MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problems Failure to Align (2522); Migration (4003)

Patient Problem Perforation of Vessels (2135)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of trapease vena cava filter on or about (b)(6) 2005.In or about (b)(6) 2017, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least one strut was significantly perforation the inferior vena cava (ivc).As a direct and proximate result of these malfunction, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

As reported in a legal brief, a patient underwent placement of a trapease vena cava filter on or about (b)(6) 2005.In or about (b)(6) 2017, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least one strut was significantly perforation the inferior vena cava (ivc).As a direct and proximate result of these malfunction, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, 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.Without procedural films for review the reported filter tilt and vessel perforation could not be confirmed and the exact cause could not be determined.The timing and mechanism of the filter tilt is unknown at this time.Incorrect orientation of the filter is a known potential complication for all ivc filter implants and is listed in the ifu as such.A filter may become tilted during implantation or during retrieval of the device.The filter may also be influenced by the specific clinical scenario, the ivc anatomy and compliance, and the underlying hemodynamics to which the device is exposed.It is unknown at this time if the reported filter tilt contributed to perforation of the ivc.Vessel injury is a well-known potential complication for all ivc filter implants and is listed in the instructions for use (ifu) as such.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.

Manufacturer Narrative

It was reported that a patient underwent placement of trapease vena cava filter.Approximately twelve years after the implantation of the filter, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least one strut was significantly perforation the inferior vena cava (ivc).The following additional information received per the patient profile form (ppf) indicates the patient continues to experience anxiety related to the device.The indication for the device implant, the patient¿s medical history and the procedural notes have not been provided.There is currently no additional information available.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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and perforation of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.The trapease vena cava 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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, there is 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.Should additional information become available, the file will be updated accordingly.

Event Description

Additional information received per an amended patient profile form (ppf) states that in addition to the previously reported filter tilt and inferior vena cava (ivc) perforation; the patient also experienced migration of entire filter other than to heart and filter has perforated outside the ivc and is abutting an adjacent organ.The patient became aware of the additional reported events nineteen years and six months after the index procedure.The patient continues to experience anxiety related to the device.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b3, b4, b5, b6, d1, e4, g4, g7, h1, h2 and h6.It was reported that a patient underwent placement of trapease vena cava filter.Approximately twelve years post filter implant, the patient underwent an updated computed tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused tilt and at least one strut was significantly perforating the inferior vena cava (ivc).The patient also reported anxiety related to the filter.Additional information received from the patient indicated that the patient also experienced migration of the filter other than to the heart and the filter has perforated outside the ivc and is abutting an adjacent organ.The patient became aware of the additional reported events nineteen years and six months post implant.The indication for the device implant, the patient¿s medical history and the procedural notes have not been provided.There is currently no additional information available.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 vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 post implant images or procedural films for review, the reported filter tilt, migration, and perforation could not be confirmed, nor a cause determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include 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.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6790037
• MDR Text Key: 82561253
• Report Number: 1016427-2017-00529
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening