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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK)

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CORDIS CORPORATION OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK) Back to Search Results
Catalog Number 466F210A
Device Problems Filter (816); Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Device Markings/Labelling Problem (2911)
Patient Problem No Code Available (3191)
Event Date 07/08/2013
Event Type  Injury  
Manufacturer Narrative

This device remains implanted and is not available for evaluation. Additional information is pending and will be submitted within 30 days upon receipt. Please note that there is no code available for device use error.

 
Event Description

As reported by the legal department, an optease filter was introduced to the suprarenal position for upper right extremity thrombosis in pregnancy before childbirth by section. Approximately 2 months later, there was an unsuccessful attempt to remove it by the same physician. After sudden deterioration of her health condition, the patient was hospitalized. It was the opinion of the legal representative that the healthcare facility introduced a defective caval filter in an incorrect manner, i. E. Direction, and subsequently the facility proceeded incorrectly in the attempt to extract it, which led to the subsequent impossibility to remove the temporal caval filter and the necessity to leave it in the patient's body. In was further thought that the fault is the launch of distribution of an incorrectly labelled caval filter and subsequently its supply to the healthcare facility. Upon recommendation of a radiologist, the filter was kept in situ with subsequent anticoagulation treatment for thrombophilia with the risk of pulmonary embolism. Skiascopy and skiagraphy of the vena cava filter two years later indicate "the optease vena cava filter was implanted to the suprarenal position (due to the thrombosis in the right leg during pregnancy). The filter is defective in that the orientation of the extraction hook is reversed and it is in the same direction as the fixation hooks of the filter. Therefore the filter cannot be extracted by capturing the extraction hook. Now, 2 years after the implantation, the filter is most probably incorporated into the wall and the extraction by the jugular access is excluded due to the risk of rupture of the vena cava inferior. Situation after the implantation of the optease vena cava filter to the suprarenal position without any signs of dislocation or perforation. Note: a defective filter with incorrectly oriented hook. " the plaintiff has become aware of the true state and condition as late as with an almost two-year delay when she permanently undergoes powerful anticoagulant therapy, having the temporal caval filter placed in her body, with the caval filter probably incorporated in the vascular wall with a high-risk option of removal by operation, which may result even in the death of the plaintiff. The plaintiff suffers from anxiety, psychological disorders, shortness of breath, pains and her overall health condition is not good.

 
Manufacturer Narrative

The alert date of the previous report was 09/20/2015. However, the correct date is 09/03/2015. No additional corrections required at this time.

 
Manufacturer Narrative

As reported, an optease filter was introduced to the suprarenal position for upper right extremity thrombosis in pregnancy before childbirth by section. Approximately 2 months later, there was an unsuccessful attempt to remove it by the same physician. After sudden deterioration of the patient¿s health condition, the patient was hospitalized. It suggested that the healthcare facility introduced a ¿defective¿ caval filter in an incorrect manner, i. E. Direction, and subsequently the facility proceeded incorrectly in the attempt to extract it, which led to the subsequent impossibility to remove the temporal caval filter and the necessity to leave it in the patient's body. In was further thought that the fault is the launch of distribution of an incorrectly labelled caval filter and subsequently its supply to the healthcare facility. Upon recommendation of a radiologist, the filter was kept in situ with subsequent anticoagulation treatment for thrombophilia with the risk of pulmonary embolism. Skiascopy and skiagraphy of the vena cava filter two years later indicate ¿the optease vena cava filter was implanted to the suprarenal position (due to the thrombosis in the right leg during pregnancy). The filter is defective in that the orientation of the extraction hook is reversed and it is in the same direction as the fixation hooks of the filter. Therefore the filter cannot be extracted by capturing the extraction hook. Now, 2 years after the implantation, the filter is most probably incorporated into the wall and the extraction by the jugular access is excluded due to the risk of rupture of the vena cava inferior. Situation after the implantation of the optease vena cava filter to the suprarenal position without any signs of dislocation or perforation. ¿ the patient has become aware of the true state and condition as late as with an almost two-year delay when she permanently undergoes powerful anticoagulant therapy, having the temporal caval filter placed in her body, with the caval filter probably incorporated in the vascular wall with a high-risk option of removal by operation, which may result even in the death of the patient. The patient suffers from anxiety, psychological disorders, shortness of breath, pains and her overall health condition is not good. The device was not returned for analysis. Review of lot 15751704 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. No defective units were rejected during the final assembly of this lot. No other issues were noted that were considered potentially related to the reported complaint. The reported ¿incorrect labeling¿, ¿inaccurate placement ¿ upside down¿ and ¿retrieval difficulty-unable to retrieve from vessel wall¿ could not be confirmed as the device was not returned for analysis nor were procedural films provided for review. The exact cause could not be determined. The cordis optease retrievable vena cava filter (retrievable filter) is designed for percutaneous delivery of a retrievable vena cava filter to the inferior vena cava (ivc). The instructions for use instruct, ¿according to the selected venous access site, determine which end of the storage tube (containing the filter) is to be placed into the sheath introducer hemostasis valve. This is indicated by the printed colored arrows and text (femoral: green; jugular/ antecubital: blue) on the storage tube. The arrow of the desired access site will point into the sheath introducer hemostasis valve. Place the appropriate end of the storage tube (containing the opteaser retrievable filter), as far as possible into sheath introducer hemostasis valve. ¿ the retrieval difficulty experienced by the costumer was most likely related to the length of time the filter was deployed in the patient. The ifu states that the indication is for up to 12 days. Usage of the product other than that indicated in the product's instructions 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. Based on the dhr there is no indication that there is a design or manufacturing process cause for the reported events; therefore, no corrective action will be taken at this time.

 
Manufacturer Narrative

Additional information was received that in a follow up hearing, the claimant changed its basic allegations. Now, she no longer claims that the filter had been introduced in the vein wrongly, in the opposite direction, due to allegedly misprinted arrows on the introducer tube (and therefore it could not / cannot be removed) but she claims that the retrieval hook on the filter is located in the same direction as fixation barbs preventing its migration (and therefore the filter cannot be pulled out). Additional information was also received from a 2013 doppler vein usg rle: the finding has improved considerably ¿ today only a very small residual wall thrombosis in vfc taking up less than 1/4 of the lumen, only in a short section ¿ approximately 1¿2 cm. This small flat thrombus is of slightly higher echogenicity ¿ i. E. Chronic. In my view this finding does not present a pe risk anymore (thus the cava filter extraction would probably be possible now) but of course it represents a risk with regard to potential relapse. Flow parameters are completely normal now. Higher in vie and lower in vfs there is also a morphological finding and compressibility is normal. Films have been provided for review and were submitted to an independent reviewer for evaluation. Additional information received will be submitted within 30 days upon receipt.

 
Manufacturer Narrative

Additional information was received that the filter fractured. New device code for this event is (b)(4). A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

 
Manufacturer Narrative

As reported, an optease filter was introduced to the suprarenal position for upper right extremity thrombosis in pregnancy before childbirth by section. Approximately 2 months later, there was an unsuccessful attempt to remove it by the same physician. After sudden deterioration of the patient¿s health condition, the patient was hospitalized. It suggested that the healthcare facility introduced a ¿defective¿ caval filter in an incorrect manner, i. E. Direction, and subsequently the facility proceeded incorrectly in the attempt to extract it, which led to the subsequent impossibility to remove the temporal caval filter and the necessity to leave it in the patient's body. In was further thought that the fault is the launch of distribution of an incorrectly labelled caval filter and subsequently its supply to the healthcare facility. Upon recommendation of a radiologist, the filter was kept in situ with subsequent anticoagulation treatment for thrombophilia with the risk of pulmonary embolism. Skiascopy and skiagraphy of the vena cava filter two years later indicate ¿the optease vena cava filter was implanted to the suprarenal position (due to the thrombosis in the right leg during pregnancy). The filter is defective in that the orientation of the extraction hook is reversed and it is in the same direction as the fixation hooks of the filter. Therefore the filter cannot be extracted by capturing the extraction hook. Now, 2 years after the implantation, the filter is most probably incorporated into the wall and the extraction by the jugular access is excluded due to the risk of rupture of the vena cava inferior. Situation after the implantation of the optease vena cava filter to the suprarenal position without any signs of dislocation or perforation. ¿ the patient has become aware of the true state and condition as late as with an almost two-year delay when she permanently undergoes powerful anticoagulant therapy, having the temporal caval filter placed in her body, with the caval filter probably incorporated in the vascular wall with a high-risk option of removal by operation, which may result even in the death of the patient. The patient suffers from anxiety, psychological disorders, shortness of breath, pains and her overall health condition is not good. Additional information received indicated that the claimant changed their basic allegations. She no longer claims that the filter had been introduced in the vein wrongly, in the opposite direction, due to allegedly misprinted arrows on the introducer tube (and therefore it could not / cannot be removed) but she claims that the retrieval hook on the filter is located in the same direction as fixation barbs preventing its migration (and therefore the filter cannot be pulled out). Additional information was also received from a 2013 doppler vein usg rle: ¿the finding has improved considerably ¿ today only a very small residual wall thrombosis in vfc taking up less than 1/4 of the lumen, only in a short section ¿ approximately 1¿2 cm. This small flat thrombus is of slightly higher echogenicity ¿ i. E. Chronic. In my view this finding does not present a pe risk anymore (thus the cava filter extraction would probably be possible now) but of course it represents a risk with regard to potential relapse. Flow parameters are completely normal now. Higher in vie and lower in vfs there is also a morphological finding and compressibility is normal. ¿ films were received. Review by an independent physician noted, ¿ scope: i have reviewed the (b)(6) (reference no. 12 c 212/2015-10) and the following information was provided: narrative summary and (2) cd with 3 studies. Opinion: the case in context is that of a pregnant female who developed a right lower extremity dvt and underwent placement of an ¿optease¿ removable ivc filter. Following pregnancy, an attempt to remove the device 2 months later was unsuccessful. Due to an unclear deterioration in her condition she was hospitalized and allegations of improper placement of the filter were raised. Anticoagulation was initiated and two years later in 2013 an attempt to remove the device was unsuccessful. The patient now has a host of new complaints, but there is no evidence for dvt and her risk of pe has been deemed low. Image 1: fluoroscopic image of a filter in place. Image 2: ct scan documenting the ¿optease¿ ivc filter in the location of the intra hepatic ivc. Image 3: venography with attempted extraction of ivc filter. The device was 75% recaptured with only the cranial portion exposed and it appears to be well incorporated into the wall of the vena cava (fibrosis). The device was released and did not migrate but may have some fractures of the struts. The barbs appear to be oriented correctly and the device appears to have been placed correctly and in the appropriate direction. The intrahepatic location is somewhat high but depending on the extent of the right dvt is acceptable. There are some collaterals visible but the ivc remains patent with no obstruction. To summarize, the indication to implant the device during pregnancy with a documented dvt was appropriate. The device was correctly implanted with no apparent procedure related complications. The early failure to remove the device led to fibrosis, causing incorporation of the device into the wall of the ivc making the late retrieval unsuccessful. The ¿barbs to prevent migration¿ appear to be correctly oriented. Excessive force now to remove the device may result in laceration of the vessel and pose a risk that should be avoided. Chronic anticoagulation to prevent occlusion of the ivc is warranted. The device does not show any signs of manufacturing defect. The possible strut fractures may be associated repeated attempts to remove it. Finally, there is no evidence of migration and symptoms due to the presence of an ivc filter without occlusion (the case here) of the ivc are unusual. ¿ the device was not returned for analysis. Review of lot 15751704 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. No defective units were rejected during the final assembly of this lot. No other issues were noted that were considered potentially related to the reported complaint. The customer initially reported ¿incorrect labeling¿ and ¿inaccurate placement ¿ upside down¿ which could not be confirmed and the allegation was later changed to report that the ¿retrieval hook on the filter is located in the same direction as fixation barbs. ¿ review of procedural films by an independent physician did not confirm this report and noted that ¿the ¿barbs to prevent migration¿ appear to be correctly oriented¿. Review of the procedural films did, however, confirm retrieval difficulty and fracture of the filter. While the exact cause could not be conclusively determined, the length of time between filter implantation and retrieval attempts (at 2 months and 2 years) and procedural factors (¿the device was 75% recaptured with only the cranial portion exposed and it appears to be well incorporated into the wall of the vena cava (fibrosis). The device was released and did not migrate but may have some fractures of the struts¿) may have contributed to the reported retrieval difficulty and fracture of the device. Attempted retrieval beyond the indicated timeframe may lead to retrieval difficulty and 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. Given the 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.

 
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Brand NameOPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU
Type of DeviceTHROMBECTOMY SYSTEMS (DTK)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5052288
MDR Text Key24879935
Report Number9616099-2015-00409
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeEZ
PMA/PMN NumberK023116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2015
Device Catalogue Number466F210A
Device LOT Number15751704
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/29/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/02/2015 Patient Sequence Number: 1
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