MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306AU

Device Problems Bent (1059); Fracture (1260); Kinked (1339); Failure to Align (2522); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Perforation (2001)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.As reported, the patient underwent placement of a trapease vena cava filter.Approximately ten years post implantation 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, the filter had migrated, one strut was bent, one strut had fractured, the tip of the filter was embedded in the anterior wall of the inferior vena cava (ivc) and at least four struts were significantly perforating the ivc.As a direct and proximate result of the malfunctions, 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 images or procedural films for review, the reported filter tilt, migration, fracture and perforation could not be confirmed and the exact cause could not be determined.The timing and mechanism of the reported filter tilt could not be determined.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.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.Inferior vena cava (ivc) filter migration is also 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.The brief also mentioned that the tip of the filter was embedded.Endothelialization, remodeling/restructuring of the internal lumen of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.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

As reported by the legal brief, the patient underwent placement of either defendant¿s trapease vena cava filter approximately ten years post implantation 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, the filter had migrated, one strut was bent, one strut had fractured, the tip of the filter was embedded in the anterior wall of the inferior vena cava (ivc) and at least four struts were significantly perforating the ivc.As a direct and proximate result of the malfunctions, 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

After further review of additional information received, the following sections have been updated accordingly: initial reporter occupation: other, litigation paralegal.Information received per the patient profile form (ppf) states that in addition to the previously reported events, the patient continues to experience stress and anxiety.The patient has also been to the emergency room several times due to pain.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Correction to (product code).

Manufacturer Narrative

The patient has a history of multiple recurrent pulmonary embolism while on anticoagulation therapy, shortness of breath and shortness of breath.The patient was also known to have other significant medical problems including cardiomyopathy, an ejection fraction of 15-20% and phlebitis.The device was implanted via right groin.The patient tolerated the procedure well.Information received per the patient profile form (ppf) states that in addition to the previously reported events, the patient continues to experience stress and anxiety.The patient has also been to the emergency room several times due to pain.As reported, the patient underwent placement of a trapease vena cava (ivc) filter.The indication for filter placement is not available.Approximately ten years post implantation the patient underwent a ct scan which revealed the filter significantly tilted, the filter had migrated, one strut was bent, one strut had fractured, the tip of the filter was embedded in the anterior wall of the inferior vena cava (ivc) and at least four struts were significantly perforating the ivc.Per the patient profile form (ppf), in addition to the previously reported events, the patient continues to experience stress and anxiety.The patient has also been to the emergency room several times due to pain.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.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 procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.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 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.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.Kink/bent or altered shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7150639
• MDR Text Key: 95908055
• Report Number: 1016427-2017-00922
• Device Sequence Number: 1
• Product Code: DTK
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2009
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0606087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 58 YR