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 Occlusion Within Device (1423); Insufficient Information (3190)

Patient Problems Death (1802); Pulmonary Emphysema (1832); Thrombosis (2100); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Multiple Organ Failure (3261)

Event Date 06/23/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Description of event according to study: at the index procedure on (b)(6) 2016 a celect® filter (lot # e3408055) was placed.The inferior vena cava (ivc) diameter at the intended filter location was 21 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 (lot # e3408055) 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, tilt, or migration.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.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 19.6 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 10.5 degrees.On (b)(6) 2016 (two days post-procedure), the patient was diagnosed with a dvt and a caval thrombosis, which were treated with thrombectomy.The physician indicated the pre-existing condition of history of pulmonary embolism and anticoagulation prior to admission may have caused or contributed to these events.On the same day, the patient was diagnosed with cardiogenic shock which lead to multi-system organ failure resulting in death on (b)(6) 2016 (three days post-procedure).Patient outcome: on (b)(6) 2016 (three days post-procedure), the patient died.The cause of death as determined by an in-hospital evaluation at demise was cardiogenic shock related to a preexisting condition.The device did not malfunction or deteriorate in characteristics or performance.

Manufacturer Narrative

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

Event Description

Description of event according to study: at the index procedure on (b)(6) 2016 a celectfilter (lot # e3408055) was placed.The inferior vena cava (ivc) diameter at the intended filter location was 21 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 (lot # e3408055) 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, tilt, or migration.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.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 19.6 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 10.5 degrees.On (b)(6) 2016 (two days post-procedure), the patient was diagnosed with a dvt and a caval thrombosis, which were treated with thrombectomy.The physician indicated the pre-existing condition of history of pulmonary embolism and anticoagulation prior to admission may have caused or contributed to these events.On the same day, the patient was diagnosed with cardiogenic shock which lead to multi-system organ failure resulting in death on 06/24/2016 (three days post-procedure).Additional information received on 29jul2016: ultrasound analysis: thrombus is present in the left lower extremity.Thrombus is occluding the left lower extremity.It is unknown whether the thrombus is new or pre-existing.Venogram analysis: presence of new thrombus in the ivc that is cranial to the filter, caudal to the filter, and within the filter.The thrombus is occluding the ivc.Presence of new thrombus in the pelvic veins bilaterally.The thrombus is occluding the pelvic veins.Thrombus is present in the left lower extremity.Thrombus is occluding the left lower extremity.It is unknown whether the thrombus is new or pre-existing.Patient outcome: on (b)(6) 2016 (three days post-procedure), the patient died.The cause of death as determined by an in-hospital evaluation at demise was cardiogenic shock related to a preexisting condition.The device did not malfunction or deteriorate in characteristics or performance.

Manufacturer Narrative

(b)(4).Summary of investigational findings: it is unclear whether the cardiogenic shock could be related to the ivc/iliac thrombosis or potential escaped emboli extending to the pulmonary arteries leading to subsequent demise, as the patient had a history of pe, hypertension, pulmonary hypertension and cor pulmonale.Consequently, it is unknown if the cardiogenic shock and ultimate demise was related to the filter.Pe is a known risk in relation to filter implant reported in the published scientific literature.No evidence to suggest that this device was not manufactured according to specifications.A reference is made to the instructions for use (celect): potential adverse events: damage to the vena cava, pulmonary embolism, filter embolization, vena cava perforation, vena cava occlusion or thrombosis, hemorrhage, extravasation of contrast material at time of vena cavagram, hematoma at vascular access site, infection at vascular access site, thrombosis or stenosis at implant site, death.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to study: at the index procedure on (b)(6) 2016 a celect filter (lot # e3408055) was placed.The inferior vena cava (ivc) diameter at the intended filter location was 21 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 (lot # e3408055) 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, tilt, or migration.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.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 19.6 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 10.5 degrees.On (b)(6) 2016 (two days post-procedure), the patient was diagnosed with a dvt and a caval thrombosis, which were treated with thrombectomy.The physician indicated the pre-existing condition of history of pulmonary embolism and anticoagulation prior to admission may have caused or contributed to these events.On the same day, the patient was diagnosed with cardiogenic shock which lead to multi-system organ failure resulting in death on (b)(6) 2016 (three days post-procedure).Additional information received on 29jul2016: ultrasound analysis: thrombus is present in the left lower extremity.Thrombus is occluding the left lower extremity.It is unknown whether the thrombus is new or pre-existing.Venogram analysis: presence of new thrombus in the ivc that is cranial to the filter, caudal to the filter, and within the filter.The thrombus is occluding the ivc.Presence of new thrombus in the pelvic veins bilaterally.The thrombus is occluding the pelvic veins.Thrombus is present in the left lower extremity.Thrombus is occluding the left lower extremity.It is unknown whether the thrombus is new or pre-existing.Patient outcome: on (b)(6) 2016 (three days post-procedure), the patient died.The cause of death as determined by an in-hospital evaluation at demise was cardiogenic shock related to a preexisting condition.The device did not malfunction or deteriorate in characteristics or performance.

• 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: 5788636
• MDR Text Key: 49362137
• Report Number: 3002808486-2016-00702
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)190120(10)E3408055
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• 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: 07/08/2016
• Date Device Manufactured: 01/20/2016
• 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): Death
• Patient Age: 77 YR
• Patient Weight: 141