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

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problems Embolus (1830); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Common name = unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.(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

A journal article was reviewed, "retrievable inferior vena cava filters can always be removed using 'fall-back' techniques", which detailed a retrospective chart review study conducted of data which was collected of all patients undergoing inferior vena cava filter (ivcf) removal by vascular surgeons at a tertiary academic medical center between 2009 and 2013 including demographics and procedural and filter characteristics.The study objective was to analyze how incorporation of new 'fall back' techniques for filter retrieval which were unsuccessful using standard snaring techniques, affected the outcomes of ivcf retrievals in patients with retrievable ivcf left in place for a prolonged period.The study concluded incorporation of fall back techniques may allow 100% technically successful and safe removal of retrievable ivcfs and is especially useful in removing filters with prolonged dwell time.According to the journal article, during attempted filter retrieval using 'lasso' technique, there were four complications.All occurred with the retrieval of gunther tulip filters by the lasso fallback technique.Three cases involved embolization of fractured bentson wires to the right atrium or pulmonary artery.In one case, a strut of a filter fractured and was left embedded in the caval wall.In all four cases, embolized and retained fragments were successfully snared endovascularly without long-term consequences.Specific procedural, product, and lot number information was not provided.This report is for the fractured filter strut.Please reference medwatches: 1820334-2019-00727; 1820334-2019-00729; and 1820334-2019-00730 for the reports of the fractured wires.Citation: etkin, y., glaser, j.D., nation, d.A., foley, p.J., wang, g.J., woo, e.Y.,.Jackson, b.M.(2015).Retrievable inferior vena cava filters can always be removed using ¿fall-back¿ techniques.Journal of vascular surgery: venous and lymphatic disorders, 3(4), 364-369.Doi:10.1016/j.Jvsv.2015.04.002.

Event Description

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

Manufacturer Narrative

Investigation - evaluation: reviews of the complaint history and specifications of the device as well as a clinical assessment were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Furthermore, while the lot was not provided, the ifu for the i-gtcfs-339-04en states that ¿excessive force should not be exerted to retrieve the filter¿.In addition, the ifu states that the gunther tulip filter is designed to be retrieved with the gunther tulip vena cava filter retrieval set; and may also be retrieved with the cloversnare vascular retriever.The ifu clearly states: ¿cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques¿.In addition, the ifu states that the safety and effectiveness of alternative retrieval techniques ¿has not been established¿.Based on the information provided and no product returned, investigation has concluded that no cause could be established for the device failure.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8467316
• MDR Text Key: 140490438
• Report Number: 1820334-2019-00728
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• 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
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention