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

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Great Vessel Perforation (2152); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) number = k161218 (b)(4).Abstract complaint source reference: auyang, p., lumsden, a., bistmyth, j., bechara, c., (2018).Examining outcomes and causes of symptomatic long-term inferior vena cava filters, journal of vascular surgery, pp.E158-e159 this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.(b)(4).

Event Description

In the abstract authored by auyang et al.A review was completed of fifteen (15) patients of whom 3 patients received treatment with a cook inc.Bird's nest® vena cava filter.Three (3) female patients listed in the abstract each received a bird's nest® vena cava filter, and each patient experienced pain due to "strut protrusion outside the ivc and irritation of nearby structures, causing a variety of symptoms." the first female patient, age (b)(6), had the complaint device indwelling for 92 months.She allegedly experienced flank pain with symptoms occurring for 1 month total.It was found that the protruding struts of the bird's nest® vena cava filter through the inferior vena cava (ivc) were interacting with the anterior spine and the aorta.The device was retrieved via an open retrieval procedure (reference 1820334-2018-03893).The second female patient, age (b)(6), had the complaint device indwelling for 289 months.She allegedly experienced abdominal pain with symptoms occurring for 3 months total.It was found that the protruding struts of the bird's nest® vena cava filter through the inferior vena cava (ivc) were interacting with the renal vein, and retrohepatic ivc.The device was retrieved via an open retrieval procedure (reference 1820334-2018-03894).The third female patient, age (b)(6), had the complaint device indwelling for 185 months.She allegedly experienced abdominal pain with symptoms occurring for 1 month total.It was found that the protruding struts of the bird's nest® vena cava filter through the inferior vena cava (ivc) were interacting with the duodenum.The device was retrieved via an open retrieval procedure (reference this report 1820334-2018-03895).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A review of the complaint history, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, and specifications was 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.The device is shipped with instruction for use (ifu) which notes: contraindications, warnings, and precautions.The noted potential adverse events include, but are not limited to: filter migration (may occur if proper anchoring techniques are not utilized), inferior vena cava thrombosis, perforation of vena cava wall, and hematoma at puncture site.Furthermore, a review of the manufactures instructions , drawing, and quality control procedures was conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that this event falls under the known and inherent risk of this device.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.- attachment: [pr 248467_pr 248468_pr 248469_literature_auyang et al., 2018.Pdf].

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): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8203200
• MDR Text Key: 131704749
• Report Number: 1820334-2018-03895
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR