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 Fracture (1260); Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-2-uni-celect-pt.Name and address for importer site: (b)(4).Similar to device under 510(k) k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "they have retrieved a celect filter to find a secondary strut has fractured off and is left within the patient".As per rep: "routine filter retrieval.No complications during the procedure but dr noticed that the filter appeared twisted and the nurse counted the legs to find one missing.It is visible in the patients ivc".Patient outcome: the patient did require an additional procedure due to this occurrence: "ct scan and may require a further ct abdo in the future".According to the initial reporter, the patient did experience adverse effects: "the patient will require monitoring".

Manufacturer Narrative

Exemption number e2016032.Manufacturer ref# (b)(4).Summary of investigational findings: investigation is based on event description, returned device and image review.The celect-pt filter was returned and one of the secondary filter legs had fractured close to the clip bushing.A detailed sem investigation revealed no sign of material defect or inclusion, but the fracture being caused by manipulation/fatigue; the fractured leg had three surfaces, one covers 40% of the filter leg and is smooth and beginning from the outer of the leg moving towards the filter cone.Two minor surfaces are also smooth, but appear twisted approx.120°compared to the 40% surface.Based on these findings the fracture was clearly caused by manipulation/fatigue of the filter leg in three different directions.Venogram at time of initial ivc filter placement demonstrates a celect-pt filter deployed via a femoral approach in an infrarenal location.The post deployment images, unfortunately, are of low resolution and the secondary legs are not clearly identified.The distribution of the primary filter legs gives the impression of a twisting of the ivc filter, but this may be projectional and cannot be confirmed on the single image submitted.On a follow-up venogram obtained 2 months later at time of ivc filter retrieval, a secondary leg has fractured from the ivc filter and is located in a near perpendicular orientation to the long axis of the filter, just caudal to the filter hook.In addition, multiple other secondary legs appear intertwined with one another and are not appropriately distributed throughout the ivc.There is perforation involving at least two of the primary filter legs as well.The ivc filter was retrieved and the follow-up x-rays demonstrate the residual fractured secondary limb in an identical position when compared to the pre-retrieval images, suggesting it is extravascular.There is no comment in the complaint report regarding attempting to retrieve this fractured fragment.Following ivc filter retrieval, a ct scan of the chest was obtained demonstrating no evidence of filter fragment embolization to the heart or pulmonary arteries.The residual fractured fragment was not imaged to determine if there is any intravascular component or if it is entirely extravascular, an important differentiating factor to help determine the likelihood of embolization or injury to any adjacent structures in the future.Filter fracture is a rare complication of an ivc filter, and is typically associated with a long dwell time or some other compounding factor.At the time of initial ivc filter placement, the secondary legs are not readily seen due to the low resolution of the image.Given the filter was deployed via a femoral approach, it is a possibility that the filter was inadvertently pulled caudally after the secondary legs were unsheathed, allowing a secondary leg to be displaced cranially resulting in abnormal forces at the junction of the secondary leg, thus contributing to the development of a fracture.Alternatively, if the filter was twisted in the deployment sheath resulting in the abnormal distribution of the secondary legs throughout the ivc, this too could have contributed to the development of a fracture.The complaint report also alludes to the patient undergoing surgery, but does not describe what the surgical procedure was, or if there is any potential for manipulating the ivc in the region of the ivc filter during the surgery, which has been reported in the literature to result in penetration, and could potentially contribute to a filter fracture.Without additional clinical information, and/or higher quality images from time of ivc filter deployment, determining the exact cause of the filter fracture is not possible.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), 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.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that filter fragment embolized into the heart or lung may be safely retrieved.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® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7163149
• MDR Text Key: 96335241
• Report Number: 3002808486-2018-00005
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)200424(10)E3576783
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/08/2017
• Device Age: 8 MO
• Date Manufacturer Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR