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

Catalog Number UNKNOWN

Device Problem Occlusion Within Device (1423)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #: unknown but referred to as a cook celect filter.Expiration date: unknown as lot # is unknown.Since catalog # is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Unknown as lot # is unknown.Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014." "on or about (b)(6) 2015, [pt] presented for removal of ivc filter.At that time, removal of the retrieval ivc filter was not accomplished secondary to complete total occlusion of the inferior vena cava below the filter." patient outcome: it is alleged that "[pt] suffered permanent and continuous injuries, pain and suffering, disability and impairment.[pt] has suffered emotional trauma, harm and injuries that will continue into the future.[pt] has lost his ability to live a normal life, and will continue to be so diminished into the future.Furthermore, [pt] has lost earnings and will continue to lose earnings into the future and have medical bills, both past and future, related to care because of the cook ivc filters¿ defects.".

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a cook celect filter.Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Summary of investigational findings: investigation is solely based on description of event.No product was returned and no imaging was provided.According to the description of event, the filter could not be removed, due to "total occlusion of the inferior vena cava below the filter." given the limited information provided, it would be inappropriate to speculate on what may or may not have led to the reported occlusion of the ivc.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 medical will continue to monitor for similar events.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014." "on or about (b)(6) 2015, [pt] presented for removal of ivc filter.At that time, removal of the retrieval ivc filter was not accomplished secondary to complete total occlusion of the inferior vena cava below the filter." patient outcome: it is alleged that "[pt] suffered permanent and continuous injuries, pain and suffering, disability and impairment.[pt] has suffered emotional trauma, harm and injuries that will continue into the future.[pt] has lost his ability to live a normal life, and will continue to be so diminished into the future.Furthermore, [pt] has lost earnings and will continue to lose earnings into the future and have medical bills, both past and future, related to care because of the cook ivc filters¿ defects.".

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6180026
• MDR Text Key: 62528075
• Report Number: 3002808486-2016-01481
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• 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): Life Threatening