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

Catalog Number IGTCFS-65-JUG

Device Problems Inadequate Filtration Process (2308); Structural Problem (2506); Device Tipped Over (2589); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135); Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

William cook europe initially reported event under mfr report #3002808486-2017-01909.New information was received identifying that the product was a cook inc.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

Patient received an implant on (b)(6) 2010 due to post-op hysterectomy pulmonary embolism, deep vein thrombosis.Patient is alleging subsequent pe, shortness of breath, strength issues without further details.

Manufacturer Narrative

Investigation is reopened due to additional information provided.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 'subsequent pe, shortness of breath, strength issues'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Unknown if the reported shortness of breath and strength issues are directly related to the filter and unable to identify corresponding failure mode(s) at this time.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: bleeding, tilt, organ perforation, embedded.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.Update - cinc: product specification spec_91890 gives instructions pertaining to this device.The specification states, "product is manufactured, inspected and packaged by william cook europe (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Patient alleges bleeding (cat form).As per a ct scan performed on (b)(6) 2017 it is stated, " ivc filter is tilted rightward and posteriorly.Perforation of the anterior strut into the 2nd portion of the duodenum.Perforation of the posterior strut embedded in the t3 vertebral body.Perforation of the medial strut into the aortocaval space.".

Manufacturer Narrative

Corrected information: a3 (gender).Additional information: b5, b6, h6 (patient code e0511 and device code a0511).Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava perforation.The additional information regarding vena cava perforation does not change the previous investigation results for organ perforation.20 devices in lot.To date, one other complaint for a different issue has been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.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.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Per a medical opinion regarding a computed tomography (ct) scan dated (b)(6) 2021: "ivc filter is infrarenal in position.The anterolateral filter strut is seen piercing the respective wall of ivc and is lying adjacent to the duodenum (8.75mm).The posterolateral filter strut is seen piercing the respective wall of ivc (13.10 mm).The anteromedial filter strut of ivc is seen piercing the respective wall of ivc (11.42 mm) and is lying adjacent to the duodenum.The posteromedial filter strut is seen piercing the respective wall of ivc (22.87 mm) and pierces the prevertebral structures, and likely a small zone of osteolysis surrounding the penetrated strut is seen into the l3 vertebral body.The filter head is tilted postero-laterally by an angle of 24.46 degree and appears to be tenting noted.No tilt of the ivc filter is noted.No ivc filter fracture noted".

• 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: 6966079
• MDR Text Key: 89886496
• Report Number: 1820334-2017-03695
• Device Sequence Number: 1
• Product Code: DTK
• 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,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 2548846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• Date Device Manufactured: 07/29/2010
• 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
• Treatment: N/A.
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Weight: 64 KG