MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-UNI-TULIP

Device Problems Difficult or Delayed Positioning (1157); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the physician was doing a venous case, placing a wall stent in the renal vein.The balloon was inflated and the stent watermelon seeded off into the icv.The physician decided to place a gunther tulip navalign jugular and femoral vena cava filter to keep the stent from going into the heart.When he went to load the filter the feet would not load completely, it finally loaded but in an attempt to deploy the filter failed to open.The device was removed and another device was used to complete the procedure with no harm to the patient.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: investigation is based on description of event and returned product.The filter, blue sheath and long dilator was returned.The filter is symmetrical and leg width according to specifications.No imaging was provided and what caused the incident can not be explained by the returned.It is noted that there was no harm to the patient.However, the ifu states: "the günther tulip vena cava filter set is intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the following situations: ¿ pulmonary thromboembolism when anticoagulant therapy is contraindicated; ¿ failure of anticoagulant therapy in thromboembolic diseases; ¿ emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and ¿ chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated." the filter is not intended for prevention of a stent to migrate to the heart, why the filter placement in this complaint report is considered off-label-use.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the physician was doing a venous case, placing a wall stent in the renal vein.The balloon was inflated and the stent watermelon seeded off into the icv.The physician decided to place a gunther tulip navalign jugular & femoral vena cava filter to keep the stent from going into the heart.When he went to load the filter the feet would not load completely, it finally loaded but in an attempt to deploy the filter failed to open.The device was removed and another device was used to complete the procedure with no harm to the patient.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• 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: 5972544
• MDR Text Key: 55424268
• Report Number: 3002808486-2016-01116
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)161209(10)E3163582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• 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