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

Catalog Number UNKFILTER

Device Problems Failure to Align (2522); Migration (4003)

Patient Problem Perforation (2001)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

As reported, on or about 2013, the patient underwent a surgical procedure to implant a cordis filter for the treatment and prevention of blot clot related issues.This hospital has since closed.The device in the patient was positively identified in a scan and subsequent evaluation taken.The patient received a scan.The scan noted that the patients filter had extended beyond the luminal margin.Subsequent evaluation of the images confirmed the filter had tilted and there was perforation of the patient¿s inferior vena cava.As a result of the malfunction of the cordis filter, the patient has suffered from and will continue to suffer from permanent and life-threatening injuries, requiring extensive medical care and treatment.He is currently in a weakened and susceptible state for future injuries.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The inferior 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.Without procedural films for review, the reported filter tilt and perforation of the ivc could not be confirmed.The timing and mechanism of the tilt has not been reported at this time.The brief also reported perforation of the ivc; however, 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.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 brief, on or about 2013, the patient underwent a surgical procedure to implant a cordis filter for the treatment and prevention of blot clot related issues.This hospital has since closed.The device in the patient was positively identified in a scan and subsequent evaluation taken.The patient received a scan.The scan noted that the patients filter had extended beyond the luminal margin.Subsequent evaluation of the images confirmed the filter had tilted and there was perforation of the patient¿s inferior vena cava.As a result of the malfunction of the cordis filter, the patient has suffered from and will continue to suffer from permanent and life-threatening injuries, requiring extensive medical care and treatment.He is currently in a weakened and susceptible state for future injuries.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.

Manufacturer Narrative

After further review of additional information received the following sections a2, a3, b5, g4, g7, h2, and h6 have been updated accordingly.Event: addendum for additional information received: the following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged events fifty-eight months and five days post implantation.The filter is noted to have migrated and that the patient is suffering mental anguish.According to the information in the medical records, approximately four years and nine months post implantation the patient underwent a computerized tomography (ct) scan of the abdomen.The impression per the radiologist reading of the ct scan are the following: the presence of the filter was described without evidence of a fracture.There was mild aneurysmal dilatation involving the infrarenal abdominal aorta with suspected, partial intraluminal thrombus.The infrarenal aneurysm measured 4.3 cm in length and 3.1 cm in transverse diameter.There was a hypodense lesion involving the right lobe of the liver measuring 1cm in diameter which may represent a simple cyst or hemangioma.Status post cholecystectomy without biliary ductal dilatation.There was also a prominence involving the descending colon which may represent incomplete distention.Colitis an infiltrative neoplastic process are considered less likely.It was reported that a patient underwent placement of a cordis filter for the treatment and prevention of blot clot related issues.The information provided indicated that the filter perforated the inferior vena cava (ivc), tilted, migrated and the patient has experienced anxiety.According to the medical records approximately four years and nine months post implant the patient underwent a computerized tomography (ct) scan of the abdomen.The results of the scan indicated that there is placement of an inferior vena cava filter with the apex approximately 1 cm superior to the right renal vein.Portions of the inferior vena cava filter extend beyond the luminal margin seen on series 2, image 31 but no abnormal attenuation consistent with chronic leaking is identified.The filter is angulated relative to the long axis of the inferior vena cava.No fracture of the filter or extension into the abdominal aorta is identified.The patient¿s medical history and procedural details 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.An inferior 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.The timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.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 a long-term and a procedural complication associated with ivc filters, however a positive product identification has not been provided.It is unknown if the tilt contributed to the reported perforation.The timing and mechanism of the migration has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (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 inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.With the limited information provided it is not possible to confirm or further clarify the reported events or make a determination as to any contributing factors.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7268077
• MDR Text Key: 99980964
• Report Number: 9616099-2018-01872
• Device Sequence Number: 1
• Product Code: DQO
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR