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

Model Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 09/27/2014

Event Type  Death  

Manufacturer Narrative

The lot number for the product is unknown and therefore no device history review (dhr) can be performed.

Event Description

As reported by the legal department, the decedent was implanted with the ivc filter at (b)(6) on or about (b)(6) 2012.After implantation the decedent died on (b)(6) 2014.Ivc filter that was implanted in decedent developed organized blood clots which became infected and traveled to his lungs; resulting in small vessel thrombi leading to extensive pulmonary infarction as evidenced by extensive pulmonary consolidation on radiology imaging, thereby leading to acute myocardial ischemia and, ultimately, death.On information and belief, these issues were brought on by the failure of the defendants' ivc filter to do what it was designed and marketed to do, prevent pulmonary embolism.Decedent's spouse, plaintiff, suffered mental pain and suffering as a direct and proximate result of decedent's injury and death.Moreover, because of decedent's severe injury from the ivc filter, plaintiff suffered a loss.

Manufacturer Narrative

Additional information was received regarding the procedure.As reported by the legal department, the patient was implanted with the ivc filter.After implantation the patient died.The ivc filter that was implanted in the patient developed organized blood clots which became infected and traveled to his lungs; resulting in small vessel thrombi leading to extensive pulmonary infarction as evidenced by extensive pulmonary consolidation on radiology imaging, thereby leading to acute myocardial ischemia and, ultimately, death.On information and belief, these issues were brought on by the failure of the defendants' ivc filter to do what it was designed and marketed to do, prevent pulmonary embolism.The patient's spouse, suffered mental pain and suffering as a direct and proximate result of patient's injury and death.Moreover, because of patient's severe injury from the ivc filter, the patient suffered a loss.During the initial procedure.The risks, benefits and alternatives of fluoroscopically guide ivc filter placement grossly the patient understood and wished proceed.The right groin was prepped and draped in sterile fashion 1% lidocaine utilized for local anesthesia to the skin and underlying soft tissue.A small neck was made in the skin with a scalpel and a 20-gauqe vascular needle advanced into the right femoral vein under ultrasound guidance.A 0.018 wire was advanced into the femoral vein and the needle removed.A 4 french introducer catheter a sheath was advanced over the wire and the introducer was removed.A 0.35 wire was advanced through the introducer sheath into the inferior vena cava.The sheath exchanged for a 6 french cordis introducer catheter sheath which was advanced over the wire to the level of the mid l2 vertebral body.The inner sheath and wire was removed and a venogram was performed.Ivc venogram: an ivc venogram was performed demonstrating the renal veins to exit at approximately t12-l2 on the right and l1 on the left with the bifurcation at the l5 level.The introducer catheter sheath was advanced over a 0.35 wire to the mid l2 vertebral body level and inner introducer catheter and wire removed.The cordis trapease inferior vane cava filter was advanced and placed with its cranial tip at the mid l2 vertebral body level and the cranial tip at the l3 level.The introducer and catheter or removed and hemostasis obtained at the groin puncture site.Patient tolerated procedure 'well with out immediate complication.Successful ivc filter placement.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.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.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication.Factors that may have influenced the event include patient, pharmacological and lesion.Myocardial infarction is a known potential adverse event associated with stent implantation procedures.The act of angioplasty/stent implantation inherently produces a localized vessel injury, including plaque compression and splitting, potentially leading to release of atheromatous material (lesion contents) into the downstream flow and potentially slowing or completely occluding the blood flow.The inflation of coronary devices also inherently occludes the distal blood flow, possibly creating ischemic areas (causing cardiac enzyme changes) distal to the target lesion.It is unknown at what point and how the patient was exposed to a bacterial pathogen.Infections resulting from invasive procedures are a well-known potential adverse event and are listed in the ifu as such.There are a multitude of possible etiologies and opportunities for the introduction of pathogens into the patient, however, at this time it is not possible to draw a clinical conclusion between the device and the event.The inherent risk of the procedure combined with the patient¿s complex medical status, vessel characteristics and procedural factors may have contributed to the event.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.

Manufacturer Narrative

Complaint conclusion: as reported, the patient was implanted with an unidentified cordis inferior vena cava (ivc) filter.The indication for filter was deep vein thrombosis (dvt) and pulmonary embolism (pe).During the implant procedure, a venogram was performed to locate the renal veins.The filter was deployed its cranial tip at the mid l2 vertebral body level and the cranial tip at the l3 level.The filter subsequently malfunctioned resulting in death.After implantation the patient developed organized blood clots which became infected and traveled to his lungs; resulting in small vessel thrombi leading to extensive pulmonary infarction as evidenced by extensive pulmonary consolidation on radiology imaging, thereby leading to acute myocardial ischemia and, ultimately, death.Medical conditions and treatments alleged to be attributable to the implanted ivc filter include death due to acute myocardial ischemia resulting from extensive pulmonary consolidation and small vessel thrombi, blood clots, dyspnea, lower extremity swelling and edema due to clotting in filter, and chest pain.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 cordis vena cava filters are 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.Blood clots, thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Infection is a known potential event associated to all device implantation procedures and maybe related to underlying patient conditions or surgical technique.Myocardial ischemia, with chest pain, and pulmonary infarction, associated to thrombosis with embolization, that lead to death are known potential adverse events associated with the use of the ivc filter devices.These events may be related to the underlying clotting issues that were the indication for filter placement.Extreme thrombus burden within the ivc and filter are known to contribute to embolization.Anxiety and pain do 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.

Event Description

As reported by the legal department, the patient was implanted with the ivc filter.After implantation the the patient died.The ivc filter that was implanted in the patient developed organized blood clots which became infected and traveled to his lungs; resulting in small vessel thrombi leading to extensive pulmonary infarction as evidenced by extensive pulmonary consolidation on radiology imaging, thereby leading to acute myocardial ischemia and, ultimately, death.On information and belief, these issues were brought on by the failure of the defendants' ivc filter to do what it was designed and marketed to do, prevent pulmonary embolism.The patient's spouse, suffered mental pain and suffering as a direct and proximate result of patient's injury and death.Moreover, because of patient's severe injury from the ivc filter, the patient suffered a loss.During the initial procedure.The risks, benefits and alternatives of fluoroscopically guide ivc filter placement grossly the patient understood and wished proceed.The right groin was prepped and draped in sterile fashion 1% lidocaine utilized for local anesthesia to the skin and underlying soft tissue.A small neck was made in the skin with a scalpel and a 20-gauqe vascular needle advanced into the right femoral vein under ultrasound guidance.A 0.018 wire was advanced into the femoral vein and the needle removed.A 4 french introducer catheter a sheath was advanced over the wire and the introducer was removed.A 0.35 wire was advanced through the introducer sheath into the inferior vena cava.The sheath exchanged for a 6 french cordis introducer catheter sheath which was advanced over the wire to the level of the mid l2 vertebral body.The inner sheath and wire was removed and a venogram was performed.Ivc venogram: an ivc venogram was performed demonstrating the renal veins to exit at approximately t12-l2 on the right and l1 on the left with the bifurcation at the l5 level.The introducer catheter sheath was advanced over a 0.35 wire to the mid l2 vertebral body level and inner introducer catheter and wire removed.The cordis trapease inferior vane cava filter was advanced and placed with its cranial tip at the mid l2 vertebral body level and the cranial tip at the l3 level.The introducer and catheter or removed and hemostasis obtained at the groin puncture site.Patient tolerated procedure 'well with out immediate complication.Successful ivc filter placement.According to the discovery form, medical conditions outlined include deep vein thrombosis (dvt) and pulmonary embolism (pe).Medical conditions and treatments alleged to be attributable to the implanted ivc filter include death due to acute myocardial ischemia resulting from extensive pulmonary consolidation and small vessel thrombi, blood clots, dyspnea, lower extremity swelling and edema due to clotting in filter, chest pain in addition to decedent¿s emotional distress, loss of enjoyment of life and other consequential damages as allowed by law.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• MDR Report Key: 6080454
• MDR Text Key: 59218157
• Report Number: 1016427-2016-00111
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2019

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?: No
• Device Operator: No Information
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/12/2016
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/04/2016
• Supplement Dates Manufacturer Received: Not provided; 10/23/2017; 06/24/2019
• Supplement Dates FDA Received: 12/12/2016; 11/21/2017; 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1