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

Catalog Number UNKNOWN

Device Problem Inadequate Filtration Process (2308)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Paralysis (1997); Partial Hearing Loss (4472)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (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.Pma/510(k): 172557.Corrected data compared with medwatch report mw5100828.Product problem and adverse event.(b)(6) 2014.William cook europe.(b)(6) 2013.Device available for evaluation.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "on (b)(6) 2010, i had a cook gunther tulip ivc filter placed.From 2011 to 2013 i had several pulmonary embolisms some which caused a small stroke, loss of hearing in my right ear.I also had seizures, and temporarily i had paralysis on my left side.In 2013, i had a surgery because clots were traveling in my body.I asked why this happened when i have a filter to prevent this from happening.In 2014 when i asked for the manufacturer and for medical device info, i was told there wasn't any documentation or labeling product id or the company and type of filter.In 2021 i received a voicemail from my primary doctor, that the filter i had was a cook gunther tulip filter, but that there are no other records just the verbal one which i asked for in writing and that was denied.They assured me that there aren't any recalls documented with this type of ivc filter.I don't want anyone else suffering like i have, so i wanted to notify whoever about my complications and adverse side effects from the cook gunther tulip ivc filter.Concomitant medical products: kidney stents, ivc filter, reaction arixtra shots, iron, one a day vitamin".

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: the filter was placed in 2010 and one to three years after filter placement the patient allegedly had several pulmonary embolisms.There is no information as to filter removal.The tulip filter was not returned and no imaging nor the patient¿s medical records were provided.Therefore, based on the very limited information provided the exact reason for the ¿several pulmonary embolisms¿ experienced in the period between one and three years after placement of the filter cannot be determined.Nor can the reason for the alleged small stroke, loss of hearing, and temporarily paralysis, but assuming normal anatomy in the cardiovascular system it is considered unlikely that an embolus/embolic material from the filter would travel from the venous side to the arterial side.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Cook medical will continue to monitor for similar events.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 11875406
• MDR Text Key: 254528387
• Report Number: 3002808486-2021-01266
• 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
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1