MAUDE Adverse Event Report: CORDIS CORPORATION 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Fracture (1260)

Patient Problems Perforation (2001); Thromboembolism (2654)

Event Date 12/04/2013

Event Type  Injury  

Manufacturer Narrative

The catalog code provided (466p306x), represents an unknown trapease filter.The catalog and lot numbers for the actual product used in the procedure are unknown.    complaint conclusion: as reported via a legal brief, a patient underwent placement of a cordis trapease vena cava filter on or about (b)(6) 2011.The device subsequently malfunctioned by, inter alia, fracturing, embolizing, and perforating his vena cava.As a result of these malfunctions, plaintiff has suffered life-threatening injuries and damages and requires extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses.  the product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.    without return of the device or procedural films/ pictures for review, the reported filter fracture, embolism and vessel perforation could not be confirmed and the exact cause of the difficulty experienced by the customer could not be determined.Filter fracture and vessel injury are known complications of ivc filters and are listed in the ifu as such.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to the fracture and migration of ivc filters.The instructions for use also notes that 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.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 plaintiff underwent placement of a cordis trapease vena cava filter on or about (b)(6) 2011 at (b)(6) medical center in (b)(6).The device subsequently malfunctioned by, inter alia, fracturing, embolizing, and perforating his vena cava.As a result of these malfunctions, plaintiff has suffered life-threatening injuries and damages and requires extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses.

Manufacturer Narrative

As reported, the patient underwent placement of a cordis trapease inferior vena cava (ivc) filter.The device subsequently malfunctioned by fracturing, embolizing, and perforating the ivc.The indication for filter placement is not available.Per the patient profile form (ppf), the filter migrated and there was perforation outside of the ivc from the filter struts.The patient thought he had a greenfield filter but later learned it was a cordis filter.A follow up radiologic examination 2 2/3 years after filter placement indicated ¿there is a greenfield filter in the distal inferior vena cava with some of the struts broken; however, the implanted device is a cordis trapease device.The patient has anxiety.The filter remains implanted; thus, unavailable for analysis.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 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 instructions for use (ifu) states 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.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 includes 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.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.It was also 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.Blood clots and thrombosis within the filter and vasculature do not represent a device malfunction.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.

Manufacturer Narrative

As reported in the legal brief, the patient underwent placement of placement of a cordis trapease vena cava filter.The device subsequently malfunctioned by, inter alia, fracturing, embolizing, and perforating his vena cava.As a result of these malfunctions, the patient has suffered life-threatening injuries and damages and requires extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses.Additional information was received from the patient profile form that the filter migrated and there was perforation outside of filter struts outside of the ivc.The patient has experienced pain and suffering, including mental anguish regarding lifetime of risk of injury of a defective device.The patient must undergo periodic imaging to monitor the device which has and will expose him to substantial radiation.The patient thought he had a greenfield filter but later learned it was a cordis filter.A follow up radiologic examination 2 2/3 years after filter placement indicated ¿there is a greenfield filter in the distal inferior vena cava with some of the struts broken.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• MDR Report Key: 6244712
• MDR Text Key: 64579670
• Report Number: 1016427-2017-00152
• 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,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/20/2016
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: 03/29/2018; 04/27/2018
• Supplement Dates FDA Received: 04/27/2018; 05/04/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR