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

Model Number N/A

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anxiety (2328); No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information was previously submitted by william cook europe under reference # 3002808486-2016-00645 on 07jul2016.Additional lot information provided on 09nov2016 determined this device was manufactured by cinc.Evaluation- the product was not returned to assist with the investigation.No information regarding the event was provided.No notes of relevance found in the device work order, nor on the filter lot number.No other complaints have been received relevant to this lot.Impossible to comment on the alleged injuries.Device manufactured/inspected according to specifications.There is no evidence to suggest the device was not manufactured to specifications.No evidence to suggest a device failure.We have notified appropriate personnel and will continue to monitor for similar events.If additional information is received, the report will be reopened for further investigation.

Event Description

It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2015 at (b)(6) in (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

(b)(4).Corrected data based on new information received: adverse event to product problem.Serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 07/25/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the right internal jugular vein due to post trauma, pelvic fracture and had an attempted retrieval (unsuccessful) performed on (b)(6) 2015.Retrieval notes described the attempt as unsuccessful because 'the attachments of the struts to the caval wall could not be overcome.' plaintiff is alleging device is unable to be retrieved, anxiety.

Manufacturer Narrative

Additional information: 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 "tulip, device is unable to be retrieved, other: anxiety".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.It is unknown if the reported anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.There is 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.

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• 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: 6137883
• MDR Text Key: 61229228
• Report Number: 1820334-2016-01398
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)171001(10)5434919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• 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
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• 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: IGTCFS-65-JUG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2017
• Date Device Manufactured: 11/14/2014
• 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 Age: 17 YR
• Patient Weight: 64