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

Model Number N/A

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Anxiety (2328); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

William cook (b)(4) initially reported event under mfr report # 3002808486-2016-00210.New information was received identifying that the product was a cook inc.Manufactured device.Cook is now submitting an initial report under mfr report # 1820334-2016-00782.Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Evaluation- the product was not returned to assist with the investigation.No information regarding the event was provided.No notes of relevance found in the device work order, nor on the filter lot number.No other complaints have been received relevant to this lot.Impossible to comment on the alleged injuries.Device manufactured/inspected according to specifications.There is no evidence to suggest the device was not manufactured to specifications.No evidence to suggest a device failure.We have notified appropriate personnel and will continue to monitor for similar events.If additional information is received, the report will be reopened for further investigation.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2013 at (b)(6) hospital".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).Corrected data based on new information received: adverse event to product problem, serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 05/13/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2013 due to deep vein thrombosis.Plaintiff is alleging tilt, embedment, unable to be retrieved, anxiety.Plaintiff alleges attempted retrieval in (b)(6) 2013 but did not provide specific date.

Manufacturer Narrative

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 ¿tilt, embedment, unable to be retrieved, anxiety".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.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.It is unknown if the reported anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.There is 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

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.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.

Event Description

Per ir venogram (attempted retrieval), dated 01oct2013, "extensive attempts were made to remove the ivc filter.Despite the extensive attempts, the filter could not be safely removed.The filter was left in place.".

Event Description

No additional information has been provided at this time.

Manufacturer Narrative

Additional information: investigation.The investigation was 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 "unable to retrieve, tilt, embedment, anxiety." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.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.A filter that is embedded in the wall of the ivc (inferior vena cava) may be difficult to retrieve.Unknown if the reported anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.No other complaints on lot.Product 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.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 JUGULAR 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: 6202431
• MDR Text Key: 63219157
• Report Number: 1820334-2016-00782
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)160701(10)4425119
• Combination Product (y/n): N
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 4425119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 119