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

Catalog Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Pain (1994); Perforation (2001); Numbness (2415)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned, tilted within and perforated the inferior vena cava (ivc) wall and caused injury and damages to the patient, including, but not limited to, blood dots, clotting and occlusion of the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which require or required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer 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.The inferior 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.Blood clots and occlusion within the ivc does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films for review, the reported filter tilt and perforation of the ivc could not be confirmed.The timing and mechanism of the tilt has not been reported at this time.The brief also reported perforation of the ivc; 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.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 defendants' trapease vena cava filter.The filter subsequently malfunctioned, tilted within and perforated the inferior vena cava (ivc) wall and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and, occlusion of the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which require or required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the medical records indicate that patient underwent the placement of the ivc filter due to history of deep venous thrombosis (dvt) and pulmonary embolus (pe) that was poorly controlled with coumadin.The patient also had a history of degenerative lumbar disk disease and spinal fusion.During placement of the filter via right common femoral vein, the filter was deployed at the infrarenal position with minimal angulation and no apparent complications.Approximately on or about nine years and six months post ivc filter implantation, the filter was removed percutaneously for concern of the filter being the source of abdominal pain in the patient.During removal of the filter via the right common femoral vein and right internal jugular vein, contrast injection through the micropuncture sheath demonstrated the ivc filter extend beyond the walls of the vena cava.No significant thrombus was noted within the filter itself and the filter was constraint completely within the laser sheath and was successfully removed.The removed filter was examined and found to be intact without evidence of fractured parts.Post removal contrast injection demonstrated slight narrowing and irregularity along the ivc wall but no evidence of extravasation.The patient tolerated the removal well with no immediate complications.According to the information received in the patient profile form (ppf), sometime post implantation of the ivc filter, the patient reports to suffer from anxiety, abdominal pain, chest pain, and numbness in left leg.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of an trapease inferior vena cava (ivc) filter.Per the medical records, the patient underwent the placement of the ivc filter due to history of deep venous thrombosis (dvt) and pulmonary embolus (pe) that was poorly controlled with coumadin.The patient also had a history of degenerative lumbar disk disease and spinal fusion.During placement of the filter via right common femoral vein, the filter was deployed at the infrarenal position with minimal angulation and no apparent complications.The filter subsequently malfunctioned, tilted within and perforated the inferior vena cava (ivc) wall and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and, occlusion of the ivc.Approximately nine years and six months post ivc filter implantation, the filter was removed percutaneously for concern of the filter being the source of abdominal pain for the patient.During removal of the filter, via the right common femoral vein and right internal jugular vein, contrast injection demonstrated the ivc filter extend beyond the walls of the vena cava.No significant thrombus was noted within the filter itself and the filter was constraint completely within the laser sheath and was successfully removed.The removed filter was examined and found to be intact without evidence of fractured parts.Post removal contrast injection demonstrated slight narrowing and irregularity along the ivc wall but no evidence of extravasation.The patient tolerated the removal well with no immediate complications.Per the patient profile form (ppf), sometime post implantation of the ivc filter, the patient reports to suffer from anxiety, abdominal pain, chest pain, and numbness in left leg.The filter remains implanted; thus, unavailable for analysis.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 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.It was also 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.Blood clots, clotting and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, pain and numbness 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7268282
• MDR Text Key: 99984680
• Report Number: 1016427-2018-01166
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2018

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 04/14/2018
• Supplement Dates FDA Received: 04/06/2018; 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 J-WIRE; UNKNOWN 6-FRENCH SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 55 YR