MAUDE Adverse Event Report: WILLIAM COOK EUROPE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-JUG-CELECT

Device Problems Material Erosion (1214); Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Occlusion (1984); Pain (1994); Perforation of Vessels (2135); Great Vessel Perforation (2152); Injury (2348)

Event Date 12/01/2012

Event Type  malfunction  

Event Description

Description according to complainant: it is alleged that "pt had a history of deep vein thrombosis (dvt) that caused him to be admitted to (b)(6) on (b)(6) 2011.There it was determined that an ivc filter would be implanted.On that same day, the celect filter was inserted into pt.There were no complications at that time.On or about (b)(6) 2012, pt experienced a perforation of the vena cava." patient outcome: it is alleged that "pt suffered significant and severe injuries to his body".

Manufacturer Narrative

Udi#: (b)(4).Unknown as information was not provided by reporter.Based on very limited information it is not possible to determine if this is an adverse event or product problem.It is alleged that "pt suffered significant and severe injuries to his body".No device, imaging studies or hospital or medical records have been available.Consequently, based on very limited information it is difficult to comment on the alleged perforation of vena cava approx.One year after filter placement.However, investigation found 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.The exact root cause for the alleged perforation of vena cava cannot be determined based on the limited information provided.William cook (b)(4) will continue to monitor for similar events.

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on (b)(6) 2015 as follows: plaintiff allegedly received an implant on (b)(6) 2011 via the internal jugular vein due to pe.Plaintiff is alleging vena cava perforation, device is unable to be retrieved, pain, shortness of breath.

Manufacturer Narrative

Exemption number e2016032.William cook (b)(4) aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer (b)(4).Additional information: investigation is reopened due to additional information provided.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 "vena ivc perforation and occlusion, unable to retrieve, pain, sob." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.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.Unknown if the reported pain and shortness of breath (sob) are directly related to the filter.No relevant notes found on work order or device lot.No other complaints on lot.Product is manufactured and inspected according to specifications.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.

Event Description

No additional information provided at this time.

Manufacturer Narrative

(b)(4).Exemption number e2016032.William cook (b)(4) aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).(b)(4).

Event Description

Per physicians notes, (b)(6) 2013, "the patient has obviously an occluded inferior vena cava with thrombus extending to both lower extremities all the way past the knee.[patient] has developed some recanalization of some collaterals which account for the improvement of the edema.As far as the vena cava filter is appears to have eroded through the walls of the vena cava and has lead to the occlusion of the vena cava.".

Manufacturer Narrative

Exemption number e2016032.William cook (b)(5) aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer reference # (b)(4).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 'vena cava perforation, device is unable to be retrieved, pain, shortness of breath '.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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.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: NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov 4632, IN 47404 ; 8004574500
• MDR Report Key: 4392320
• MDR Text Key: 16452372
• Report Number: 3002808486-2014-00079
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2014
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Device Lot Number: E2812837
• Other Device ID Number: UDI#: (01)10827002529097(17)14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/28/2014
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR