| Catalog Number UNKNOWN |
| Device Problems
Malposition of Device (2616); Activation Problem (4042)
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| Patient Problem
Perforation of Vessels (2135)
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| Event Date 07/17/2015 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Corrected data compared with medwatch report mw5087373: adverse event: adverse and product problem.Outcomes to adverse event: life threatening.Date of report: 18jun2019.Initial reporter: (b)(6).Initial reporter also sent report to fda: yes.Mfr contact: (b)(4).Investigation is still in progress.[(b)(4), medwatch 5087373].
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Event Description
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Description of event according to initial reporter: "ivc filter did not deploy at the correct time, causing it to deploy into a lumbar vein".Brand: cook celect platinum vena cava filter.Patient outcome: unknown.
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Additional information received 22aug2019: filter implanted on (b)(6) 2015."the right common femoral vein was evaluated with ultrasound and seen to be patent, compressible, and free of clot.Under real time sonographic guidance, the left common femoral vein was accessed with micropuncture needle and a microwire and microsheath were inserted.A permanent sonographic image was obtained and placed in the patient's chart for documentation purposes.An inferior venacavogram was performed through the microsheath, which demonstrated patency of the right common iliac vein and patency of the inferior vena cava.A wire from another manufacturer was advanced through the inferior vena cava to the right atrium.The microsheath was exchanged for a 10-french sheath, which was advanced to the level of the renal veins.Through this sheath, a cook celect filter was deployed.The filter did not fully expand.The sheath was retracted and contrast was injected through the sheath demonstrating position within a lumbar vein.The sheath was retracted through the common iliac vein.A repeat an inferior venacavogram was performed demonstrating patency of the right common iliac vein and the ivc.The sheath was readvanced over a wire from another manufacturer within the inferior vena cava to the level of the renal veins.Subsequently, a retrievable cook celect filter was deployed below the level of the renal veins.Subsequent inferior venacavogram was performed demonstrating patency of the vena cava without evidence of contrast extravasation.The sheath was removed and hemostasis achieved with manual compression".Additional information recieved 23aug2019: [patient] has had imaging done for other purposes where the filters show up but never specifically to compare original placement and current location." patient outcome: additional information recieved 22aug2019: the patient tolerated the procedure well.
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Event Description
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Additional information provided on 27sep2019: the 1st visit with the [hospital] was (b)(6) 2015.The visit with the cardiologist was earlier as after talking with him we thought we should go to a larger facility for advice.It would take a lot more digging to get the exact date [the patient] saw the cardiologist but would have been between the time [the patient] had the filter put in and the visit to the [hospital].
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Summary of investigational findings: the investigation is based on the event description and an image review.It was reported that a celect-pt filter was deployed in a lumbar vein and a second filter was correctly placed below renal veins.Both filters are still in situ without any reported harm to the patient.Very poor quality fluoroscopic image from time of ivc filter placement demonstrates 2 ivc filters adjacent to the l2 vertebral body.The ivc filter within the ivc demonstrates 1 degree of rightward tilt relative to the vertebral bodies.The primary filter legs are difficult to evaluate given the low quality of the image, but appear to be expanded to approximately 23 mm.Just to the right of this ivc filter is an additional ivc filter with a parallel orientation.This ivc filter is not expanded and the maximal distance between the primary filter legs measures approximately 4 mm.The radiology report states the filter was deployed within a lumbar vein, however, this cannot be confirmed on the single image submitted for review.Both filters were deployed via a femoral approach.The radiology report describes an inferior venacavogram was performed through a microsheath that demonstrated patency of the right common iliac vein and ivc.This statement suggests that the microsheath was positioned in the right external/common iliac vein and an injection was performed from this location.A bentson wire was then reportedly advanced to the level of the right atrium and the sheath was exchanged for the deployment sheath of the celect platinum ivc filter.Since the deploying physician did not perform a repeat venogram to confirm that the deployment sheath was in the appropriate location, the physician proceeded to deploy the ivc filter in an extracaval location, presumably a lumbar vein.This complication could have been avoided by either using a diagnostic catheter through deployment sheath initially positioned in the ivc to perform the inferior venocavagram and/or repeating a venogram through the deployment sheath to confirm appropriate location for ivc filter deployment prior to deploying the filter.Since this ivc filter is not in the appropriate location, if it is possible to approach the filter hook via a jugular approach, retrieval of this filter should be considered.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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