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

Model Number DL900F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Death (1802)

Event Type  Death  

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.Images were not provided.Medical records were provided and reviewed.Approximately four months post filter deployment, ct revealed the ivc filter was slightly tilted and the hook does not contact the ivc wall.Four of the ivc filter struts perforate the ivc anteriorly, medially, and posteriorly.As per ppf, the patient was deceased, but the cause of death and date of death was not provided in the medical record.Therefore, the investigation is confirmed for perforation of the ivc.However, the investigation is inconclusive for filter tilt as the medical records state the filter was tilted slightly and there is no objective evidence to confirm filter tilt.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: 04/2018).

Event Description

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 tilted and the struts perforated the ivc.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA 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 Key: 8938634
• MDR Text Key: 155775756
• Report Number: 2020394-2019-03000
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFZD0077
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/28/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Death