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

Model Number N/A

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problems Liver Damage/Dysfunction (1954); Pulmonary Dysfunction (2019)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported device is not available for evaluation and has been discarded.

Event Description

It was reported by the patient that a gunther tulip was implanted in 2009 while they were comatose.In spite of a statement that it was unreported and undocumented, the patient listed the implant date as (b)(6) 2009.The patient stated that it was discovered in their body in 2014.The patient stated that the device caused pain and the device was removed in 2015.The explant date was reported to be (b)(6) 2015.The patient stated that they had post surgery complications that were ignored that lead to the shut down of their liver.The patient states that ¿my vena cava is damaged and oxygenated blood is not circulating in my body¿.The patient stated that they were ¿a very healthy female prior to needing an ivc filter¿.The patient further stated, ¿i spent a year in bed after surgery once i made the attempt to resume my life and work the symptoms started.¿ further comments made by the patient on the sus voluntary report were, ¿ very hard to diagnose when the acting physician redacts and fails to forward and disclose events of past ct¿s and reports.¿ she stated she was ¿mocked if you will as over reactive.¿ she stated the physician said that the ¿symptoms in his interpretation are not related to device less than never addressing the device as the gunther tulip retrievable ivc filter, but constant statements of patient statements are not contributory.¿ the patient also stated, ¿now near incapacitated.¿ she stated she ¿switched health care providers and that the new medical team has diagnosed pulmonary hypertension- damaged vena cava post ivc filter removal.¿ the patient also stated, ¿incurable progressive i am 2 years into a 3 year life prognosis.What would have been prevented if the concealment of relative changes in my body were pro acted upon.I just received this diagnosis 3 weeks ago.¿.

Manufacturer Narrative

Investigation - evaluation : a review of the complaint history and specifications was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.The complainant device lot number is unknown.Thus, a review of the device history record, nonconformance history, and related product complaints query could not be conducted.However, there is no evidence to suggest the finished product was not made 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.It is noted that according to health care professionals the patient's symptoms were not related to the device "less than never addressing the device as the gunther tulip retrievable ivc filter".The reason for the filter fracture cannot be determined, but based on information provided it is assumed that the fractured filter legs were surgically removed.The investigation will be reopened, in case additional information is provided.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.Based on the information provided, no product returned and no images provided, and the results of our investigation; a definitive root cause could not be determined.Per the risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6712213
• MDR Text Key: 80010759
• Report Number: 1820334-2017-01637
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention