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

Model Number DL900J

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

Patient Problem Death (1802)

Event Date 07/09/2016

Event Type  Death  

Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately ten months post filter deployment, ct revealed six prongs had perforated the ivc with a maximum distance prongs perforation is 2 mm.Therefore, the investigation is confirmed for perforation of the ivc.However, the investigation is inconclusive for 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.

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 embedded in the wall of ivc and six struts perforated the ivc with a maximum distance of 2 mm.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 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 embedded in the wall of ivc and six struts perforated the ivc with a maximum distance of 2 mm.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.

Manufacturer Narrative

H10: manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately ten months post filter deployment, ct revealed six prongs had perforated the ivc with a maximum distance of 2 mm.Coronal images demonstrated a tilt of 5 degrees left to right.Approximately two years later, patient reportedly expired due to cardiopulmonary arrest.Therefore, the investigation is confirmed for perforation of the ivc.However, the investigation is unconfirmed for filter tilt as the medical records state only 5 degrees tilt left to right.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.

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9479015
• MDR Text Key: 171544146
• Report Number: 2020394-2019-05638
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR