MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Fracture (1260); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Description of event according to initial reporter: it is alleged that patient received a cook celect filter on (b)(6) 2013.The patient reportedly experienced filter fracture, organ/ vena cava perforation by the filter, and filter tilt.Ct (computed tomography): "inferior vena cava filter at the level of the renal veins with multiple prongs extending to the caval wall and into the surrounding structures, including a prong piercing the anterior inferior parenchyma of the right kidney with an area decreased surrounding enhancement." "there is an inferior vena cava filter at the level of the renal veins.Two of the posterior prongs extend through the cava wall into the ipsilateral psoas muscle.Two of the right-sided prongs extend and terminate in the right renal vein.One of the right-sided prong extends through the caval wall and into the parenchyma of the anterior inferior kidney.The surrounding parenchyma demonstrates decreased enhancement around this prong.In addition, there is an anterior prong which extends through the anterior portion of the caval wall.There is a left-sided prong which extends to the caval wall and into the prevertebral soft tissues." successful retrieval report: "scout images demonstrated a tilted ivc filter with 2 struts with caval penetration." "post filter removal venogram did not demonstrate extravasation." "scout images of the chest and abdomen did not demonstrate evidence for any retained filter fragments." "tilted infrarenal celect ivc filter with leg perforating into the right renal parenchyma.One upper stabilizing strut is fractured.Successful removal of indwelling ivc filter in its entirety using endobronchial forceps.The fragment was removed as well separately using forceps.".

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9889351
• MDR Text Key: 188824756
• Report Number: 3005580113-2020-00310
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2020
• Distributor Facility Aware Date: 03/11/2020
• Event Location: Other
• Date Report to Manufacturer: 03/03/2020
• 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): Life Threatening