MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

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

Patient Problems Embolus (1830); Occlusion (1984); Swelling (2091); Perforation of Vessels (2135)

Event Date 03/14/2008

Event Type  Injury  

Manufacturer Narrative

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, the filter was significantly tilted and approximately 6 struts had significantly perforated the ivc and into adjacent organs including the duodenum.The patient had undergone an updated computerized tomography (ct) scan approximately nine years post implant that identified the reported issues.It was also reported that the patient, as a direct and proximate result of these malfunctions, has 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.There is currently no additional information available.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.Vessel perforation is a known adverse event associated with implanting 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 the procedural films or post-placement imaging and the limited information provided, the report of tilt and perforation of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.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.Given the limited information currently available for review, 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.

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, the filter was significantly tilted and approximately 6 struts had significantly perforated the ivc and into adjacent organs including the duodenum.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

After further review of additional information received, the following sections have been updated accordingly.Additional information received per the medical records indicate that the patient has a history of morbid obesity.After deployment, a venacavagram of the inferior vena cava revealed that the filter was centered at the tip of the hemostatic level.Additional information received per the patient profile form (ppf) states that the patient became aware of the alleged filter failures approximately nine years and six months after the index procedure.It was reported that the filter fractured and that the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava.Additionally, the patient experienced stomach pain, leg pain, leg swelling, fear and anxiety.The form also states that the patient experienced depression which caused her to lose her appetite, made it hard to bathe and caused her social life to suffer (social life is not very good).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, the filter was significantly tilted and approximately 6 struts had significantly perforated the ivc and into adjacent organs including the duodenum, the filter fractured and the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava, stomach pain, leg pain, leg swelling, fear and anxiety.The form also states that the patient experienced depression which caused her to lose her appetite, made it hard to bathe and caused her social life to suffer.The medical records indicated that the patient has a history of morbid obesity.The indication for the filter placement and the procedural details were not provided.Two digital spot images of an inferior vena cava filter (ivc) placement were submitted to the radiology department at the implant facility for review.The findings of the spot images noted that the first image demonstrates hemostats projecting over the patient and adjacent of the ivc which is partially opacified.A catheter is also noted to be present over the lower portion of the ivc.The second image demonstrates post deployment of a trapease vena cava filter centered to the tip of the hemostat level.The information provided indicated that the patient became aware of the alleged filter failures approximately nine years and six months after the index procedure.How the alleged failures were identified or the mechanism by which they were communicated to the patient have not been provided.There is currently no additional information available for review.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.Blood clots and occlusive thrombosis within the filter do not represent a device malfunction.Without images or procedural films for review, the reported filter tilt, perforation and fracture could not be confirmed, and the exact causes could not be determined.The timing and mechanism of the tilt has not been reported at this time.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 implanting 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.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.Anxiety, depression, leg swelling, and stomach and leg pain 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: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7542398
• MDR Text Key: 109220422
• Report Number: 1016427-2018-01483
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/25/2018
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 54 YR