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

Catalog Number 466P306X

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

Patient Problems Perforation (2001); Stenosis (2263)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

Please note the exact event date is unknown and that the event date is the complaint awareness date.As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt and fracture of the ivc filter, perforation of the caval wall, and stenosis.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.No additional information is available.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) 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.A stenosis is an abnormal narrowing in a blood vessel.Without medical records available it is not possible to determine the location/cause of the stenosis.Without procedural films for review, the reported filter tilt and fracture could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.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.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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt and fracture of the ivc filter, perforation of the caval wall, and stenosis.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.No additional information is available.

Manufacturer Narrative

Product name trapease pvcf fem/jug 55cm csi.Product catalog number 466p306au lot number 15574825.(b)(6).According to the information received in the patient profile from (ppf) the following additional information received per the medical records indicate that the device was implanted due to patient history of deep vein thrombosis (dvt).The ivc filter was placed at the l3 without any complications.According to the information received in the patient profile from (ppf), the patient became aware of the reported events approximately on or about five years and twenty-three days post implantation via a ct scan.The stent caused distortion and displacement of the medial and anteromedial filter struts causing fracture bending.The patient now suffers from pain, anxiety, and swelling due to these complications.The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: it was reported that a patient underwent placement of a trapease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, fracture bending of the ivc filter, perforation of filter strut outside the ivc, and stenosis.The patient submitted for a computerized tomography (ct) scan approximately five years and one-month post implant, it was noted on the scan that the filter tilted and perforated outside the ivc.The stent caused distortion and displacement of the medial and anteromedial filter struts causing fracture bending and stenosis.The patient is also reported to have experienced anxiety, pain and swelling associated with the findings.The anatomical location of the pain and swelling has not been provided.The indication for the device implant was a history of deep vein thrombosis (dvt).The filter was placed at the level of l3 without complications.There is currently no additional information available.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.Filter fracture and vessel perforation are known adverse events associated with implanting vena cava filters and are 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.Without procedural films for review, the reported filter fracture, perforation and kink/distortion of the filter could not be confirmed, and the exact cause could not be determined.The timing and mechanism of the fracture and perforation are unknown at this time.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.Anatomical 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.Without the procedural films or post implant imaging available for review the reported events of fracture, perforation, kink and stenosis could not be confirmed or further clarified.Anxiety, pain and swelling do 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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 7214554
• MDR Text Key: 98045552
• Report Number: 1016427-2018-01093
• 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
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 466P306X
• Device Lot Number: 15574825
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/26/2017
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR