MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE W/CSI INTRO KIT 55CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306A

Device Problems Kinked (1339); Retraction Problem (1536); Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of trapease vena cava filter on or about (b)(6) 2002.In or about (b)(6) 2017, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) and the filter was significantly tilted, buckled and bent and approximately three strut were significantly perforating the ivc.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, 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 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 of the ivc could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without films for review, the reported ¿buckled and bent¿ and ivc perforation could not be confirmed.The timing and mechanism of the event is unknown at this time.It is possible that specific physical and mechanical characteristics of the filter may be influenced in different ways by the specific clinical scenario, ivc anatomy and compliance, and the underlying hemodynamics to which the device is exposed.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 trapease vena cava filter on or about (b)(6) 2002.In or about (b)(6) 2017, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) and the filter was significantly tilted, buckled and bent and approximately three strut were significantly perforating the ivc.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, pain and suffering, and other damages.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Describe event or problem: additional information received per the medical records.The device was implanted due to deep vein thrombosis, saddle embolism, pulmonary embolism, hematemesis, and syncope.The patient was reported to have tolerated the index procedure well.The patient is reported to continue to experience anxiety related to the device.As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per the patient profile form (ppf), the device was implanted due to deep vein thrombosis, saddle embolism, pulmonary embolism, hematemesis, and syncope.The patient was reported to have tolerated the index procedure well.Approximately 14 years after the filter was implanted, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) and the filter was significantly tilted, buckled and bent and approximately three strut were significantly perforating the ivc.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, pain and suffering, and other damages.The patient is reported to continue to experience anxiety related to the device.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.Without procedural films for review, the filter tilt and deformation reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt with deformation is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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 the deformation of the filter device.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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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 W/CSI INTRO KIT 55CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6789568
• MDR Text Key: 82528177
• Report Number: 1016427-2017-00525
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2005
• Device Catalogue Number: 466P306A
• Device Lot Number: R0802192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR