MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G33017

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation (2001); Thrombus (2101); Chest Tightness/Pressure (2463)

Event Type  Injury  

Manufacturer Narrative

William cook (b)(4) initially reported event under mfr report #3002808486-2017-01118.New information was received identifying that the product was a cook inc.Manufactured device.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012 due to a thromboembolic disease.Patient alleges an attempted retrieval occurred on (b)(6) 2012, however the procedure was aborted due to a blood clot on the filter.Patient further alleges to feel stiffness on her chest.

Manufacturer Narrative

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 'thrombus on filter (ivc occlusion) + chest stiffness (potential pe), unable to retrieve'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.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

(b)(4).Additional information: investigation: the following allegations have been investigated: organ perforation, embedded, tilt 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Product is manufactured, inspected and packaged by william cook europe (b)(4).

Event Description

Patient alleges caval thrombus.As per a ct scan performed on (b)(6) 2014, it states "posterior tilt of the inferior vena cava filter with the hooks embedded in the caval wall." as per a ct scan performed on (b)(6) 2017, it states "positive for caval perforation.Five prongs have perforated the ivc.Two prongs have perforated duodenum.4-degree tilt ivc filter from right to left.".

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7114051
• MDR Text Key: 95081339
• Report Number: 1820334-2017-04471
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)150101(10)3105184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Model Number: G33017
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 3105184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2019
• Date Device Manufactured: 01/01/2012
• 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: 63 YR
• Patient Weight: 77