MAUDE Adverse Event Report: CORDIS CORPORATION 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problems Fracture (1260); Difficult to Remove (1528); Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

As reported in a legal brief, a patient underwent placement of a trapease vena cava filter on or about (b)(6) 2003.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, fracture with migration of fractured struts to the heart and lung, blocking blood flow; inability to remove fractured struts due to high risk, requiring close monitoring and use of multiple blood thinners; and pulmonary embolism, with blood clots to the heart.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  the product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.  the trapease filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.  the purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots and thrombosis does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Without procedural films for review, the reported filter fracture/separated and migration could not be confirmed and the exact cause could not be determined.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.However, given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

Plaintiff underwent placement of defendants' trapease vena cava filter on or about (b)(6) 2003.The filter subsequently malfunctioned and caused injury and damages to plaintiff , including, but not limited to, fracture with migration of fractured struts to the heart and lung, blocking blood flow; inability to remove fractured struts due to high risk, requiring close monitoring and use of multiple blood thinners; and pulmonary embolism, with blood clots to the heart.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff  has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.Plaintiff at all times relevant to this action was and is a citizen and resident of the state of texas.Plaintiffs were and are, at all times relevant to this action, legally married as husband and wife.Plaintiff brings this action for, inter alia, the loss of consortium, comfort, and society she suffered due to the personal injuries suffered by her husband.

Manufacturer Narrative

The following additional information received per the patient profile form indicates that twelve years and sixteen days post implantation, the patient had occlusion of the inferior vena cava (ivc).Twelve years and twenty eight days post implantation, the patient¿s filter was attempted to be removed but the attempt was unsuccessful.The patient also reports from fear, anxiety, mental anxiety and depression.According to the medical records, the fractured struts were identified to be within the right atrium, the right ventricle, and the middle lobe of the pulmonary artery.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The indication for the implant has not been provided.It was reported that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, fracture with migration of fractured struts to the heart and lung, blocking blood flow; inability to remove fractured struts due to high risk, requiring close monitoring and use of multiple blood thinners; and pulmonary embolism, with blood clots to the heart.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.Additional information indicated that approximately twelve years post implant the patient experienced occlusion of the inferior vena cava (ivc).Twelve years and twenty-eight days post implantation, an unsuccessful attempt was made to remove the filter.According to the information provided the retrieval attempt was due to imaging showing fragmented and migrated ivc filter fragments within the right atrium, right ventricle and right middle lobe pulmonary artery.The procedural documentation indicates that the filter was no longer within the inferior vena cava, but was situated at the cavo-atrial junction and right atrium.Due to the angle of the filter a snare device was advanced to the filter and successfully wrapped around portions of the filter several times, however upon applying traction the filter was too adherent to the wall to safely remove.There were no immediate complications and the procedure was terminated.It was believed that the filter had migrated at least nine months, if not years prior to the retrieval attempt.It is also reported that the patient experiences fear, anxiety, mental anxiety and depression.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Without images or procedural films for review, the reported filter strut migration, strut fracture and retrieval difficulty, pulmonary embolism, cardiac thrombosis, clotting, vena caval occlusion could not be confirmed and the exact cause could not be determined.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to determine a relationship between the device and the reported events, there is currently nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6126313
• MDR Text Key: 60846429
• Report Number: 1016427-2016-00126
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/31/2016
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention; Disability