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); Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.(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

Description of event according to short form complaint filed: it is alleged that "[pt] received a 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.

Event Description

Patient allegedly received an implant on (b)(6) 2012 via the right internal jugular vein post orthopedic surgery.Patient alleges tilt, vena cava perforation and migration.Patient further alleges to experience fast breathing, heart racing, becoming tired very fast.

Manufacturer Narrative

Corrected data: adverse event or product problem, type of reportable event.Additional information: age or date of birth, event, relevant tests/laboratory data, other relevant history.Patient code: vessels, perforation of (2135), listed in ifu.Palpitations (2467), not listed in ifu.Device code: unintended movement (3026) [device tilt], not listed in ifu.Migration or expulsion of device (1395).Appropriate term/code not available (3191) [device perforation], listed in ifu.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.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).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, or unavailable.Exemption number e2016032.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 - evaluation.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 ¿tulip - migration, tilt, vena cava and organ perforation, shortness of breath, tiredness".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.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.Unknown if the reported shortness of breath is directly related to the filter.Unknown if the reported tiredness is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot# are unknown, but filter 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.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

No additional information provided at this time.

Manufacturer Narrative

Corrected information: a3 (gender).Additional information: investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.The catalog # and lot # are unknown, but the 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.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.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

Report from ct (computed tomography): "filter type: cook gunther tulip.Ivc stenosis: no.Filter position: partially above the level of the renal veins.Impressions: half of the filter is above the renal veins.The body of the filter crosses over the osmium of both renal veins.It may have been placed high or may have migrated to this position.A high position of the filter puts the patient at risk for renal vein thrombosis and renal failure if the ivc becomes thromboses.The filter is tilted to the left with its proximal cone against the ivc wall.Axial image 63.The anterior right strut penetrates 12 mm through the ivc wall.The anterior left strut penetrates 6 mm through the ivc wall.The posterior right strut penetrates 9 mm through the ivc wall.The posterior left strut penetrates 3 mm through the ivc wall.".

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov DK-46 32; DA DK-4632
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7998972
• MDR Text Key: 124803766
• Report Number: 3002808486-2018-01241
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/17/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/09/2018
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 11/30/2018; 12/11/2018; 03/01/2023
• Supplement Dates FDA Received: 12/07/2018; 12/19/2018; 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening
• Patient Sex: Male
• Patient Weight: 76 KG