MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problem Occlusion Within Device (1423)

Patient Problem Edema (1820)

Event Date 02/01/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: patient underwent a filter implant (b)(6) 2015.Mild edema was observed (b)(6) 2015(exact date when edema started:unknown).Blood clots around the filter and in the pulmonary artery were confirmed (b)(6) 2015.Heparin was infused to dissolve the blood clots.Filter retrieval was planned (b)(6) 2015, but was cancelled due to the condition did not improve.On (b)(6) 2015 the condition was improved to the extend where filter retrieval was possible.The filter was then removed with success.No additional information could be obtained and without imaging it is difficult to comment on the reported occlusion, but based on information provided there is no evidence to suggest that the günther tulip filter 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.Manufacturer ref# (b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: patient underwent a filter implant (b)(6) 2015.Mild edema was observed (b)(6) 2015(exact date when edema started:unknown).Blood clots around the filter and in the pulmonary artery were confirmed (b)(6) 2015.Heparin was infused to disolve the blood clots.Filter retrieval was planned (b)(6) 2015, but was cancelled due to the condition did not improve.On (b)(6) 2015 the condition was improved to the extend where filter retrieval was possible.The filter was then removed with success.No additional information could be obtained and without imaging it is difficult to comment on the reported occlusion, but based on information provided there is no evidence to suggest that the günther tulip filter 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.

Event Description

Description of event according to initial reporter: on (b)(6) 2015: a male patient was diagnosed as suffering from dvt and thus, the complaint filter was placed in the ivc.From that day on, systemic administration of urokinase 240000 unit/day and heparin 800 unit/hour from right brachial vein was started.On (b)(6) 2015: although mild edema had been already observed on the patient by this day, the condition of the edema worsened further.Therefore, the medication of the systemic administration was changed to urokinase 120000 unit/day and heparin 1400 unit/hour and wait-and-see approach was taken.On (b)(6) 2015: as edema did not improve, cta was conducted, through which blood clots around the filter and in the pulmonary artery were confirmed.Thus, proper amount of t-pa for a man weighing 85kg and heparin 1600 unit were infused so as to dissolve the blood clots.On (b)(6) 2015: since filter retrieval was planned to be performed on this day, angiography from the left femoral artery was conducted, through which total occlusion of the ivc below the filter was confirmed.Although urokinase 60000 unit was infused through an infusion catheter (fountain catheter), the condition did not improve.Therefore, filter retrieval was cancelled and the filter remained placed in the ivc as-it-was.The physician determined to monitor the patient while leaving the infusion catheter in the body and administrating urokinase 60000 continuously through it.He plans to perform filter retrieval in the future, but when to perform has not been determined yet.Additional information received (b)(6) 2015: on (b)(6) 2015: since the fountain catheter almost slipped out of the body, a cv (central venous) catheter was placed alternatively.In addition, as the physician thought the blood clots would not be dissolved enough only with one directional infusion, another cv catheter was also placed from right femoral vein.On (b)(6) 2015: since the condition of the edema in lower limb was getting better, angiography was performed, which confirmed that the blood clots had decreased to a large extent.And therefore, filter retrieval was determined to be performed on that day.After another manufacturer's filter (new house protect /toray medical) was placed by left jugular approach, the complaint filter was retrieved from right jugular vein successfully.Although there still remains a few blood clots in ivc, the physician supposes that these clots will be dissolved without problems because the blood flow of the patient's has been already improved.Patient outcome: despite severe edema, there is no threat to his life.

• Brand Name: GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6265843
• MDR Text Key: 65345837
• Report Number: 3002808486-2017-00009
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)160709(10)E3109189
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 01/20/2017
• Date Device Manufactured: 07/09/2013
• 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 Age: 43 YR
• Patient Weight: 85