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

Model Number N/A

Device Problems Device, or device fragments remain in patient (1527); Difficult to Remove (1528)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 01/19/2007

Event Type  malfunction  

Event Description

Info was provided to cook via lawsuit.Cook received notice via (b)(6) the complainant alleges.It is alleged that on or about (b)(6), 2006, the pt presented and was diagnosed with thrombus of the inferior vena cava (ivc).It was diagnosed that she would be implanted with a gunther tulip vena cava filter on (b)(6), 2006, without complication, following a diagnosis of deep vein thrombosis.On or about (b)(6), 2006, the pt was evaluated for removal of the device but it was determined that "embolic risk" was still present and thus the filter was left in place.On or about (b)(6), 2007, the pt presented for filter removal.It was determined "under fluoroscopic control that the filter struts had been incorporated by the endothelium" and the decision was made that since the filter was very secure in its current position the decision was made to end the procedure and leave the filter permanently.The pt was placed on permanent vascular follow up and chronic anticoagulation with coumadin.It is alleged that one or about (b)(6), 2013 a ct scan showed the filter had "multi-focal leg penetration" and it was at this time the pt discovered the "cause of her injuries." on or about (b)(6), 2013, the pt presented herself to a hosp complaining of right-side abdominal pain and underwent a "complex retrieval of the filter.".

Manufacturer Narrative

Expiration date unk as lot # is unk.(b)(4).Event is still under investigation.

Manufacturer Narrative

(b)(4).Corrected data based on new information received: adverse event or problem: adverse event to product problem, type of reportable event: serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 04/15/2015 and is as follows: patient alleges that a cook gunther tulip filter was placed on (b)(6) 2006 for ivc thrombosis.Patient alleges that outcomes attributed to the device include: vena cava perforation.Patient records also allege that the patient complained of right abdominal pain, whereby imaging showed multifocal leg penetration through the caval wall and a chronically embedded filter.Patient alleges two attempts to retrieve the device.The first attempt ((b)(6) 2007) was unsuccessful.The second attempt ((b)(6) 2013) was successful.This attempt, via the right jugular vein, was alleged to be a complex retrieval.

Manufacturer Narrative

Correction(s): adverse event or product problem: from product problem to adverse event and product malfunction.Type of reportable event: from malfunction to serious injury.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'vena cava perforation, difficult retrieval '.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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.There is 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.

Manufacturer Narrative

Correction(s): from serious injury to malfunction.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'vena cava perforation, embedded, difficult to remove, abdominal pain".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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.Unknown if the reported abdominal pain is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Product is manufactured and inspected according to manufacturing instructions and quality control.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.

Manufacturer Narrative

Investigation- evaluation: a review of the complaint history, instructions for use (ifu), manufacturing instructions (mi), quality control (qc), specifications and trends was conducted for the purpose of this investigation.Evaluation is based on event description, since no device, medical records or imaging are available at the moment.It is alleged that on (b)(6) 2006, the patient was implanted with a gunther tulip vena cava filter, without complication, following a diagnosis of deep vein thrombosis.On (b)(6) 2006, the patient was evaluated for removal of the device but it was determined that "embolic risk" was still present and thus the filter was left in place.On (b)(6) 2007, it was determined "under fluoroscopic control that the filter struts had been incorporated by the endothelium" and the decisions was made to end the procedure and leave the filter in permanently.It is alleged that on (b)(6) 2013 a ct scan showed the filter had "multi-focal leg penetration" and it was at this time the patient discovered the "cause of her injuries".On (b)(6) 2013, the patient presented herself to a hospital complaining of right-side abdominal pain and underwent a "complex retrieval of the filter." no further location detail or information concerning the patient's current condition is provided.In this specific case the catalog and lot number are unknown, however, the tulip filter is manufactured and inspected.No evidence to suggest that this device was not manufactured according to specifications.Filter perforation of the vena cava wall is a well known risk in the literature.However, the exact root cause for what caused the filter perforation is unknown.As no device, imaging studies or hospital/medical records have been available, the investigation is limited to the allegations in the lawsuit.Consequently, based on very limited information it is difficult to comment on the alleged filter perforation and abdominal pain.We are unable to determine the root cause based on the limited information provided.

Event Description

Information was provided to cook via lawsuit.Cook received notice via (b)(6).The complaint alleges: it is alleged that on or about (b)(6) 2006, the patient presented and was diagnosed with thrombus of the inferior vena cava (ivc).It was determined that she would be implanted with a gunther tulip vena cava filter on (b)(6) 2006, without complication, following a diagnosis of deep vein thrombosis.On or about (b)(6) 2006, the patient was evaluated for removal of the device but it was determined that "embolic risk" was still present and thus the filter was left in place.On or about (b)(6) 2007, the patient presented for filter removal it was determined "under fluoroscopic control that the filter struts had been incorporated by the endothelium" and the decision was made that since the filter was very secure in its current position the decision was made to end the procedure and leave the filter in permanently.The patient was placed on permanent vascular follow-up and chronic anticoagulation with coumadin.It is alleged that on or about (b)(6) 2013 a ct scan showed the filter had "multi-focal leg penetration" and it was at this time the patient discovered the "cause of her injuries".On or about (b)(6) 2013, the patient presented herself to a hospital complaining of right-side abdominal pain and underwent a "complex retrieval of the filter".No further location detail or information concerning the patient's current condition has been provided.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4009394
• MDR Text Key: 4706212
• Report Number: 1820334-2014-00334
• 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,consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/30/2014,11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Distributor Facility Aware Date: 07/03/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/19/2017
• 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): Required Intervention
• Patient Age: 20 YR