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

Catalog Number UNKNOWN FILTER

Device Problems Break (1069); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation as well as image and photos were provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that post filter placement procedure, the leg of the filter allegedly broke off and migrated to the patient's lung.The device was reported to be removed.The current status of the patient is unknown.

Event Description

It was reported that post filter placement procedure, the leg of the filter allegedly broke off and migrated to the patient's lung.It was further reported that filter was removed.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one x-ray centered around the right lower chest was reviewed.An object resembling an ivc filter leg is visualized in the right lung field.The inferior vena cava filter is not visualized in the provided image.Based on the image review the reported filter limb detachment can be confirmed.Three electronic photos were reviewed.Photo one shows the top portion of the filter.Photo two shows the filter in deployed position.It was observed that one of the filter arm was found to be missing in both the photos.Blood residue was noted on the arms and legs.The third photo shows the patient details.Based on the photo review, the reported filter limb detachment can be confirmed.One denali filter was returned for evaluation.The filter was received in a specimen cup in a deployed position.Blood residue was noted on arms and legs.One of the filter arm was found to be missing.Therefore, based on the provided photo and image review and the returned sample evaluation, the investigation is confirmed for the filter limb detachment.A definitive root cause for the reported filter limb detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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: 12517506
• MDR Text Key: 272861787
• Report Number: 2020394-2021-01786
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Date Manufacturer Received: 10/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR