MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Defective Component (2292)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter was associated with mesenteric perforation.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 inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported ivc perforation could not be confirmed and the exact cause could not be determined.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, mesenteric perforation.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.

Manufacturer Narrative

According to the information received in the patient profile form (ppf), the patient became aware of the reported events thirteen years and eleven months post implant.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of filter strut(s) outside the ivc.The patient also reports anxiety, fear of death or damaged organs.The following additional information received per the medical records state that the patient has a was admitted with signs and symptoms consistent with peritonitis and some shortness of breath.The patient was evaluated and was found to have what appeared to be a pulmonary embolus, which was confirmed by a ct scan.The patient was implanted with an inferior vena cava filter.The patient tolerated the procedure well.

Manufacturer Narrative

As reported, a patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient was admitted with signs and symptoms consistent with peritonitis and shortness of breath.The patient was diagnosed with pulmonary embolus, confirmed by a ct scan.The patient was implanted with an inferior vena cava filter.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, mesenteric perforation.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc.The patient also reports anxiety, fear of death or damaged organs.The product was not returned for analysis.The dhr could not be completed.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 and organs; 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 does 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
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9749859
• MDR Text Key: 188381562
• Report Number: 1016427-2020-03861
• Device Sequence Number: 1
• Product Code: DTK
• 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
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• 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: 466P306AU
• Device Lot Number: R1103501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 48 YR