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

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Renal Failure (2041)

Event Type  Death  

Manufacturer Narrative

Date of death is unknown however the article list ¿time of occurrence¿ the time frame is documented in describe event or problem.(b)(4).The event is currently under investigation.

Event Description

Mohan, chittur r.Md, et.Al: comparative efficacy and complications of vena caval filters journal of vascular surgery, february 1995; 21; 235-246.The above referenced journal article alleged that 4 patients implanted with bird's nest filters [bnfs) died as a result of occlusion complications resulting in kidney failure.The patients were identified in table iv as the potential patients, through analysis of the twelve patients listed in the table: reportedly in the bnf group with symptomatic ivc thrombosis, the clinical presentation was acute renal failure as a result of extension of thrombosis into the renal veins.All four patients who had development of acute renal failure were treated without operation and died as a result of renal failure.No information regarding date of events, procedures or patient information were provided.

Manufacturer Narrative

(b)(4).Product has not been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.(b)(4).

Event Description

Mohan, chittur r.Md, et.Al: comparative efficacy and complications of vena caval filters journal of vascular surgery, february 1995; 21; 235-246.The above referenced journal article alleged that 4 patients implanted with bird's nest filters [bnfs) died as a result of occlusion complications resulting in kidney failure.The patients were identified in table iv as the potential patients, through analysis of the twelve patients listed in the table : reportedly in the bnf group with symptomatic ivc thrombosis, the clinical presentation was acute renal failure as a result of extension of thrombosis into the renal veins.All four patients who had development of acute renal failure were treated without operation and died as a result of renal failure.No information regarding date of events, procedures or patient information were provided.

Manufacturer Narrative

Investigation - evaluation.A review of the complaint history, drawings, instructions for use (ifu), manufacturing instructions and quality control 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 correct gauge of the barbed cannula is inspected.The product is inspected for 100% verification of length, position, spacing and bevel type of the barbs.The product is shipped with an ifu which lists the anatomical requirements, contraindications, warnings and precautions, and correct deployment procedure.The exact ifu is dependent on product size and placement approach.Without the exact device product code, we cannot determine the exact ifu.However, in each ifu contains the following warning: ¿the bird¿s nest vena cava filter is non-thrombogenic, but may occlude if it traps a large volume of embolic material in a short time period.Thrombolytic agents administered via femoral venipunctures have been successful in re-establishing filter and caval patency.¿ the ifu also includes a list of potential adverse events.Vena cava occlusion and thrombosis are listed among the potential adverse events.The lot number of the device is not known, accordingly a review of the device manufacturing records could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5853959
• MDR Text Key: 51387626
• Report Number: 1820334-2016-00840
• 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: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/08/2016; 01/11/2017; 06/19/2017
• 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): Death