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); Malposition of Device (2616)

Patient Problem Pulmonary Embolism (1498)

Event Date 09/01/2010

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(b)(4).

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 to stop recurring blood clots from lungs and heart.At some time post filter deployment, it was alleged that filter tilted and struts perforated beyond inferior vena cava.The device was removed percutaneously after two attempted but unsuccessful percutaneous removal procedure.The patient was diagnosed with pulmonary embolism post implant.However; 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 to stop recurring blood clots from lungs and heart.At some time post filter deployment, it was alleged that filter tilted and struts perforated beyond inferior vena cava.The device was removed percutaneously after two attempted but unsuccessful percutaneous removal procedure.The patient was diagnosed with pulmonary embolism post implant.However; the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were provided and reviewed.Based on the image review,single fluoroscopic image revealed that the filter to be tilted with struts extending beyond the ivc and the filter demonstrates significant tilt.On this single subtracted image, at least one leg extends beyond the boundary of the ivc.Therefore, based on the image review the investigation is confirmed for filter tilt and perforation of the inferior vena cava (ivc).However, based on the image review the investigation is inconclusive for filter migration, retrieval difficulties and pe post implant.Based on the medical record review, approximately three years and ten months later, computed tomography (ct) revealed that the filter at l2/l3 level with approximately 53-degree angulation relative to the long axis of the inferior vena cava.Several filter struts appeared to extend beyond the wall of the inferior vena cava.Filter removal was attempted but it was unsuccessful as the filter was tilted and several of the filter struts extended beyond the inferior vena cava.As per doctor, the neck and few struts may puncture thru the inferior vena cava though currently it was walled off due to low pressure circulation.The neck was near the duodenum and the struts near the aorta.The patient admitted for saddle pulmonary embolism.Approximately three years and eight months later, the filter removed via jugular vein and right groin approach.Therefore, based on the medical records, the investigation is confirmed for filter migration, perforation of the inferior vena cava (ivc), filter tilt and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pe 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.H10: (device: 4001).H11:section a through f - the information provided by bd 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 bd.

• 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: 10716307
• MDR Text Key: 212464693
• Report Number: 2020394-2020-05994
• 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: 12/10/2020

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: 09/25/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR