MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Migration is addressed in the ifu.Event is still under investigation at this time.

Event Description

A journal article alleged that a (b)(6) gentleman with protein s deficiency (resulting in a hypercoagulable state) with multiple venous thromboembolic events (including massive pe) requiring urgent surgical thrombectomy), underwent placement of a cook bird's nest ivc filter 16 years earlier.On a chest ct scan performed for shortness of breath and sharp lower chest pain a year earlier, abdominal levels showed fracture of ivc filter and penetration of one of the upper hook wire struts into the thoracic aorta.A repeat ct performed a year later showed continuous migration of hook wire strut into the thoracic aorta.Based on the continuous migration of this fragment through the aortic wall (in a patient on chronic anticoagulation), it was felt that retrieval was warranted.From a planning perspective, the case was reviewed by both vascular surgery and interventional cardiology.A decision was made to approach the retrieval percutaneously in a hybrid or setting designed for both endovascular and vascular surgical procedures.The patient bridged from coumadin to lovenox in preparation for the procedure.The patient had full body fluoroscopy (torso, pelvis, and bilateral lower extremities) to confirm the findings on ct and in anticipation for retrieval strategy.Fluoroscopy demonstrated a bird's nest ivc filter in the ivc that had broken into multiple pieces.There was a separate fragment in the thoracic aorta.The fragment in the interest was defined under fluoroscopy in the descending thoracic aorta at level of t12.Probing was performed gently with a 2.4,, jaw forcep (bioptome,), but the authors were unable to grasp on to the fragment.A 25-mm amplatz gooseneck snare (another manufacturer) was advanced and manipulated to grasp the top portion of the fragment.With gentle tension, the fragment was removed easily from the wall.The fragment was captured and pulled through a 7fr-sheath femoral arterial sheath.Aortography was performed via pigtail catheter and revealed that the aorta was patent in that area with no evidence of perforation.Angiography of the ivc revealed a fibrotic portion with mild stenosis just below the bird's nest device.The patient tolerated the procedure well and was discharged the next day.The patient remains in stable condition at 12-month follow- up.Journal article: touchan, jean, md, et al: percutaneous retrieval of fractured bird's nest ivc filter penetrating into aorta catheterization and cardiovascular interventions 80: 657-990.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, drawings, instructions for use (ifu), manufacturing instructions, specifications and quality control was conducted during the investigation.The device is shipped with an ifu which lists the anatomical requirements, warnings and precautions, and correct deployment procedure.The exact ifu is dependent on product size and placement approach.Without the exact device rpn, we cannot determine the exact ifu.However, in each ifu, perforation of vena cava wall is listed as a potential adverse event the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record and non-conformances was not able to be completed as the lot number was not available.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

A journal article alleged that a (b)(6) gentleman with protein s deficiency (resulting in a hypercoagulable state) with multiple venous thromboembolic events (including massive pe) requiring urgent surgical thrombectomy), underwent placement of a cook bird's nest ivc filter 16 years earlier.On a chest ct scan performed for shortness of breath and sharp lower chest pain a year earlier, abdominal levels showed fracture of ivc filter and penetration of one of the upper hook wire struts into the thoracic aorta.A repeat ct performed a year later showed continuous migration of hook wire strut into the thoracic aorta.Based on the continuous migration of this fragment through the aortic wall (in a patient on chronic anticoagulation), it was felt that retrieval was warranted.From a planning perspective, the case was reviewed by both vascular surgery and interventional cardiology.A decision was made to approach the retrieval percutaneously in a hybrid or setting designed for both endovascular and vascular surgical procedures.The patient bridged from coumadin to lovenox in preparation for the procedure.The patient had full body fluoroscopy (torso, pelvis, and bilateral lower extremities) to confirm the findings on ct and in anticipation for retrieval strategy.Fluoroscopy demonstrated a bird's nest ivc filter in the ivc that had broken into multiple pieces.There was a separate fragment in the thoracic aorta.The fragment in the interest was defined under fluoroscopy in the descending thoracic aorta at level of t12.Probing was performed gently with a 2.4, jaw forcep (bioptome,), but the authors were unable to grasp on to the fragment.A 25-mm amplatz gooseneck snare (another manufacturer) was advanced and manipulated to grasp the top portion of the fragment.With gentle tension, the fragment was removed easily from the wall.The fragment was captured and pulled through a 7fr-sheath femoral arterial sheath.Aortography was performed via pigtail catheter and revealed that the aorta was patent in that area with no evidence of perforation.Angiography of the ivc revealed a fibrotic portion with mild stenosis just below the bird's nest device.The patient tolerated the procedure well and was discharged the next day.The patient remains in stable condition at 12-month follow- up.Journal article: touchan, jean, md, et al: percutaneous retrieval of fractured bird's nest ivc filter penetrating into aorta catheterization and cardiovascular interventions 80: 657-990.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5720256
• MDR Text Key: 47227163
• Report Number: 1820334-2016-00474
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2016
• 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: 54 YR