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

Catalog Number 466P306X

Device Problems Obstruction of Flow (2423); Output Problem (3005)

Patient Problems Coagulation Disorder (1779); Perforation (2001); Perforation of Vessels (2135); Obstruction/Occlusion (2422)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 perforation and occlusion.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 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.Occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological 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.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to occlusion and perforation.

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 inferior vena caval perforation, inferior vena caval occlusion, clotting and anxiety.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 reported ¿inferior vena caval occlusion, inferior vena cava perforation, clotting and anxiety¿ could not be confirmed as the device was not returned.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 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.Clotting or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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

Additional information received per the medical records state that prior to filter implantation the patient had an open reduction and internal fixation of a complex pelvic fracture.The patient was hemodynamically compromised and had experienced shock.Transesophageal echo was performed at the bedside, showing right heart dilatation and thrombus was seen in the pulmonary artery.The patient underwent pulmonary thromboembolictomy with removal of clot.It was determined that the patient would likely not receive full anticoagulation due to the complexity of his injuries.Post pulmonary embolectomy the vena cava filter was implanted via an indwelling 9 french right internal jugular vein catheter.A 5 french pigtail catheter was advanced into the inferior vena cava under direct fluoroscopic guidance.The filter was deployed in the infrarenal position with good alignment.The patient tolerated the procedure well.  additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting and/or occlusion of the ivc.The patient became aware of the reported events approximately seventeen years and four months after the index procedure.The patient continues to experience anxiety related to the filter.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12678199
• MDR Text Key: 277854998
• Report Number: 9616099-2021-04987
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Patient Sequence Number: 1
• Treatment: CORDIS SHEATH, INTRODUCER AND DILATOR; UNKNOWN 5 FRENCH PIGTAIL CATHETER; UNKNOWN 9 FRENCH RIGHT INTERNAL JUGULAR VEIN CATHE; UNKNOWN 9 FRENCH SHEATH; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Life Threatening