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

Catalog Number UNKNOWN

Device Problem Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

Brand name: although it was reported that the filter being removed was a gunther tulip ivc filter, we can not supply the full brand name without the access site for the filter placement.Pma/510(k) number = unavailable as the device lot number and catalog number is unknown.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.Medwatch#: mw5080206.(b)(4).

Event Description

The following event was initially reported via hhs/fda sus report reference: mw5080206.During an inferior vena cava (ivc) filter retrieval procedure, it was observed that a strut of the unspecified ivc filter had separated.It was reported that the patient has a history of a distant pulmonary embolism and high blood pressure, and is currently on anticoagulation therapy.For the retrieval procedure, access had been gained via the jugular vein.According to the customer representative, fluoroscopy determined that the legs of the complaint device were embedded in the wall of the patient's ivc, and a "laser" was used to cut them.A cook "tulip retrieval sheath and snare" were used to remove the complaint device, and no resistance was felt during this removal process.However, according to the report, "when the filter was removed and examined, it was noticed that a small piece of one of the struts was missing.[the physician] looked under [fluoroscopy], and the piece appeared embedded in the vessel wall." the embedded, separated strut was left inside the patient's anatomy.The customer representative reported that the patient's outcome, post-procedure, is "good" and "no issues" have been experienced.The customer representative reported that there is no catalog number or lot number available as it was not recorded during the initial insertion in 2006.The customer representative has confirmed that the complaint device will not be returned to the manufacturer for investigation and, although asked, it is unknown whether imaging, operative reports, pictures, and/or videos will provided.

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: a review of the complaint history, instructions for use (ifu), 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 provide studies demonstrating the günther tulip vena cava filter may be safely retrieved, but these studies were performed on patients with a max indwelling time of 475 days.The reported device indwelling time was 143 months, well beyond the mean days reported in these studies.Unsuccessfully retrieved devices were left in place as a permanent implant.Based on the information provided, no product returned and the results of our investigation, investigation has concluded that a definitive cause could not be established.However, they are convinced that this event cannot be traced to the device, and likely is due to the patient¿s condition as over a period of time, vena cava tissue will grow around the struts of the ivc filter making removal more challenging.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.[(b)(4)_hhs_fda_mw5080206_recvd 23oct2018_mnp.Pdf].

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8072457
• MDR Text Key: 127201875
• Report Number: 1820334-2018-03306
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• 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: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "TULIP RETRIEVAL SHEATH AND SNARE"
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 64