MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G48372
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been reported by the manufacturer under mdr# 3002808486-2019-01549.
Event or Problem Description
According to initial reporter: "a fracture had occurred at an unknown time after filter placement.Filter placement occurred in 2010.A single primary strut was found fractured.It sat perforating the ivc just below the main body of the filter.Patient was asymptomatic so the decision was made to leave the fractured strut as to not make the situation worse.The main body of the filter was successfully retrieved." per medwatch report - pt had ivc filter placed (b)(6) 2010.Recent radiology tests performed showed ivc filter fracture and perforation of one strut into infrarenal aorta.Ivc filter with 3 remaining primary struts intact and 8 secondary struts intact removed via interventional radiology procedure (b)(6) 2019.1 strut retained in infrarenal aorta (extraluminal) due to high risk of hemorrhage if removed.

• Brand Name: COOK CELECT JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9156771
• Report Number: 3005580113-2019-00483
• Device Sequence Number: 1848788
• Product Code: DTK
• UDI-Device Identifier: 00827002483729
• UDI-Public: (01)00827002483729(17)120709(10)E2617972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2019
• Report Date (Section F): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2012
• Device Model Number: G48372
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2617972
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2019
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 62 YR
• Patient Weight: 59
• Date Report Sent to FDA: 10/04/2019