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

Model Number 466P306X

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation (2001); No Consequences Or Impact To Patient (2199)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture of the filter.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 inferior vena cava (ivc) 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.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

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture of the ivc filter.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.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of morbid obesity and he was at a high risk for thromboembolic phenomenon secondary to his hypercoagulable state.The filter was deployed near the l-3 level.The patient tolerated the procedure well.According to the patient profile form (ppf) the patient submitted himself to a ct scan for evaluation of his filter eleven years after his index procedure.A scan indicated that multiple prongs had fractured.It was reported that the filter struts migrated, were embedded in the wall of the inferior vena cava and were unable to be retrieved.There was no documentation of an attempt to remove the filter.The patient profile form (ppf) states that the patient suffered pain, emotional distress, mental anguish, anxiety and stress.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Event: as reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of morbid obesity and he was at a high risk for thromboembolic phenomenon secondary to his hypercoagulable state.The filter was deployed near the l-3 level.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture of the ivc filter.According to the patient profile form (ppf), a ct scan indicated that multiple prongs had fractured.It was reported that the filter struts migrated, were embedded in the wall of the inferior vena cava and were unable to be retrieved.There was no documentation of an attempt to remove the filter.The patient profile form (ppf) states that the patient suffered pain, emotional distress, mental anguish, anxiety and stress.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.The dhr could not be completed.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.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 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 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.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.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.

Manufacturer Narrative

Additional information received per a legal short form states that the patient experienced tilting of the filter and perforation.As reported, the patient had placement of the trapease inferior vena cava (ivc) filter.Per the medical records, history includes morbid obesity with high risk for thromboembolic phenomenon secondary a hypercoagulable state.The filter was deployed near the l-3 level.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture of the ivc filter.Per the patient profile form (ppf), a ct scan, eleven years after his index procedure, revealed multiple prongs had fractured.It was reported that the filter struts migrated, were embedded in the wall of the inferior vena cava and were unable to be retrieved.There was no documentation of an attempt to remove the filter.The patient also reports pain, emotional distress, mental anguish, anxiety and stress.Additional information received states that the patient experienced tilting of the filter and perforation.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 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 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 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.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: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• MDR Report Key: 7207978
• MDR Text Key: 97851789
• Report Number: 1016427-2018-01057
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0804550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 07/06/2018; 05/30/2019
• Supplement Dates FDA Received: 04/08/2018; 07/13/2018; 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN DILATOR; UNKNOWN GUIDE WIRE; UNKNOWN NEEDLE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR