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 Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Death (1802); Septic Shock (2068)

Event Date 06/23/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to study: patient was consented in preserve and had the günther-tulip¿ vena cava filter system successfully placed on (b)(6) 2017.On (b)(6) 2017 subject reported getting out of bed and falling.He remained on the ground for approximately 3-4 hours prior to his son taking him to the emergency department for further evaluation.In the ed, it was noted that his blood pressures were low at 94/46 with maps in the 50s.Initial venous lactate came back at 4.59 and code sepsis was initiated.Medical icu was consulted for further management of shock in this immunosuppressed subject.In the emergency department, subject's pressures were noted to be low with maps in the 50s.He was resuscitated a total of 3000 ml lr and started on levophed for pressure support.His oxygen status was adequate with 100% o2 on 4 liters nasal cannula.Initial laboratory did reveal white blood cell count less than 0.1, hemoglobin 8.5, and platelets of 37.Of note, his bnp was 2562 and troponin of 0.02.Venous lactate originally 4.59 with subsequent draw 5.13.Blood cultures were drawn and subject was started on empiric antibiotics with vancomycin and meropenem.He expired at 18:07 on (b)(6) 2017.This event was considered possibly related to the device." patient outcome: patient died (b)(6) 2017.

Manufacturer Narrative

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

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of (b)(4) (importer).Manufacturer ref# (b)(4).After investigation the event for this pr# is no longer reportable name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and image review.Approximately 4 months after filter placement the patient had a fall and was brought to emergency room with elevated lactate and hypotension where code sepsis was initiated.Patient started treatment, but died on the same day.Diagnostic examinations performed after the fall demonstrate no acute abnormalities.The gunther tulip ivc filter is partially imaged on the studies and does demonstrate an insignificant rightward tilt but is otherwise unremarkable.A chest ct was performed without iv contrast, so evaluation of pulmonary embolism is not possible.There are no secondary findings of pulmonary embolism such as right heart strain.The gunther tulip ivc filter is imaged on one additional kub (for kidneys, ureters, and urinary bladder) which demonstrates stable configuration with persistent rightward tilt.Subsequent chest x-rays continued demonstrate progressive consolidation at the left lung base.Per the complaint report, patient was started on broad spectrum antibiotics as well as volume resuscitation with levophed but expired four days later from cardiopulmonary arrest.The patients labs did demonstrate a white blood count of less than 0.1 with thrombocytopenia and anemia, all related to his myelodysplastic syndrome.Nothing on the images, nor in the clinical history provided would suggest that the patient's demise was related to the ivc filter, but more direct cause of the patient's underlying medical condition and sepsis in the setting of severe leukopenia.The patient did have a peripherally inserted central catheter in place prior to clinical demise and sepsis related to the central venous catheter would be exponentially more probable.No evidence to suggest that this tulip filter was not manufactured according to specifications and nothing indicates that it 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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8149705
• MDR Text Key: 129871934
• Report Number: 3002808486-2018-01435
• 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: study
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E3536252
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/21/2018
• Device Age: 5 MO
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR