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

Catalog Number UNKNOWN

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problems Occlusion (1984); Thrombus (2101); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient allegedly received an implant on (b)(6) 2010 via the right common femoral vein due to history of pulmonary embolism(pe), per medical record received.Per a (b)(6) 2010 unsuccessful filter retrieval: "after several attempts, passage of the micro guidewire to the inferior vena cava was not possible, suggesting occlusion of the superior vena cava.Injection of contrast, also revealed tortuous, collateral venous filling in the neck.Impression: patent inferior vena cava with no clot formation noted.Getting access to the superior vena cava, because of the occlusion of the vein was not possible".Per a (b)(6) 2019 computed tomography (ct) abdomen: "ivc filter: there is an intact ivc filter with anterior tilt, 19.1 degrees.Tip of the ivc filter is located at the level of the left renal vein and 2 cm superior to the right renal vein.Four of the struts extend 3 mm beyond the lumen of the the ivc at the right anterior, right posterior, left posterior, and left anterior aspects.There is calcified thrombus extending over a length of 2.9 cm, extending 1.1 cm superiorly from the tip of the ivc filter".

• 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: 9859789
• MDR Text Key: 188825461
• Report Number: 3005580113-2020-00295
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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: 03/20/2020
• Distributor Facility Aware Date: 03/04/2020
• 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