Sequence Number: 1
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