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

Catalog Number UNKNOWN

Device Problems Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation of Vessels (2135); Anxiety (2328); Palpitations (2467); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a cook gunther tulip filter.Name and address for importer site: (b)(4).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 ¿celect filter implanted".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2012".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

Exemption number: e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Mfr site: name and address for importer site: (b)(4).Additional information: investigation: 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 "gunther tulip-tilt, vc perforation, unable to retrieve, embedment, anxiety, irregular heartbeat" cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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.Unknown if the reported anxiety, irregular heartbeat is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Tulip filter is manufactured and inspected according to manufacturing instructions and quality control.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.

Event Description

This additional information received on 16mar2018 as follows: ¿[pt] allegedly received an implant on (b)(6) 2012 via the right common femoral vein due to acute deep vein thrombosis and bilateral pulmonary embolism.[pt] is alleging tilt, vena cava perforation, device unable to be retrieved, endothelium covering several of the struts.[pt] further alleges tines of the filter extended outside the ivc wall by up to 8 mm, retrieval impossible, lifelong monitoring, anxiety.Per additional information [pt] experiences unsteady heartbeat.Filter retrieval was attempted on (b)(6)2012.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of (b)(6) (importer).Patient code: vessels, perforation of (2135) listed in the ifu, palpitations (2467) not listed in the ifu, anxiety (2328) not listed in the ifu device code: no code available (3191) no code for device perforation listed in the ifu, unintended movement (3026) (tilt) not listed in the ifu, difficult to remove (1528) listed in the ifu.Name and address for importer site: (b)(6).Registration no.: (b)(4).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.

• 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: 7276005
• MDR Text Key: 100239524
• Report Number: 3002808486-2018-00254
• 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: 05/10/2018

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: 02/06/2018
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/16/2018; 04/19/2018
• Supplement Dates FDA Received: 04/12/2018; 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 109