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

Model Number N/A

Device Problems Difficult to Remove (1528); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Event Description

Description according to article "inferior vena cava filter retrieval: effectiveness and complications of routine and advanced techniques." the only complication associated with routine technique was an ivc intussusception.The hook of the filter was snared without difficulty, but the sheath could not be fully advanced over the filter despite a large amount of tension.When tension was released, the filter legs were coapted, resulting in severe ivc stenosis, which was treated with interfilter angioplasty, resulting in moderate ivc stenosis (sir major complication, grade c).

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

During the course of investigation, a review of the complaint history, manufacturing instructions (mi), and quality control (qc) was conducted.No product was returned, however, images were provided, which were sent for outside clinical review.Per outside clinical review.Two images of filter provided; the first demonstrates the tulip filter in ivc, just prior to attempted removal.One right leg and likely one left leg have perforated.Perforated right leg distal wire loop is also outside ivc.Second image demonstrates collapse of filter and pleating of ivc walls by at least two filter legs filter is twisted at least 90 degrees.Twist is evident in proximal filter wires and hook position.Other than central gathering and 15mm of superior displacement, the relative leg positions are stable.A linear filling defect surrounding superior portion of filter and extending superiorly into ivc may represent new thrombus, but more likely represents partial ivc wrapping around twisted filter.This would occur if secondary wires were adherent to ivc wall.An intussusception is defined as telescoping of a hollow viscous inside of itself.This occurs along the long axis of viscous.There's is no evidence to suggest this type of deformity on image instead image is more consistent with at least 90 degrees of mid-and proximal filter twist upon attempted removal.When hock is twisted, filter should return to its original position unless wires have bent or legs have rotated along with proximal filter in this case, no leg rotation occurred, so proximal filter wires must have bent while being twisted ivc appearance is more consistent with partial ivc wrapping around twisted filter.This would explain persistent stenosis rather than usual return to original position.A bent filter would also explain why angioplasty could only partially reduce stenosis.No evidence to suggest that this device was not manufactured according to specifications.This device is shipped with an instructions or use (ifu), which states that excessive force should not be used to retrieve the filter.The ifu also lists "acute damage to the inferior vena cava" as a possible adverse event.To evaluate the safety of retrieving the gunther tulip vena cava filter, a clinical study was conducted in which 41 patients were enrolled for possible retrieval of the filter.The results of this and other published and presented sources are listed in the ifu and demonstrate that the gunther tulip vena cava filter may be safely retrieved.The complaint device was not returned for inspection.Without more information on the patient anatomy and condition as well as dwell time of the device it is not possible to determine a root cause of this event.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), the addition of this complaint does not change the conclusion that further risk reduction is not required.

Event Description

Description according to article provided to cook "inferior vena cava filter retrieval.Effectiveness and complications of routine and advanced techniques." ramsey ai-hakim et al.According to the article: the only complication associated with routine technique was an ivc intussusception.The hook of the filter was snared without difficulty, but the sheath could not be fully advanced over the filter despite a large amount of tension.When tension was released, the filter legs were coapted, resulting in severe ivc stenosis, which was treated with intrafilter angioplasty, resulting in moderate ivc stenosis.Additional information regarding patient outcome was not provided.

Manufacturer Narrative

Based on review of the record, it did not appear the journal article referenced was previously submitted with the medwatch report.We have attached the journal article as referenced in the event description and provided additional information for the investigation results.(b)(4).Investigation- during the course of investigation, a review of the complaint history, manufacturing instructions (mi), and quality control (qc) was conducted.No product was returned; however, images as were provided in the journal article, were sent for outside clinical review.Per outside clinical review: the journal article and two images of filter provided; the first demonstrates the tulip filter in ivc, just prior to attempted removal.One right leg and likely one left leg have perforated.Perforated right leg distal wire loop is also outside ivc.Second image demonstrates collapse of filter and pleating of ivc walls by at least two filter legs.Filter is twisted at least 90 degrees.Twist is evident in proximal filter wires and hook position.Other than central gathering and 15mm of superior displacement, the relative leg positions are stable.A linear filling defect surrounding superior portion of filter and extending superiorly into ivc may represent new thrombus, but more likely represents partial ivc wrapping around twisted filter.This would occur if secondary wires were adherent to ivc wall.An intussusception is defined as telescoping of a hollow viscous inside of itself.This occurs along the long axis of viscous.There's is no evidence to suggest this type of deformity on image.Instead image is more consistent with at least 90 degrees of mid-and proximal filter twist upon attempted removal.When hock is twisted, filter should return to its original position unless wires have bent or legs have rotated along with proximal filter.In this case, no leg rotation occurred, so proximal filter wires must have bent while being twisted.Ivc appearance is more consistent with partial ivc wrapping around twisted filter.This would explain persistent stenosis rather than usual return to original position.A bent filter would also explain why angioplasty could only partially reduce stenosis.No evidence to suggest that this device was not manufactured according to specifications.This device is shipped with an instructions or use (ifu); which states that excessive force should not be used to retrieve the filter.The ifu also lists "acute damage to the inferior vena cava" as a possible adverse event.To evaluate the safety of retrieving the gunther tulip vena cava filter, a clinical study was conducted in which 41 patients were enrolled for possible retrieval of the filter.The results of this and other published and presented sources are listed in the ifu and demonstrate that the gunther tulip vena cava filter may be safely retrieved.The complaint device was not returned for inspection.Without more information on the patient anatomy and condition as well as dwell time of the device it is not possible to determine a root cause of this event.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), the addition of this complaint does not change the conclusion that further risk reduction is not required.

Event Description

As indicated in the journal article: "inferior vena cava filter retrieval: effectiveness and complications of routine and advanced techniques description according to article provided to cook: "inferior vena cava filter retrieval effectiveness and complications of routine and advanced techniques, ramsey al-hakim, md, j vasc interv radiol 2014": "the only complication associated with routine technique was an ivc intussusception (fig 1).The hook of the filter was snared without difficulty, but the sheath could not be fully advanced over the filter despite a large amount of tension.When tension was released, the filter legs were coapted, resulting in severe ivc stenosis, which was treated with intrafilter angioplasty, resulting in moderate ivc stenosis (sir major complication, grade c)." additional information regarding patient outcome was not provided.

• 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 ; 8123392235
• MDR Report Key: 4102584
• MDR Text Key: 4717373
• Report Number: 1820334-2014-00493
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: 09/10/2014; 09/10/2014
• Supplement Dates FDA Received: 06/19/2015; 10/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention