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

Model Number	G48378
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	09/17/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref#.(b)(4).D4) catalog # igtcfs-65-uni-celect-perm.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: it is alleged that "[pt] received a cook celect filter on (b)(6) 2015".Additional information received 14sep2017: patient received an implant on (b)(6) 2015 via the right common femoral vein due to motor vehicle accident, pulmonary embolism.Patient outcome: patient experiences device unable to be retrieved, tilt; patient is alleging migration, anxiety.Retrieval was attempted on (b)(6) 2015.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'device unable to be retrieved, tilt, migration, anxiety'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Unknown if the reported anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.

• Brand Name: COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6907200
• Report Number: 3002808486-2017-01888
• Device Sequence Number: 1208939
• Product Code: DTK
• UDI-Device Identifier: 00827002483781
• UDI-Public: (01)00827002483781(17)160807(10)E3243832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K073374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G48378
• Device Catalogue Number: IGTCFS-65-UNI-CELECT-PERM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/14/2017
• Device Age: 13 MO
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 80