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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER Back to Search Results
Catalog Number DL950F
Device Problems Bent (1059); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2018
Event Type  Injury  
Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the denali vena cava filter products that are cleared in the us. The pro code and 510 k number for the denali vena cava filter products are identified respectively. No device, no medical records, or no medical images were provided to the manufacturer. A photo of the device was provided and is under review. The lot number for the device was not provided; therefore, a review of the device history records could not be performed. The investigation of the reported event is currently underway. 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 approximately six months post vena cava filter deployment, the filter was allegedly difficult to remove with a snare retrieval device. It was further reported that the health care provider snared the body of the filter but could not remove it through the sheath; therefore, a surgical cut down was performed and the filter was retrieved. Upon retrieval, one of the filter limbs was allegedly bent. The patient was reported as doing well.

 
Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the denali vena cava filter products that are cleared in the us. The pro code and 510 k number for the denali vena cava filter products are identified respectively. Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were not provided for review. An image was provided and reviewed. A bent filter leg could be identified in the photo. A clot around the base of the apex and hook could also be identified. Therefore, based off the photo review, the investigation can be confirmed for a bent filter limb. However, the investigation is inconclusive for difficulty to remove. Per the reported event details, the surgeons open approach had caused the filter leg to bend. However, 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.

 
Event Description

It was reported that approximately six months post vena cava filter deployment, the filter was allegedly difficult to remove with a snare retrieval device. It was further reported that the health care provider snared the body of the filter but could not remove it through the sheath; therefore, a surgical cut down was performed and the filter was retrieved. Upon retrieval, one of the filter limbs was allegedly bent. The patient was reported as doing well.

 
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Brand NameDENALI VENA CAVA FILTER
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 Key7394434
MDR Text Key104249800
Report Number2020394-2018-00336
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDL950F
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2018
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: 04/03/2018 Patient Sequence Number: 1
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