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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problems Bent (1059); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device with 510(k) 121629.(b)(4).Summary of investigational findings: visual inspection of the filter confirms that one secondary filter leg is fractured close to the clip bushing.It is strongly indicated that the filter leg was bent right where the fracture occured.Sem analysis performed did not show evidence to suggest nonconformances on the wire surface.Imaging indicates that the filter was placed from femoral approach and more cranial than recommended, however, without significant tilt.Two secondary filter legs were extending into the ostium of right renal vein after deployment of the filter.Imaging from second retrieval attempt confirms that one secondary filter leg, centered and well positioned within the ivc, fractured.This leg appeared to be within the loop snare on the imaging same time as the loop snare was around the filter.The fractured piece embolized to pulmonary artery.The fractured piece was left inside the patient.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 fracture of the wire is an uncommon, but known risk in relation to filter implant.However, the filter fracture occurred during retrieval and not during the implant period.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 complainant: during the retrieval of the vena cava filter one leg did snap over, parts remained in patient.At (b)(6) 2015 a vena cava implantation was performed - no problem during the procedure.First retrieval was attempted at (b)(6) 2015, but it failed.During the procedure they saw that one of the filter legs was bend 180 degrees to cranial.The procedure was stopped there.A second attempt to retrieval the filter was at (b)(6) 2015.First they have tried to get the filter leg in the right position by using the; lassos- snare from osypka and this worked and the filter looked like normal.Then they used the global snare and retrieved the filter from jugular, after retrieval they have lost one leg of the filter, in xray they saw that the missing leg was in pulmonary artery.They have decided to leave the leg there and hope for ingrowth of the fragment.Patient outcome: a section of the device did remain inside the patient¿s body.The missing leg is in the pulmonary artery.The patient did require additional procedures due to this occurrence.Second retrieval attempt, and ct scan.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: 5888272
• MDR Text Key: 52491533
• Report Number: 3002808486-2016-00886
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)180612(10)E3338344
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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): Other
• Patient Weight: 90