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	Malposition of Device (2616); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Catalog #: igtcfs-65-uni-celect-perm.The 510(k) could be either k061815 or k073374.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: a celect filter placed 2 years prior was tilted and perforating the ivc.In the images you can see the secondary legs look odd and once it was removed one of the secondary leg was wrapped around primary leg.The filter came out smooth with no harm to the patient.Patient outcome: the patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).(b)(4).Summary of investigational findings: investigation is based on description of event and returned product.According to the description of event, the celect filter was tilted and perforated the ivc.Furthermore "in the images you can see the secondary legs look odd and once it was removed one of the secondary leg was wrapped around primary leg." it is noted that the filter was retrieved and no harm was done to the patient.The celect filter is returned; there is some tissue around the clipbushing, and a few of the secondary legs was out of shape.After the tissue has been removed, it is noted that all the secondary legs are located correctly in the clipbushing.One secondary leg is pressed against the filter center.However, the root cause for the reported tilt and perforation cannot be determined, since no imaging was provided to assist the investigation.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.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.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.Cook medical will continue to monitor for similar events.

• 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: 6386528
• Report Number: 3002808486-2017-00719
• Device Sequence Number: 735635
• Product Code: DTK
• UDI-Device Identifier: 00827002483781
• UDI-Public: (01)00827002483781(17)161103(10)E3271104
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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?: Yes
• Distributor Facility Aware Date: 02/21/2017
• Device Age: 28 MO
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1