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

Catalog Number MD800F

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 11/20/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the 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 few days post filter deployment, computed tomography revealed the filter was positioned below the renal veins.Two of the filter legs were penetrating the anterior wall of the inferior vena cava into the pericaval/mesenteric fat.Approximately six years later, computed tomography performed due to intermittent abdominal pain revealed an inferior vena cava filter was in place with its tip at inferior end plate of l1 at the level of the renal vessels.A broken strut of the inferior vena cava filter was noted along the right side and appeared to extend extra luminal.Another strut along the right lateral aspect appeared to extend in the adjacent soft tissues.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter migration and filter limb detachment.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.

Event Description

It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with deep vein thrombosis.Approximately two weeks post filter deployment, computed tomography (ct) abdomen was performed and it revealed that the filter struts perforated.Approximately five years and two months post filter deployment, computed tomography (ct) abdomen was performed and it revealed that the filter struts detached and filter migrated.The device has not been removed and there were no attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; 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
• 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: 10604451
• MDR Text Key: 209136501
• Report Number: 2020394-2020-05867
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• 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): Other
• Patient Age: 52 YR
• Patient Weight: 53