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

Catalog Number MD800F

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned, however medical records were provided for review.The investigation is currently underway.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.The reported information indicates that model md800f vena cava filter allegedly experienced obstruction within device, tilt, and perforation.The information was received from one source.The malfunction involved a patient with no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) lbs.

Manufacturer Narrative

H10: the lot number was provided for the reported malfunction and a lot history review was performed.The device was not returned, however medical records were provided for review.The investigation confirmed for obstruction within device, but is inconclusive for patient device interaction and malposition of device.A root cause could not be determined.The device is labeled for single use.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

This report summarizes one malfunction.The reported information indicates that model md800f vena cava filter allegedly experienced obstruction within device, malposition of device, and patient device interaction problem.The information was received from one source.The malfunction involved a patient with no reported patient injury.The male patient is 50 years old and weighs 190 lbs.

Manufacturer Narrative

H10: the lot number was provided for the reported malfunction and a lot history review was performed.The device was not returned, however, medical records were provided and reviewed.The investigation is confirmed for occlusion of the inferior vena cava (ivc) filter and retrieval difficulties.However, the investigation is inconclusive for perforation of the inferior vena cava (ivc) and filter tilt.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.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

This report summarizes one malfunction.The reported information indicates that model md800f vena cava filter allegedly experienced obstruction within device, malposition of device, difficult to retrieve and perforation.The information was received from one source.The malfunction involved a patient with no reported patient injury.The male patient is 50 years old and weighs 190 lbs.

• Brand Name: MERIDIAN FILTER - 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: 9596115
• MDR Text Key: 178355515
• Report Number: 2020394-2020-00432
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MD800F
• Device Lot Number: GFVI0116
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 03/26/2020; 03/31/2022
• Supplement Dates FDA Received: 04/01/2020; 04/11/2022
• Type of Device Usage: A
• Patient Sequence Number: 1