MAUDE Adverse Event Report: CORDIS CASHEL 466P306AU; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306AU

Device Problems Fracture (1260); Failure to Align (2522); Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135)

Event Date 07/26/2019

Event Type  Injury  

Event Description

As reported an additional legal brief, the patient underwent placement of a trapeasevena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation abutting an organ, fracture, migration, tilt, and perforation that caused injury and damage to the patient.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapeasevena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation abutting an organ, fracture, migration, tilt, and perforation that caused injury and damage to the patient.The patient reported fracture, perforation of filter strut(s) outside the ivc, migration of entire filter other than to heart, tilt, and perforation abutting an organ, anxiety and becoming aware of the events twelve years and two months post implant.The indication for the filter placement was a history of chronic deep vein thrombosis and was awaiting surgery for a right knee replacement.The filter was placed via the left common femoral vein and deployed in the infrarenal location with the apex of the filter at the inferior endplate of the l1 vertebral body level.The patient tolerated the procedure well.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 pe via percutaneous placement in the 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 filter tilt, migration, fracture and ivc perforation events could not be confirmed or clarified and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Additionally, the timing and mechanism of the events is unknown.The instructions for use (ifu) states that 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.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the ivc including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.It is unknown if the tilt contributed to the reported perforation.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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.

Manufacturer Narrative

According to the information received in the patient profile from (ppf), the patient became aware of the reported events twelve years and two months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture, perforation of filter strut(s) outside the ivc, migration of entire filter other than to heart, tilt, and perforation abutting an organ.The patient also reports anxiety.The following additional information received per the medical records state that the patient has a history of chronic dvt.During the implant procedure, the left common femoral vein was accessed.The filter was deployed in an infrarenal location.The apex of the filter was at the inferior endplate of the l1 vertebral body level.

• Brand Name: 466P306AU
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9272269
• MDR Text Key: 164870940
• Report Number: 1016427-2019-03488
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0207487
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR