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

Catalog Number RF048F

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Cardiac Perforation (2513)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the sample was returned for evaluation, as well as medical records were provided for review.Based on the observation from the sample evaluation, one recovery filter was returned for evaluation.Gross, microscopic visual, dimensional and calibration evaluations were performed.The device was returned with one detached arm.Two feet are missing and were not returned.Therefore, based on the sample evaluation, the investigation is confirmed for limb detachment.However, the investigation is inconclusive for retrieval difficulties.Based on the provided medical record, approximately fifteen years post filter deployment, the patient presented with chest pain.Subsequent computed tomography (ct) revealed that a new linear metallic foreign body within the anterior aspect of the right ventricle.A portion of this foreign body protruded outside the right ventricle.One day later, xr-abdomen 1 view showed the inferior vena cava filter projecting over the inferior vena cava unchanged in position compared to previous studies.Subsequently next day, another computed tomography chest cardio coronary (ct) revealed that the embolized inferior vena cava filter strut in right ventricle apex extending from the pericardial surface into the right ventricle.Approximately 1 cm of the strut appeared to be intraventricular.Eventually, filter and strut removal were scheduled.Through the, right transverse jugular vein and 6f sheath was advanced into the right ventricle of the heart.Then, a 4 f catheter and a 10mm in diameter gooseneck snare was used to grasp the intraluminal free end of the fractured arm of the strut within the right ventricle of the heart.The strut was then removed through a 6f sheath.Multiple attempts were made to grasp the nose of the bard recovery filter with transbronchial forceps were made but to no avail.The recovery cone was used to grasp the nose of the filter which was removed uneventfully through the 16f sheath.5 arms and 6 legs were documented on the bard recovery filter.Based on the medical record review, the investigation is confirmed for filter limb detachment and retrieval difficulties.Therefore, the investigation is confirmed for filter limb detachment and retrieval difficulties.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.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 approximately fifteen years post vena cava filter deployment, one limb of the filter was allegedly detached.It was further reported that the filter and the filter limb were removed.There was no reported patient injury.

• Brand Name: RECOVERY FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11250036
• MDR Text Key: 229291772
• Report Number: 2020394-2021-80138
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 98