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

Catalog Number MD800F

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Bowel Perforation (2668)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 09/2012.

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.After some time post filter deployment, it was alleged that the filter struts perforated.The device has been removed percutaneously.The patient had surgery for perforated duodenum.However, the current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.After post filter deployment, patient presents with filter caval perforation and filter legs are within the renal hilum.Recently the patient had surgery for perforated duodenum.Approximately six years and ten months later, the patient presented for filter removal, the right internal jugular vein was percutaneously accessed with a micro-puncture set.A wire was advanced under fluoroscopic guidance into the inferior vena cava.Serial dilatations were performed over the wire to accommodate placement of the filter retrieval sheath.The sheath was advanced beyond the filter into the distal and inferior vena cava.Inferior vena cava gram revealed no evidence of thrombus within the filter.Next using a goose neck snare, the retrieval hook was grasped.The sheath was then used to collapse the filter and removed in its entirety.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava (ivc).The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 09/2012 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.

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.After some time post filter deployment, it was alleged that the filter struts perforated.The device has been removed percutaneously.The patient had surgery for perforated duodenum.However, the current status of the patient is unknown.

• Brand Name: MERIDIAN FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11559560
• MDR Text Key: 241953658
• Report Number: 2020394-2021-00655
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K112497
• 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: 05/14/2021

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: MD800F
• Device Lot Number: GFVI0121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR