MAUDE Adverse Event Report: CORDIS CASHEL 466P306AU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); Anxiety (2328)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter tilted & embedded in ivc wall; all struts penetrate ivc wall into pericaval/mesenteric fat; one strut penetrated wall of aorta, embedded; one strut in contact with lumbar vertebra.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.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter tilted & embedded in ivc wall; all struts penetrate ivc wall into pericaval/mesenteric fat; one strut penetrated wall of aorta, embedded; one strut in contact with lumbar vertebra.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.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.The legal briefing mentioned a perforation.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.It is unknown if the tilt contributed to the reported perforation.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Endothelialization, remodeling/restructuring of the internal lumen of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.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.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter tilted & embedded in ivc wall; all struts penetrate ivc wall into pericaval/mesenteric fat; one strut penetrated wall of aorta, embedded; one strut in contact with lumbar vertebra.The patient has reported that they have had to start seeing a therapist because of experiencing panic attacks which include shortness of breath, extreme dread, fear of dying, racing heart, palpitations, skipping heart beats, depression, trouble sleeping, no motivation, tired, sad and fearful.The indication for the filter implant was a history of multiple deep vein thrombosis (dvt), pulmonary embolism and morbid obesity.It was noted also that the patient required further surgery, unspecified.The filter was placed via the right femoral vein and deployed between the l2-l3 interspace.There were no reported complications and the patient was taken to recovery in satisfactory condition.There is currently no additional information available for review.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.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, embedding the device within the inferior vena cava (ivc) wall.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 tilt and perforation could not be confirmed, and the exact causes could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.Vessel perforation is a known adverse event associated with vena cava filters and is 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.The timing and mechanism of the tilt and perforation has not been reported at this time and 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.Without procedural films or images for review the reported event(s) could not be confirmed.Anxiety does not represent a device malfunction but may be related to underlying patient specific issues, the patient¿s medical history has not been provided.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.

Manufacturer Narrative

According to the information received in the patient profile from (ppf), the patient became aware of the alleged failures eleven years and eight months post implantation.The filter has not been attempted to be retrieved.The patient states that they have had to start seeing a therapist because she is having panic attacks which include shortness of breath, extreme dread, fear of dying, racing heart, palpitations, skipping heart beats, depression, trouble sleeping, no motivation, tired, sad and fearful.The following additional information received per the medical records state that the patient has a history of deep venous thrombosis, pulmonary emboli, and morbid obesity.During the implant procedure, sonosite was used with ultrasound guidance to access the right femoral vein.The seldinger technique was used for access and glide wire was placed.L-2/3 interspace was marked with fluoroscopy guidance.A vena cavagram with power injector was shot and the renal veins were identified.The ivc filter was then deployed between the l-2/3 interspace.The catheter was withdrawn and pressure was held on the groin.The patient was taken to the recovery room in satisfactory condition.

• Brand Name: 466P306AU
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 7675035
• MDR Text Key: 113581360
• Report Number: 1016427-2018-01633
• 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: 09/13/2018

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 Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0905591
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2018
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 07/11/2018; 07/11/2018
• Supplement Dates FDA Received: 07/27/2018; 09/10/2018; 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 48 YR