MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

Device Problems Difficult or Delayed Positioning (1157); Difficult To Position (1467); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-1-fem-celect-pt.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "the physician went with the delivery sheath into the ivc.The sheath was advanced.The filter was unsheathed and it was deployed.The filter deployed sideways and none of the legs opened.None of the secondary or primary legs opened.The physician elected to utilize a snare in an attempt to grab the filter and pulled it down.This made the filter open into the ivc.The physician also had trouble getting the snare off the anchors of the filter; however with persistence, he was able to remove the snare." patient outcome: the patient didn't have any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-fem-celect-pt.(b)(4).Summary of investigational findings: only a venogram was provided and demonstrated 19° of leftward tilt and the proximal 10 mm of filter projected outside of column of contrast, meeting the definition of penetration.In addition, primary and secondary legs along the right appeared cranially displaced resulting in tenting of the right lateral ivc wall.The venogram did not explain the reason why "the filter deployed sideways and none of the legs opened", but the sheath may have been advanced either through the ivc wall or into a collateral vein.Potentially, the filter was deployed in extracaval location, as that would inhibit the filter legs from opening normally.After deployment a snare was utilized to pull the filter caudally, at which point the legs expanded into the ivc and consequently appeared cranially displaced.It is noted that the filter placement had no adverse effects on the patient.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.

Event Description

Description of event according to initial reporter: the physician went with the delivery sheath into the ivc.The sheath was advanced.The filter was unsheathed and it was deployed.The filter deployed sideways and none of the legs opened.None of the secondary or primary legs opened.The physician elected to utilize a snare in an attempt to grab the filter and pulled it down.This made the filter open into the ivc.The physician also had trouble getting the snare off the anchors of the filter; however with persistence, he was able to remove the snare.Patient outcome: the patient didn't have any adverse effects due to this occurrence.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6217045
• MDR Text Key: 63693082
• Report Number: 3002808486-2016-01587
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)191014(10)E3507194
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Date Device Manufactured: 10/14/2016
• 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): Required Intervention
• Patient Age: 82 DA