MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G21360

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Cramp(s) (2193); Numbness (2415)

Event Type  malfunction  

Manufacturer Narrative

The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2019-00874.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial report, cook inc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in this initial medwatch report.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Occupation: non-healthcare professional.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

Patient allegedly received an implants on (b)(6) 2014 and (b)(6) 2014.Patient is alleging "i have pain in both legs, cramps, numbness.I have to elevate my legs all the time to feel better".This report is for the implant placed on (b)(6) 2014.The implant placed (b)(6) 2014 will be reported separately.

Event Description

No additional information provided at this time.

Manufacturer Narrative

Additional information: the following field was updated per additional information received: h6.Investigation ¿ investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: multiple deep vein thrombosis, pain, cramps and numbness in legs.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported pain, cramps and numbness in legs is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of fourteen (14) devices were manufactured in the reported lot.To date, no other complaints have been reported against this lot.The associated work order was reviewed.No related/relevant notes were documented.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b6, b7.H6 conclusion code(s): appropriate term/code not available (4316) was selected because the previous investigation remains unchanged by the additional information.Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new additional information received at this time.

• Brand Name: GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9126334
• MDR Text Key: 176456731
• Report Number: 1820334-2019-02437
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)160601(10)5070202
• Combination Product (y/n): N
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: G21360
• Device Catalogue Number: IGTCFS-65-UNI
• Device Lot Number: 5070202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 61