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

Catalog Number UNKNOWN

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Renal Failure (2041); Transient Ischemic Attack (2109); Perforation of Vessels (2135)

Event Type  Injury  

Event Description

It is alleged that patient received a cook filter in (b)(6) 2011 due to blood clots.Patient alleges strut perforation, "kidney failure", "pain", "difficulty using right leg due to swelling & numbness" & "tia" (transient ischemic attack) without further details.

Event Description

Patient allegedly received an implant on (b)(6) 2011 via the right common femoral vein due to blood clots.Patient is alleging strut perforation.The patient further alleges ¿kidney failure, pain, difficulty using right leg due to swelling and numbness as well as tia.¿ per a ct (computed tomography) scan of the abdomen (b)(6) 2018 , ¿there is an ivc filter in place.All 3 of the legs extending 2 to 3 mm beyond the expected lumen of the inferior ivc.The legs of the stent is not obviously contact the aorta, but may contact the third portion of the duodenum.¿.

• 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: 8833478
• MDR Text Key: 152487826
• Report Number: 3005580113-2019-00078
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• 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: 08/30/2019
• Distributor Facility Aware Date: 08/29/2019
• Event Location: Other
• Date Report to Manufacturer: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR
• Patient Weight: 67