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

Catalog Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Pain (1994); Perforation of Vessels (2135); Cramp(s) (2193); Anxiety (2328)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: tilt of filter and perforation of the vena cava.The patient suffered life-threatening injuries and damages, requiring 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 following additional information received per the medical records indicate that the patient need for inferior vena cava (ivc) filter because of contraindication to anticoagulation.During filter implantation a right internal jugular vein puncture was performed using a sonographic guidance.A 6f sheath was placed and positioned in the caudal aspect of the inferior vena cava (ivc).An inferior venacavogram was performed.Subsequently, the filter was placed in the caudal aspect of the ivc, well below the level of the renal veins.There were no immediate peri-procedural complications.Then, the initial venocavagram showed a patent ivc.Completion venogram showed good positioning of the inferior vena cava filter in the caudal aspect of the ivc wall below the level of the renal veins.No complications are identified.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events on-or-about fourteen years and seven months post filter implantation, the patient¿s device is reportedly unable to be retrieved however, there have been no known attempts made to remove the filter.It is also alleged that the patient¿s legs do not work well, it¿s hard to even walk two (2) blocks.The patient stated to experience occasional pain at filter site, mental anguish/anxiety for fear of further injury by the filter due to irretrievability of filter and legs and feet cramp making rest and sleep difficult.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 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 presence of a thrombosis does not represent a device malfunction.The placement of an ivc filter is not a treatment for thrombosis.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without medical records available for review, the clinical reasons for the pain, cramping and difficulty in walking experienced by the patient is inconclusive.Possible causes may by co-morbidities, pharmacological or patient factors.Without procedural films for review, the reported filter tilt 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 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.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 the legal brief, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to tilt of filter and perforation of the vena cava.The patient suffered life-threatening injuries and damages, requiring 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 following additional information received per the medical records indicate that the patient need for inferior vena cava (ivc) filter because of contraindication to anticoagulation.During filter implantation a right internal jugular vein puncture was performed using a sonographic guidance.A 6f sheath was placed and positioned in the caudal aspect of the inferior vena cava (ivc).An inferior venacavogram was performed.Subsequently, the filter was placed in the caudal aspect of the ivc, well below the level of the renal veins.There were no immediate periprocedural complications.Then, the initial venocavagram showed a patent ivc.Completion venogram showed good positioning of the inferior vena cava filter in the caudal aspect of the ivc wall below the level of the renal veins.No complications are identified.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events on-or-about fourteen years and seven months post filter implantation, the patient¿s device is reportedly unable to be retrieved however, there have been no known attempts made to remove the filter.Also patient¿s alleged legs do not work well, it¿s hard to even walk two (2) blocks.Occasionally pain at filter site.Mental anguish/anxiety for fear of further injury by the filter due to irretrievability of filter.Legs and feet cramp making rest and sleep difficult.

• Brand Name: 466P306X
• 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: 7652533
• MDR Text Key: 112841035
• Report Number: 1016427-2018-01609
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: No
• 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; Disability
• Patient Age: 63 YR