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

Catalog Number RF048F

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Chest Pain (1776)

Event Date 07/14/2017

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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported through the litigation process that vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter migrated to heart, detached and struts perforated into organs.It was further reported that one strut retained in eleventh rib and the other strut migrated and embolized into left lower lobe pulmonary vein.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain and chest pain, 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.Medical records were provided and reviewed.Approximately one week later, pelvic arteriogram showed normal inferior vena cava filter placement.After thirteen years, inferior vena cava venogram revealed that lateral strut was missing.On the same examination on anterior posterior projection, a strut was seen overlying the left 11th posterior rib.On the same day, pulmonary angiogram showed a strut which had been migrated into a left lower lobe pulmonary vein.After one year nine months, axial computed tomography showed hook of the bard recovery retrievable inferior vena cava filter was at the l2-3 interspace.There was a strut fracture overlying the inferior aspect of the heart and embolized to the left lower lung base.Therefore, the investigation is confirmed for alleged filter limb detachment, perforation of the inferior vena cava and filter migration.Based on 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.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.

Event Description

It was reported through the litigation process that vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter migrated to heart, detached and struts perforated into organs.It was further reported that one strut retained in eleventh rib and the other strut migrated and embolized into left lower lobe pulmonary vein.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain and chest pain, however; 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 AZ 85281
• MDR Report Key: 11656097
• MDR Text Key: 245127079
• Report Number: 2020394-2021-80293
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K031328
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN, DIGOXIN AND LORAZEPAM; COUMADIN, DIGOXIN AND LORAZEPAM; ENALAPRIL, ZOLOFT AND SIMVASTATIN; ENALAPRIL, ZOLOFT AND SIMVASTATIN; COUMADIN, DIGOXIN AND LORAZEPAM; ENALAPRIL, ZOLOFT AND SIMVASTATIN
• Patient Outcome(s): Other
• Patient Age: 76 YR