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

Model Number 466P306AU

Device Problems Fracture (1260); Failure to Align (2522); Migration (4003)

Patient Problems Coagulation Disorder (1779); Perforation (2001); Obstruction/Occlusion (2422)

Event Date 06/23/2021

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by legal brief, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: perforation and tilt.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: perforation and tilt.The following additional information was received per the patient¿s medical records: the patient had a catheter placed for thrombolysis and was brought for a follow-up venogram.The preoperative diagnosis was extensive deep venous thrombosis.The venogram performed showed increased flow present, but still a large amount of clot in the iliac.The superficial femoral vein was partially opened, and the femoral vein was partially opened.An angiogram performed showed there was a large amount of clot in the distal vena cava at the bifurcation with clot extending from the right and left iliac veins.A long 6f sheath was then placed up past the clot up into the vena cava.The filter was deployed below the renal veins.An angioplasty of the iliac vein was then performed.The superficial femoral vein also had lots of clot present.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately ten years and nine months post implantation.The patient reports perforation of the filter strut(s) outside the ivc and tilt.The patient also reports suffering from anxiety.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 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.Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.The timing and mechanism of the tilt has not been reported at this time.The brief also reported an ivc perforation; however, 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.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.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 legal brief, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: perforation and tilt.The following additional information was received per the patient¿s medical records: the patient had a catheter placed for thrombolysis and was brought for a follow-up venogram.The preoperative diagnosis was extensive deep venous thrombosis.The venogram performed showed increased flow present, but still a large amount of clot in the iliac.The superficial femoral vein was partially opened, and the femoral vein was partially opened.An angiogram performed showed there was a large amount of clot in the distal vena cava at the bifurcation with clot extending from the right and left iliac veins.A long 6f sheath was then placed up past the clot up into the vena cava.The filter was deployed below the renal veins.An angioplasty of the iliac vein was then performed.The superficial femoral vein also had lots of clot present.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately ten years and nine months post implantation.The patient reports perforation of the filter strut(s) outside the ivc and tilt.The patient also reports suffering from anxiety.

Manufacturer Narrative

Additional information was provided and is available in: (evaluation codes) 2135 - vessels, perforation of additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and tilt.The patient reported becoming aware of the events approximately ten years and nine months post implant.The patient also reported anxiety related to the filter.According to the medical records the patient had a catheter placed for thrombolysis for extensive deep vein thrombosis.A follow up venogram was performed and showed increased flow present, but still a large amount of clot in the left iliac vein.The superficial femoral vein was partially opened, and the femoral vein was partially opened.An angiogram performed showed there was a large amount of clot in the distal vena cava at the bifurcation with clot extending from the right and left iliac veins.A long 6f sheath was then placed up past the clot up into the vena cava.The filter was deployed below the renal veins.An angioplasty of the iliac vein was then performed.The superficial femoral vein also had lots of clot present.The patient subsequently reported becoming aware of migration of the filter, fractured filter struts retained within the ivc, perforation abutting an adjacent organ, blood clots, clotting and occlusion of the ivc, approximately thirteen years and six months post implant.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 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.Blood clots, clotting and occlusion of the device or the vasculature do not represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without images or procedural films for review, the reported filter tilt, fracture, migration and perforation events could not be confirmed, nor an exact cause determined.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Additionally, the timing and mechanism of the events are unknown.The instructions for use (ifu) states that 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.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 ivc 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.It is unknown if the tilt contributed to the reported perforation.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.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.

Event Description

According to the information received in the redacted-amended patient profile form (ppf), the patient additionally reports migration of the filter, fractured filter struts retained within the ivc, perforation abutting an adjacent organ, blood clots, clotting and occlusion of the ivc, becoming aware of these events about thirteen years and six months post implant.

• 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
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8263023
• MDR Text Key: 133713160
• Report Number: 1016427-2019-02443
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/09/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0507277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/28/2019; 02/27/2019; 11/16/2021
• Supplement Dates FDA Received: 02/27/2019; 03/01/2019; 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2007
• 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): Life Threatening
• Patient Age: 34 YR
• Patient Sex: Female