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

Model Number 466FXXXX

Device Problems Bent (1059); Fracture (1260); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

The products were not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.

Event Description

As reported by the legal team, the patient underwent placement of the trapease vena cava filter.Thirteen years later, 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, one strut was bent, one strut had fractured and at least five 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

As reported, the patient underwent placement of the trapease vena cava filter.Thirteen years later, 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, one strut was bent, one strut had fractured and at least five struts were significantly perforating the inferior vena cava (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.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 images or procedural films for review, the reported filter fracture and tilt could not be confirmed and the exact cause could not be determined.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.The timing and mechanism of the reported filter tilt could not be determined.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/or 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 was received from a patient profile form (ppf) that there was perforation of the filter strut(s) into organs, filter embedded in wall of the ivc and the device is unable to be retrieved.There were no removal attempts made.The patient stated she was now aware of the large number of device failures, is concerned that the device failure will get worse or cause damage to her body.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted, one strut was bent, one strut had fractured and at least five struts were significantly perforating the ivc.A ct scan was done approximately 13 years post implantation that revealed the tilt, strut bend and fracture and perforation.Per the patient profile form (ppf), there was perforation of the filter strut(s) into organs, filter was embedded in wall of the ivc and the device is unable to be retrieved.There were no removal attempts made.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.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.Filter strut deformation is a known potential product malfunction associated with the use of the ivc filters, the ivc is a dynamic vessel subjected to continuous physical forces and these forces may contribute to damage to the filter.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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does 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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 7163893
• MDR Text Key: 96353880
• Report Number: 1016427-2018-00960
• 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,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2007
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0904130
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/07/2017
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/10/2018; 03/12/2018; 07/13/2018
• Supplement Dates FDA Received: 02/06/2018; 07/11/2018; 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1