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

Catalog Number IGTCFS-65-1-JUG-CELECT-PT

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problems Pain (1994); Perforation of Vessels (2135); Palpitations (2467)

Event Date 08/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #igtcfs-65-1-jug-celect-pt.Investigation is still in progress.

Event Description

Description of event according to study: on (b)(6) 2016, during the index procedure a celect® filter igtcfs-65-1-jug-celect-pt lot # e3387649 was placed.The inferior vena cava (ivc) diameter at the intended filter location was 22 mm.There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.Using the right internal jugular vein as the access site, a celect® filter was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe).The filter neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, or migration.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.The filter angle of tilt was 6 -< 11 degrees.Analysis of the placement procedure venacavagram revealed no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.The filter was placed in the ivc infrarenal site, and the ivc diameter at the filter location was 19.1 mm.There was no evidence of filter migration, extravasation of contrast, or deformation.Filter legs did appear outside the column of contrast after filter placement.The angle of filter tilt in the ap view was 11 degrees.Post-procedure x-ray dated (b)(6) 2016 (day of procedure) site: filter tilt was 6 - < 11 degrees.No evidence of filter fracture, embolization, or migration.Analysis show no evidence of filter fracture, deformation, embolization, or migration.The angle of filter tilt in the ap view was 16.4 degrees and 5.2 degrees in the lat view.On (b)(6) 2016 (49 days post-procedure), the patient underwent filter retrieval.The filter was no longer clinically needed.The physician indicated there were major difficulties attempting to remove the filter which was eventually removed endovascularly.Information regarding the pre-retrieval procedure was received by email from the site.The site indicated that the pre-retrieval x-ray and venacavagram demonstrated significant tilt (¿approximately 20 degrees¿).Per the site, it became apparent during the procedure that the hook of the device was ¿severely embedded in the caval wall.¿ a gunther tulip® retrieval set and loop snare technique were attempted without success.The site indicated ¿during loop snare technique attempt on of the filter struts straightened out almost completely-but remained whole to the tip of the cone.¿ the filter was then secured in forceps and retrieved through a 20 french sheath.Upon visual inspection of the retrieved device it was noted that a strut was missing.A dyna-ct scan revealed the strut was located in the patient¿s right atrium.The strut was retrieved endovascularly from the right atrium.No other details regarding the procedure for retrieving the strut have been received.Pre-retrieval imaging has not yet been received.(b)(4).Addendum: on (b)(6) 2016, (one day post retrieval procedure), the patient was diagnosed with a cardiac arrhythmia which the physician has indicated was probably related to the study device and the study procedure and indicated that the device malfunctioned or deteriorated in characteristics or performance.Patient outcome: treatment of the ventricular tachycardia arrhythmia was holter monitoring to further evaluate heart palpitations.The patient complained of intermittent palpitations.

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-jug-celect-pt.(b)(4).Investigation is still in progress.

Event Description

Description of event according to study: on (b)(6) 2016 during the index procedure a celect(tm) filter igtcfs-65-1-jug-celect-pt lot # e3387649 was placed.The inferior vena cava (ivc) diameter at the intended filter location was 22 mm.There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.Using the right internal jugular vein as the access site, a celect(tm) filter was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe).The filter neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, or migration.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.The filter angle of tilt was 6 -< 11 degrees.Analysis of the placement procedure venacavagram revealed no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.The filter was placed in the ivc infrarenal site, and the ivc diameter at the filter location was 19.1 mm.There was no evidence of filter migration, extravasation of contrast, or deformation.Filter legs did appear outside the column of contrast after filter placement.The angle of filter tilt in the ap view was 11 degrees.Post-procedure x-ray dated (b)(6) 2016 (day of procedure).Site: filter tilt was 6 - < 11 degrees.No evidence of filter fracture, embolization, or migration.Analysis show no evidence of filter fracture, deformation, embolization, or migration.The angle of filter tilt in the ap view was 16.4 degrees and 5.2 degrees in the lat view.On (b)(6) 2016 (49 days post-procedure), the patient underwent filter retrieval.The filter was no longer clinically needed.The physician indicated there were major difficulties attempting to remove the filter which was eventually removed endovascularly.Information regarding the pre-retrieval procedure was received by email from the site.The site indicated that the pre-retrieval x-ray and venacavagram demonstrated significant tilt ("approximately 20 degrees").Per the site, it became apparent during the procedure that the hook of the device was "severely embedded in the caval wall." a gunther tulip(tm) retrieval set and loop snare technique were attempted without success.The site indicated "during loop snare technique attempt on of the filter struts straightened out almost completely-but remained whole to the tip of the cone." the filter was then secured in forceps and retrieved through a 20 french sheath.Upon visual inspection of the retrieved device it was noted that a strut was missing.A dyna-ct scan revealed the strut was located in the patient's right atrium.The strut was retrieved endovascularly from the right atrium.No other details regarding the procedure for retrieving the strut have been received.Pre-retrieval imaging has not yet been received.On (b)(6) 2016: addendum: on (b)(6) 2016, (one day post retrieval procedure), the patient was diagnosed with a cardiac arrhythmia which the physician has indicated was probably related to the study device and the study procedure and indicated that the device malfunctioned or deteriorated in characteristics or performance.Additional information received (b)(6) 2016: on (b)(6) 2016, the patient complained of right neck/access site pain.Treatment included lidoderm patch prescription and referral for physical therapy.The pi indicated the event was "possibly" due to the retrieval procedure.Patient outcome: treatment of the ventricular tachycardia arrhythmia was holter monitoring to further evaluate heart palpitations.The patient complained of intermittent palpitations.Additional information received (b)(6) 2016: the patient remains in the study.

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-jug-celect-pt.Summary of investigational findings: imaging review confirmed tilt, perforation and mild migration.Unfortunately, the images from the retrieval only demonstrate attempts at performing a guidewire loop snare technique and not the actual retrieval.Therefore, the fracture during retrieval attempts and the mayor difficulties while attempting to retrieve the filter cannot be confirmed by imaging.Given the placement of the hook in close proximity to the ivc wall, it is highly probable, that this is the cause of the reported filter retrieval difficulties experienced.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.From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk.Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques.The fracture and embolization of the strut was directly related to the attempted retrieval technique described.By engaging the filter strut, instead of the body of the filter using a guidewire loop snare technique, and straightening the strut, this likely introduced weakening or incomplete fracture at the junction of the strut and body of the filter.When the filter was retracted into the sheath, this caused the strut to completely break free of the filter body and embolized to the right atrium.Filter fracture of the wire is an uncommon, but known risk in relation to filter implant.However, in this case the filter fracture occurred during retrieval and not during the implant period.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature.Filter tilt may happen during placement or during implanting period.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.In this case patient was symptomatic reported as right neck/access site pain.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 of event according to study: on (b)(6) 2016 during the index procedure, a celect® filter igtcfs-65-1-jug-celect-pt lot # e3387649 was placed.The inferior vena cava (ivc) diameter at the intended filter location was 22 mm.There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.Using the right internal jugular vein as the access site, a celect® filter was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe).The filter neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, or migration.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.The filter angle of tilt was 6 -< 11 degrees.Analysis of the placement procedure venacavagram revealed no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.The filter was placed in the ivc infrarenal site, and the ivc diameter at the filter location was 19.1 mm.There was no evidence of filter migration, extravasation of contrast, or deformation.Filter legs did appear outside the column of contrast after filter placement.The angle of filter tilt in the ap view was 11 degrees.Post-procedure x-ray dated (b)(6) 2016 (day of procedure).Site: filter tilt was 6 - < 11 degrees.No evidence of filter fracture, embolization, or migration.Analysis show no evidence of filter fracture, deformation, embolization, or migration.The angle of filter tilt in the ap view was 16.4 degrees and 5.2 degrees in the lat view.On (b)(6) 2016 (49 days post-procedure), the patient underwent filter retrieval.The filter was no longer clinically needed.The physician indicated there were major difficulties attempting to remove the filter which was eventually removed endovascularly.Information regarding the pre-retrieval procedure was received by email from the site.The site indicated that the pre-retrieval x-ray and venacavagram demonstrated significant tilt (approximately 20 degrees).Per the site, it became apparent during the procedure that the hook of the device was severely embedded in the caval wall.A gunther tulip® retrieval set and loop snare technique were attempted without success.The site indicated during loop snare technique attempt on of the filter struts straightened out almost completely-but remained whole to the tip of the cone.The filter was then secured in forceps and retrieved through a 20 french sheath.Upon visual inspection of the retrieved device it was noted that a strut was missing.A dyna-ct scan revealed the strut was located in the patient's right atrium.The strut was retrieved endovascularly from the right atrium.No other details regarding the procedure for retrieving the strut have been received.Pre-retrieval imaging has not yet been received.Addendum: on 11aug2016, (one day post retrieval procedure), the patient was diagnosed with a cardiac arrhythmia which the physician has indicated was probably related to the study device and the study procedure and indicated that the device malfunctioned or deteriorated in characteristics or performance.Additional information received (b)(4) 2016: on (b)(6) 2016, the patient complained of right neck/access site pain.Treatment included lidoderm patch prescription and referral for physical therapy.The pi indicated the event was possibly due to the retrieval procedure.Patient outcome: treatment of the ventricular tachycardia arrhythmia was holter monitoring to further evaluate heart palpitations.The patient complained of intermittent palpitations.Additional information received (b)(4) 2016: the patient remains in the study.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
• 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: 5931877
• MDR Text Key: 54023266
• Report Number: 3002808486-2016-01031
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)181117(10)E3387649
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• Date Device Manufactured: 11/17/2015
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73