MAUDE Adverse Event Report: C.R. BARD INC. DENALI FEMORAL IVC FILTER; FILTERM INTRAVASCULAR, CARDIOVASCULAR

Catalog Number DL900F

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 01/09/2020

Event Type  Death  

Event Description

Pt expired due to cardiopulmonary arrest.One of the pins of the ivc filter embolized to the heart.Fda safety report id# (b)(4).

• Brand Name: DENALI FEMORAL IVC FILTER
• Type of Device: FILTERM INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): C.R. BARD INC.
• MDR Report Key: 9595842
• MDR Text Key: 175370554
• Report Number: MW5092261
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: DL900F
• Device Lot Number: GFDX0630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 28