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

Model Number N/A

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2003 at (b)(6).¿ it is alleged that patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2003 at (b)(6).¿ it is alleged that patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Unknown if the following patient and device codes are listed in the ifu.Product information not provided.(b)(4).Corrected selection from adverse event to product problem to match parent and based on documentation provided by plaintiff's attorney.Corrected selection from serious injury to malfunction to match parent and based on documentation provided by plaintiff's attorney.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 04/27/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2003 via the jugular vein due to risk for dvt and pe preoperative to gastric bypass surgery.Plaintiff is alleging device tilt, device is unable to be retrieved, and she feels it moving.

Manufacturer Narrative

Investigation evaluation: it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿tilt, device is unable to be retrieved, feel it moving".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.It is unknown if the reported ability to feel the device moving is directly related to the filter and a failure mode cannot be identified at this point in time.

• 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 ; 8123392235
• MDR Report Key: 6131530
• MDR Text Key: 61019600
• Report Number: 1820334-2016-01421
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Distributor Facility Aware Date: 11/08/2016
• Date Manufacturer Received: 08/10/2017
• 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): Other
• Patient Weight: 141