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

Catalog Number IGTCFS-65-FEM

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Type  Death  

Manufacturer Narrative

Reporter occupation: non-healthcare professional.Investigation: the reported allegations have been investigated based on the information provided to date.Unknown if the reported death is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.The alleged tulip 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 medwatch report will be submitted if additional relevant information becomes available.

Event Description

It is alleged that the patient received a gunther tulip on (b)(6) 2009, and the patient subsequently expired as a result using the filter.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received, an implant on (b)(6) 2009 via the right groin, due to submassive pulmonary embolism.Patient is alleging death, vena cava perforation, bleeding.Further alleges, physical suffering, emotional suffering, internal bleeding, physical limitations.Per certificate of death dated (b)(6) 2019, "immediate cause: hemoperitoneum, due to or as a consequence of inferior vena cava perforation by ivc filter".

Manufacturer Narrative

Additional information: investigation.The following allegations have been investigated.Vena cava (vc) perforation, internal bleeding, physical suffering, emotional suffering, physical limitations.Investigation is reopened, due to additional information provided.The reported allegations have been further investigated, based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment, and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Unknown if the reported, internal bleeding, physical suffering, emotional suffering, and physical limitations are directly related to the filter.And unable to identify a corresponding failure mode at this point in time.A total of 20 devices were manufactured in the reported lot.To date, no other complaints have 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 current controls 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 medwatch report will be submitted, if additional relevant information become available.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.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10620100
• MDR Text Key: 209590881
• Report Number: 1820334-2020-01802
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2012
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2345777
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 88