MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately eleven years post implantation.The patient further reports mental anguish and fear that the filter might cause further damage as it has not yet been safely removed.The indication for filter placement was chronic recurrent pulmonary embolism (pe) despite adequate anticoagulation or contraindication to anticoagulation.Past medical history includes acute renal failure, congestive heart failure, chronic fatigue syndrome, deep vein thrombosis (dvt), myocardial infarction (mi), pancreatitis, pleurisy, hypertension and raynaud¿s disease.Surgical history includes inferior vena cava filter (ivc filter), hysterectomy, bilateral hip replacements and medi-port placement.A ct scan of the abdomen done approximately eleven years post implant, revealed the ivc filter is present.The most posterior strut appears to perforate the posterior margin of the ivc and approaches the anterior periosteum of the l2 vertebral body.There was no additional evidence of ivc filter complication.Per the medical records, the patient presented with mid-back pain with radiation down the legs.A physician consult regarding back pain and possible filter removal states the very minimal filter perforation may not be causing the patient¿s back pain and the filter is a trapease and would require an open surgical procedure for removal.The physician did not recommend removal as the benefit would likely not outweigh the risks.

Manufacturer Narrative

Complaint conclusion: as reported, the patient had placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement was chronic recurrent pulmonary embolism (pe) despite adequate anticoagulation or contraindication to anticoagulation.Past medical history includes acute renal failure, congestive heart failure, chronic fatigue syndrome, deep vein thrombosis (dvt), myocardial infarction (mi), pancreatitis, pleurisy, hypertension and raynaud¿s disease.Surgical history includes inferior vena cava filter (ivc filter), hysterectomy, bilateral hip replacements and medi-port placement.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of the vena cava.Per the patient profile form (ppf), the patient reports mental anguish and fear.A ct scan of the abdomen done approximately 11 years post implant, revealed the most posterior strut appears to perforate the posterior margin of the ivc and approaches the anterior periosteum of the l2 vertebral body.There was no additional evidence of ivc filter complication.Per the medical records, the patient presented with mid-back pain with radiation down the legs.A physician consult regarding back pain and possible filter removal states the very minimal filter perforation may not be causing the patient¿s back pain and the filter is a trapease and would require an open surgical procedure for removal.The physician did not recommend removal as the benefit would likely not outweigh the risks.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.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.Anxiety and 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.

Event Description

As reported by the legal department, 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, perforation of the vena cava.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately eleven years post implantation.The patient further reports mental anguish and fear that the filter might cause further damage as it has not yet been safely removed.The indication for filter placement was chronic recurrent pulmonary embolism (pe) despite adequate anticoagulation or contraindication to anticoagulation.Past medical history includes acute renal failure, congestive heart failure, chronic fatigue syndrome, deep vein thrombosis (dvt), myocardial infarction (mi), pancreatitis, pleurisy, hypertension and raynaud¿s disease.Surgical history includes inferior vena cava filter (ivc filter), hysterectomy, bilateral hip replacements and medi-port placement.A ct scan of the abdomen done approximately 11 years post implant, revealed the ivc filter is present.The most posterior strut appears to perforate the posterior margin of the ivc and approaches the anterior periosteum of the l2 vertebral body.There was no additional evidence of ivc filter complication.Per the medical records, the patient presented with mid-back pain with radiation down the legs.A physician consult regarding back pain and possible filter removal states the very minimal filter perforation may not be causing the patient¿s back pain and the filter is a trapease and would require an open surgical procedure for removal.The physician did not recommend removal as the benefit would likely not outweigh the risks.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8436459
• MDR Text Key: 139327633
• Report Number: 1016427-2019-02632
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• 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
• Report Date: 04/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: R0207128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR
• Patient Weight: 70