MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Arrhythmia (1721); Dyspnea (1816); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook gunther tulip filter.(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

It is alleged that "patient received a gunther tulip filter on (b)(6) 2011".It is alleged that patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number e2016032.(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

This additional information received on 22mar2018 as follows: ¿[pt] allegedly received an implant on (b)(6) 2011 via the right common femoral vein due to pulmonary embolism and deep vein thrombosis.[pt] is alleging migration, tilt, embedded filter.[pt] further alleges tightness in chest/pressure, irregular heartbeat and shortness of breath.Filter was successfully retrieved on (b)(6) 2017.

Manufacturer Narrative

Exemption number e2016032e william cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.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 "tulip-migration, tilt, embedded (difficult retrieval), chest pain, irregular heartbeat, shortness of breath¿.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.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.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.Unknown if the reported chest pain and shortness of breath are directly related to the filter.Rpn and lot# are unknown, but the tulip filter 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.H3 other text : blank fields on this form indicate the information is unknown or unavailable, or unchanged.Exemption number e2016032e william cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.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 "tulip-migration, tilt, embedded (difficult retrieval), chest pain, irregular heartbeat, shortness of breath¿.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.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.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.Unknown if the reported chest pain and shortness of breath are directly related to the filter.Rpn and lot# are unknown, but the tulip filter 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: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7394981
• MDR Text Key: 104250433
• Report Number: 3002808486-2018-00413
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/21/2018
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 04/27/2018
• Supplement Dates FDA Received: 04/18/2018; 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 66