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

Catalog Number UNKNOWN FILTER

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 04/29/2014

Event Type  Injury  

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately one month post filter deployment, ct revealed that the infrarenal ivc was expanded with intraluminal thrombus which extended at least to the level of the filter and intraluminal hypo density within the suprarenal ivc which favored to be due to inflow phenomenon, although extension of thrombus could not be entirely excluded.Approximately two months later, patient scheduled for filter retrieval.Subsequent inferior vena cavogram revealed chronic occlusion of the ivc which encased majority of the filter.Hence, procedure was eventually aborted.Therefore, the investigation is confirmed for occlusion of the ivc filter.However, the investigation is inconclusive for filter migration, retrieval difficulties, filter tilt, perforation of the ivc.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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 occluded, tilted, migrated to renal vein and struts perforated into the organs.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

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 and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter occluded, tilted, migrated to renal vein and struts perforated into the organs.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately one month post filter deployment, ct revealed that the infrarenal ivc was expanded with intraluminal thrombus which extended at least to the level of the filter and intraluminal hypo density within the suprarenal ivc which favored to be due to inflow phenomenon, although extension of thrombus could not be entirely excluded.Approximately two months later, patient scheduled for filter retrieval.Subsequent inferior vena cavogram revealed chronic occlusion of the ivc which encased majority of the filter.Hence, procedure was eventually aborted.Therefore, the investigation is confirmed for occlusion of the ivc filter.However, the investigation is inconclusive for filter migration, retrieval difficulties, filter tilt, perforation of the ivc.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.(device: 2616 and 4001).

• Brand Name: VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9669463
• MDR Text Key: 178357032
• Report Number: 2020394-2020-00847
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 04/08/2020

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 Catalogue Number: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR