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

Catalog Number RF048F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Cardiac Perforation (2513)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the reported 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.One image was reviewed.The xray image shows the recovery ivc filter in the abdomen with some disfigurement and a fractured strut that has migrated into the vena cava wall.This a contrast study with a large sheath in place.There is no evidence of contrast extravasation.There is some tilt to the filter.Medical records were provided and reviewed.Post filter deployment, a computed tomography of abdomen and pelvis showed that an umbrella type filter shows it leg deployed within the high intrahepatic and subdiaphragmatic inferior vena cava.The cone of the inferior vena cava protrudes into the right atrium.There is no thrombus within either of the right atrium or inferior vena cava.One of the right anterolateral legs of the inferior vena cava filter protrudes slightly through the capsule of the medial dome of the liver and there is another protruding slightly beyond the right side of the lumen into the epicardial fat.Around one day later, an echocardiogram was performed for the history of inferior vena cava filter evaluation showed that inferior vena cava appears mildly dilated, there is an echogenic structure within the inferior vena cava/ra junction, likely displaced filter.Around eleven months and twenty-two days later, a computed tomography angiogram of abdomen and pelvis showed that once again noted is an umbrella type filter deployed at the confluence of the inferior vena cava and right atrium.The cone of the filter protrudes into the right atrium.The legs are deployed in the intrahepatic inferior vena cava with one right anterolateral leg protruding into the adjacent liver and another protruding into the right epicardial fat.Therefore, the investigation is confirmed for the reported perforation of inferior vena cava and filter migration.Additionally, the investigation is confirmed for the identified filter tilt and filter strut detachment.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that an inferior vena cava filter was deployed for a patient and at some time later post filter deployment, the cone of the filter allegedly protruded in to the right atrium.It was further reported that one of the anterolateral strut had protruded into the adjacent liver and another strut had protruded into the right epicardial fat.Furthermore, the filter was allegedly found to be displaced.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18461104
• MDR Text Key: 332250783
• Report Number: 2020394-2023-01359
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2023

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: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/06/2024
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male