MAUDE Adverse Event Report: COOK INC UNKNOWN; KRD DEVICE, EMBOLIZATION, VASCULAR

Catalog Number UNKNOWN

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

Patient Problems Stroke/CVA (1770); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

The below description of a serious injury involving an unspecified tornado coil was taken from clinical study (b)(4).The cohort consists of patients who received one or more (b)(6) brand embolization devices during the period from 01 january 2014 to 31 december 2018.In summary, patients were included as part of the (b)(6) coil cohorts, respectively.Target population: used in patients who require a range of vascular interventions that include permanent vessel (arterial or venous) occlusion.Primary aims: to confirm the safety and performance of the device throughout its expected lifetime and to ensure continued acceptability of the benefit-risk ratio.Data collection type: retrospective collection of data from registries reporting on embolization outcomes or databases established within high-volume centers.The goal of the data collection is to evaluate data from consecutive patients who were treated with at least one of the specified embolization coils (the state of the art recognizes that patient treatment with combination therapies is common, so it is recognized that isolation of specific treatments is not reasonable).Specific objective: this post market clinical follow-up (pmcf) study is intended to address the safety and performance endpoints and assess whether the endpoints are within the acceptable range, as defined within the state of the art.The primary safety endpoint is defined as major adverse events occurring within 30 days of, and associated with, the embolization procedure.The primary performance endpoint focuses on technical success, defined as cessation or restriction of blood flow to the target area following coil deployment.The secondary performance endpoint, defined as clinical success, is assessed differently based on the condition being treated and the anatomic location and is generally defined in the sir quality improvement guidelines as measured results within 30 days of embolization.In addition to the endpoints, relevant long term (30 days) adverse events were summarized, reported, and used in the identification of any long-term safety signals.Rationale for the appropriateness of the specific methods and procedures: proactive pmcf activity is necessary in order to verify the continued safety and performance of these devices, and to confirm the continuation of an acceptable benefit-risk ratio.Data collected during pmcf efforts will ensure a robust clinical data set for all embolization devices, and an accurate assessment of the benefit-risk ratio in future evaluations.The data utilized in this pmcf study was sourced from existing data sources such as patient electronic medical records (emr) or registries, which are routinely utilized by healthcare institutions.This pmcf study utilized records at multiple institutions, and data was extracted that was relevant to the primary and secondary endpoints of the study.Potential clinics and institutions were evaluated based on their utilization of emr or patient registries, the volume of cook embolization coils used by the institution, and whether they use all coil types covered by this technical file.As observed in the previously assessed clinical literature, embolization devices are well established technologies that are intended for broad use in the venous and arterial anatomy, and the pmcf activity is intended to continue to support safety and performance in those broad uses.Results: the overall technical success for all coils was 96.7% (293/303) (95% confidence interval (ci): 94.0%, 98.4%).Therefore, the primary performance endpoint was successfully met and the technical success data supports the continued effectiveness of the embolization coils ((b)(6)).This data supports that the (b)(6) embolization coils continue to be safe and perform as intended.This report focuses on the following event reported in the study results: on post operative day 3, the patient experienced an embolic stroke (cerebrovascular accident cva).Additional related diagnosis codes were reported on the same day for ¿cerebral artery occlusion, unspecified, with cerebral infarction¿ and ¿cerebral thrombosis, with cerebral infarction.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Suspect medical device: (b)(6) embolization coil or (b)(6) microcoil.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Manufacturer Narrative

Suspect medical device: tornado embolization coil or tornado microcoil this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The below description of a serious injury involving an unspecified tornado coil was taken from clinical study (b)(6).The cohort consists of patients who received one or more nester, mreye, or tornado brand embolization devices during the period from 01 january 2014 to 31 december 2018.In summary, 110, 129, and 153 patients were included as part of the tornado, nester, and mreye coil cohorts, respectively.Target population: used in patients who require a range of vascular interventions that include permanent vessel (arterial or venous) occlusion.Primary aims: to confirm the safety and performance of the device throughout its expected lifetime and to ensure continued acceptability of the benefit-risk ratio.Data collection type: retrospective collection of data from registries reporting on embolization outcomes or databases established within high-volume centers.The goal of the data collection is to evaluate data from consecutive patients who were treated with at least one of the specified embolization coils (the state of the art recognizes that patient treatment with combination therapies is common, so it is recognized that isolation of specific treatments is not reasonable).Specific objective: this post market clinical follow-up (pmcf) study is intended to address the safety and performance endpoints and assess whether the endpoints are within the acceptable range, as defined within the state of the art.The primary safety endpoint is defined as major adverse events occurring within 30 days of, and associated with, the embolization procedure.The primary performance endpoint focuses on technical success, defined as cessation or restriction of blood flow to the target area following coil deployment.The secondary performance endpoint, defined as clinical success, is assessed differently based on the condition being treated and the anatomic location and is generally defined in the sir quality improvement guidelines as measured results within 30 days of embolization.In addition to the endpoints, relevant long term (> 30 days) adverse events were summarized, reported, and used in the identification of any long-term safety signals.Rationale for the appropriateness of the specific methods and procedures: proactive pmcf activity is necessary in order to verify the continued safety and performance of these devices, and to confirm the continuation of an acceptable benefit-risk ratio.Data collected during pmcf efforts will ensure a robust clinical data set for all embolization devices, and an accurate assessment of the benefit-risk ratio in future evaluations.The data utilized in this pmcf study was sourced from existing data sources such as patient electronic medical records (emr) or registries, which are routinely utilized by healthcare institutions.This pmcf study utilized records at multiple institutions, and data was extracted that was relevant to the primary and secondary endpoints of the study.Potential clinics and institutions were evaluated based on their utilization of emr or patient registries, the volume of cook embolization coils used by the institution, and whether they use all coil types covered by this technical file.As observed in the previously assessed clinical literature, embolization devices are well established technologies that are intended for broad use in the venous and arterial anatomy, and the pmcf activity is intended to continue to support safety and performance in those broad uses.Results: the overall technical success for all coils was 96.7% (293/303) (95% confidence interval (ci): 94.0%, 98.4%).Therefore, the primary performance endpoint was successfully met and the technical success data supports the continued effectiveness of the embolization coils (nester, tornado, mreye).This data supports that the nester, tornado, and mreye embolization coils continue to be safe and perform as intended.This report focuses on the following event reported in the study results: on post operative day 3, the patient experienced an embolic stroke (cerebrovascular accident- cva).Additional related diagnosis codes were reported on the same day for ¿cerebral artery occlusion, unspecified, with cerebral infarction¿ and ¿cerebral thrombosis, with cerebral infarction.".

Manufacturer Narrative

Investigation ¿ evaluation on (b)(6)2021, cook received a post market clinical follow-up (pmcf) containing treatment information for patients receiving implantable cook embolization coils.This data was provided by regenstrief institute and addresses patients treated in indiana healthcare facilities.This report focuses on a patient who received a tornado embolization coil or microcoil (rpn and lot # unknown) for unknown treatment.On postoperative day 3, the patient experienced an embolic stroke; post-encounter diagnosis code was reported to be cerebrovascular accident (cva), embolic.Additional diagnosis codes were reported on the same day for ¿cerebral artery occlusion, unspecified, with cerebral infarction¿ and ¿cerebral thrombosis, with cerebral infarction.¿ all of these diagnoses are considered to be related to the same event.No other adverse events were reported.Reviews of the complaint history, instructions for use (ifu), and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the possible product device master records (dmr) for both micro and macro coils and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.The customer did not provide the lot number for the complaint devices.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The current instructions for use [t_ce_tem_rev3] state the following: "instructions for use 1.Perform an angiogram prior to embolization to determine optimal catheter position.2.Push the loading cannula completely into the delivery catheter.3.Advance the luer lock connector fitting toward the catheter hub and lock into place.4.Use the pusher stylet to load the tornado embolization microcoil into the delivery catheter.Note: the stylet must be pushed as far as possible into the loading cannula to ensure proper loading.Remove the pusher stylet and loading cannula.5.To obtain secure placement of the tornado embolization microcoil, we recommend the use of the pusher stylet to push the microcoil further into the delivery catheter.6.Once coil is positioned into delivery catheter, verify position of catheter top prior to deployment.Coil design permits delivery into the target vessel by saline/contrast or by push technique using an appropriately sized wire guide or pusher.7.Perform final angiogram to confirm coil position within target vessel.How supplied upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no product returned, and the results of the investigation, cook has concluded that this was an adverse event related to procedure, and the cause cannot be traced to device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNKNOWN
• Type of Device: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12847658
• MDR Text Key: 286054007
• Report Number: 1820334-2021-02537
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability