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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Filter (816); Difficult to Remove (1528); Device Markings/Labelling Problem (2911)
Patient Problems Pain (1994); Thrombosis (2100)
Event Date 07/13/2010
Event Type  Injury  
Manufacturer Narrative

Please note that this report is being submitted due to a system issue/new quality system being used. The report was previously submitted in our previous quality system/ onevoice under complaint # (b)(4), # 9616099-2015-00250.   please note that catalog # 466fxxxx represents an unknown optease filter. The actual catalog and lot # are unknown at this time. This is the initial/final report for this file.   concomitant products: folic acid, lovenox, metoprolol tartrate, multaq, protonix, alprazolam, lortab, neurontin. Enoxaparin, hydrocodone/acetaminophen , metoprolol succinate , nitroglycerine, zetia, simvastatin, clonidine. Additional information was received: procedure notes: the right groin was prepped and draped usual sterile fashion. Local anesthesia was achieved using 2% lidocaine mixed with sodium bicarbonate. The right common femoral vein was accessed under ultrasound guidance using a micropuncture kit. Using a seldinger technique, a optease sheath was advanced into the inferior vena.  inferior venacavagrarn was performed noting the size of theinferior vena cava and the level of the renal veins. The trapease filter was deployed under fluoroscopic guidance without difficulty. Follow-up vena cava gram was performed demonstrating satisfactory position. The sheath was removed. Manual compression was performed. Successful placement of a optease filter with positioning in the inferior vena cava to achieve hemostasis. The patient tolerated the procedure well. There were no immediate complications.   removal of thrombus in filter: the trapease filter remains in place with an unusual appearance in its lateral aspect suggesting the presence of mural thrombus. After the thrombus plug in the caudate end of the filter was identified, an infusion catheter was introduced and positioned in the left common iliac vein, and in that location, infusion of tpa was begun. Contrast was injected through the infusion catheter with the catheter positioned in the left external iliac vein. Study of the affected site was performed. After completion of that study, a guidewire was introduced, and over a guidewire, an angiojet device was introduced. Angiojet thrombectomy was performed of residual thrombus within the filter as well as adherent to the lateral wall of the common iliac vein. That procedure was successful in removing all of the thrombus from the lateral wall of the iliac vein, and also was successful in removing the ball, but not all of the thrombus within the filter. After completion of these procedures, and demonstration of rapid antegrade flow through the filter, it was elected to discontinue the procedure. At this point, it was noted the patient had altered his cardiac rhythm from a sinus rhythm to atrial fibrillation. The cause of this change is not immediately apparent. The patient will be studied with ekg and with cardiac consult shortly. He is stable and in no distress at this time. After completion of the procedure, the sheath placed in his left popliteal vein was removed and hemostasis was obtained without difficulty. The patient was given 3000 units of heparin during the procedure. No further tissue plasminogen activator therapy or thrombectomy therapies anticipate at this time. It is anticipated, however, the patient will undergo removal of this filter, possibly substitution alternative filter in the near future, after recovery from the current procedures, i. E. 10 days, 2 weeks.  first attempt to remove filter: patient has an optease filter just above the bifurcation.  no notable filling defects. Originally, the 10 french sheath supplied with the cook retrieval set was set up to the inferior apex of the filter and attempts were made to grasp the hook. This was unsuccessful and therefore a 0. 035 glidewire was advanced across the distal strut and snared utilizing a 14 french sheath.  the 14 french sheath was then able to be maneuvered across the filter and the distal one half of the filter was able to be collapsed into the sheath but could not collapse the superior half fully within the sheath for complete capture. Two different attempts were made. Decision was made to terminate the procedure after these two attempts. Completion angiogram showed persistent patency of the ivc. No extravasation. Sheath was removed. Hemostasis was achieved at the puncture site. The patient tolerated the procedure without any immediate complications.  medical note: the patient has a history of severe bilateral deep venous thrombosis.  he had an ivc filter placed. There has been one previous attempt of removal that has failed. He comes now for a second attempt. At the, time of admission, d-dimer 0. 23, sgot 97, sgpt 158, amylase 46, inr 1. 1. White blood cell count 7. 3 with hemoglobin and hematocrit of 13. 1 and 36. 8, platelets 140,000. Glucose 136. On (b)(6) 2011, dr. (b)(6) attempted to remove the ivc filter. He notes that the initial cavogram demonstrated a small amount of residual thrombus and/or intimal hyperplasia encasing the left-sided leg of the patient's previously placed optease filter. There is rapid flow through the filter. Attempts to remove the filter using snare technique both from above and below were unsuccessful. The filter removal procedure was complicated by thrombosis that occurred within the filter at the termination of the procedure. Catheter was left in place for tpa infusion and attempted to dissolve the acute thrombus. He felt that the completion of the further potential of removing that filter would require use of surgical techniques. Dr. (b)(6) followed up on the next day following tpa noting small residual filling defects within the filter, which would continue to autolyse with continued anticoagulation. The filling defects did not slow or obstruct the flow. On the day of discharge, the patient went for ct abdomen to evaluate his complain of pain. Ct abdomen notes a previous cholecystectomy and ivc filter placement. There was no acute process identified. During a procedure to identify cause of chest pain the patient presented with, it was noted that the optease filter was located "perfectly" located infrarenally without any evidence of migration. After two attempts: mr. (b)(6) is an unfortunate (b)(6) year-old gentleman who is incarcerated. He has had a history of deep venous thrombosis in the past and has undergone vena cava filter placement. This patient is currently incarcerated, but has been doing well prior to recent development of swelling in his legs where he was found to have extensive right lower extremity deep venous thrombosis. The patient was felt to require lytic therapy, so he was transferred from destin for further evaluation. It is possible to remove this vena cava filter, but it would need to be done with open operative technique and is not something that i would recommend unless there was a significant problem with the vena cava filter that is currently in place.  (b)(4). Updated complaint conclusion: as reported, due to incorrect labeling the optease filter was placed upside down.  multiple attempts were made to retrieve the optease with no success. The patient "will be forced to undergo additional invasive surgical procedures and has sustained permanent pain, suffering, disability, impairment, loss of enjoyment of life and economic damages. " the patient underwent a surgical operation whereby an optease retrievable vena cava filter was implanted. The optease filter was implanted for its intended purpose. Despite multiple attempts to remove the optease filter as intended, the patient's physicians have been unable to remove the optease filter to date. Due to inadequate and incorrect labeling, the optease filter was implanted in the incorrect direction, leading to complications, and it has been impossible to remove the optease filter to date. The patient will continue to undergo medical treatment and has undergone multiple unsuccessful surgical procedures.  additional information was received stating that on july 13, 2010, the optease filter was implanted. The right groin was prepped and draped as per usual sterile fashion.  the right common femoral vein was accessed under ultrasound guidance using a micropuncture kit. Using a seldinger technique, an optease sheath was advanced into the inferior vena cava. Inferior vena cavagrarn was performed noting the size of the inferior vena cava and the level of the renal veins. The optease filter was deployed under fluoroscopic guidance without difficulty. Follow-up vena cava gram was performed demonstrating satisfactory position. The sheath was removed.  manual compression was performed. A successful placement of an optease filter with positioning in the inferior vena cava was completed. The patient tolerated the procedure well. There were no immediate complications. A couple of weeks later, the patient had a procedure to remove thrombus in the optease. The optease filter remains in place with an unusual appearance in its lateral aspect suggesting the presence of mural thrombus. After the thrombus plug in the caudate end of the filter was identified, an infusion catheter was introduced and positioned in the left common iliac vein, and in that location, infusion of tissue plasminogen activator (tpa) was initiated. Contrast was injected through the infusion catheter with the catheter positioned in the left external iliac vein. Study of the affected site was performed.  after completion of that study, a guidewire was introduced, and over a guidewire, an angiojet device was introduced. Angiojet thrombectomy was performed of residual thrombus within the filter as well as adherent to the lateral wall of the common iliac vein. That procedure was successful in removing all of the thrombus from the lateral wall of the iliac vein, and also was successful in removing the ball, but not all of the thrombus within the filter. After completion of these procedures and demonstration of rapid antegrade flow through the filter, it was elected to discontinue the procedure. At this point, it was noted that the patient had altered his cardiac rhythm from a sinus rhythm to atrial fibrillation. The cause of this change is not immediately apparent. The patient will be studied with ekg and with a cardiac consult shortly. He is stable and in no distress at this time. After completion of the procedure, the sheath placed in his left popliteal vein was removed and hemostasis was obtained without difficulty. The patient was given 3000 units of heparin during the procedure. No further tissue plasminogen activator therapy or thrombectomy therapies anticipated at this time. It is anticipated, however, the patient will undergo removal of this filter, possibly substitution alternative filter in the near future, after recovery from the current procedures, i. E. 10 days, 2 weeks. The physician later decided to remove the filter.  the patient has an optease filter just above the bifurcation. No notable filling defects. Originally, the 10 french sheath supplied with the cook retrieval set was set up to the inferior apex of the filler and attempts were made to grasp the hook. This was unsuccessful and therefore a 0. 035" glidewire was advanced across the distal strut and snared utilizing a 14 french sheath. The 14 french sheath was then able to be maneuvered across the filter and the distal one half of the filter was able to be collapsed into the sheath but could not collapse the superior half fully within the sheath for complete capture. Two different attempts were made. Decision was made to terminate the procedure after these two attempts. Completion angiogram showed persistent patency of the ivc. No extravasation. Sheath was removed. Hemostasis was achieved at the puncture site. The patient tolerated the procedure without any immediate complications. There has been one previous attempt of removal that has failed. He comes now for a second attempt. At the time of admission, the d-dimer was 0. 23, sgot 97, sgpt 158, amylase 46, inr 1. 1. White blood cell count 7. 3 with hemoglobin and hematocrit of 13. 1 and 36. 8, platelets 140,000. Glucose is 136.   on (b)(6) 2011, dr. (b)(6) attempted to remove the ivc filter. He notes that the initial cavogram demonstrated a small amount of residual thrombus and/or intimal hyperplasia encasing the left-sided leg of the patient's previously placed optease filter. There is rapid flow through the filter. Attempts to remove the filter using a snare technique both from above and below were unsuccessful. The filter removal procedure was complicated by thrombosis that occurred within the filter at the termination of the procedure. Catheter was left in place for tpa infusion and attempted to dissolve the acute thrombus. He felt that the completion of the further potential of removing that filter would require use of surgical techniques. Dr.  (b)(6) followed up on the next day following tpa noting small residual filling defects within the filter, which would continue to autolyse with continued anticoagulation. The filling defects did not slow or obstruct the flow. On the day of discharge, the patient went for a ct of the abdomen to evaluate his complaints of pain. Ct abdomen notes a previous cholecystectomy and ivc filter placement. There was no acute process identified. During a procedure to identify the cause of chest pain the patient presented with, it was noted that the optease filter was located "perfectly" infrarenally without any evidence of migration. After the second attempt to remove the filter, the patient came into the hospital with swelling of the legs. The physician reports that the patient is an unfortunate (b)(6)-year-old gentleman who is incarcerated. He has had a history of deep venous thrombosis in the past and has undergone vena cava filter placement. This patient is currently incarcerated, but has been doing well prior to recent development of swelling in his legs where he was found to have extensive right lower extremity deep venous thrombosis. The patient was felt to require lytic therapy, so he was transferred from destin for further evaluation. It is possible to remove this vena cava filter, but it would need to be done with open operative technique and is not something that he would recommend unless there was a significant problem with the vena cava filter that is currently in place. The physician will await the results of the lytic therapy. A dhr could not be conducted as the sterile lot number was not provided. The device remains implanted in the patient and could not be analyzed nor was packaging components received for analysis. Without return of the device for analysis or films for review, the reported incorrect labeling, inaccurate placement and retrieval difficulty could not be confirmed and the exact cause could not be determined. Given the information available for review, a clinical conclusion between the device and the event could not be determined.  retrieval of the optease vena cava filter is indicated up to 23 days post implantation. Usage of the product other than that indicated in the product's instruction for use (ifu) may involve additional risks not described in the labeling.  the predominant concern is the development of endothelialization, which would make subsequent removal difficult. Endothelialization has been shown to lead to explantation problems after as short a period as 12 days. Should additional information be received, the file will be evaluated and processed accordingly.  without films for review or a dhr, there is no indication at this time that this event is related to the design or manufacturing process; therefore, no corrective action will be taken at this time.

 
Event Description

As reported by the law department, due to incorrect labeling the optease filter was placed upside down. Multiple attempts have been made to retrieve the optease with no success. The patient will be forced to undergo additional invasive surgical procedures and has sustained "permanent pain, suffering, disability, impairment, loss of enjoyment of life and economic damages. " the patient underwent a surgical operation whereby an optease retrievable vena cava filter was implanted into his body. The optease filter is a device was implanted for its intended purpose. Despite multiple attempts to remove the optease filter as intended, the patient's physicians have been unable to remove the optease filter to date. Due to inadequate and incorrect labeling, the optease filter was implanted in the incorrect direction, leading to complications, and it has been impossible to remove the optease filter to date. The patient will continue to undergo medical treatment and has undergone multiple unsuccessful surgical procedures. The patient will be forced to undergo additional invasive surgical procedures and has sustained "permanent pain, suffering, disability, impairment, loss of enjoyment of life and economic damages. "  .

 
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Brand Name466FXXXX
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
p.o. box 025700
miami FL 33152
Manufacturer (Section G)
CORDIS CORPORATION
p.o. box 025700
miami FL 33152
Manufacturer Contact
karla castro
14201 nw 60th ave.
miami lakes, FL 33014
MDR Report Key6547677
MDR Text Key74588173
Report Number1016427-2017-00297
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466FXXXX
Device Catalogue Number466FXXXX
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/12/2017
Event Location No Information
Date Manufacturer Received04/12/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/05/2017 Patient Sequence Number: 1
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