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Model Number REACT-71 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problems
Cardiac Arrest (1762); Death (1802); Stenosis (2263); Insufficient Information (4580)
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Event Date 10/02/2020 |
Event Type
Death
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received a report that the physician felt significant resistance while removing the react, velocity, and infinity.It was noticed after moving the react, there was a distal ring remaining in the anatomy.Right vert 6-7 mm into right vert two hairpin turns.In the middle of the turns, there was a significant restriction/stenosis in the origin of thevert.An attempt was made to retrieve with a 4 mm gooseneck snare.The patient went into cardiac arrest and died shortly after.The physician stated they did not believe the patient's death was related to the mechanical thrombectomy.The patient had a history of high blood pressure and a-fib.The patient was undergoing surgery for stroke due to thrombus.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received reporting that the distal ring was believed to be in reference to the marker band from the react catheter.The gooseneck snare successfully retrieved the loose device part.The patient's cause of death was noted to be "cardiac arrest.".
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Manufacturer Narrative
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The (penumbra) velocity catheter was not returned.The velocity catheter has a proximal od (outer diameter) of 2.95f (0.039¿), and a distal od of 2.6f (0.034¿).The react 71 catheter has a labeled id (inner diameter) of 0.071¿.Therefore, it appears the velocity catheter is compatible for use with the react 71 catheter.The react 71 catheter total length was measured to be ~143.0cm (reference: 141cm +/-3cm) and the useable length was measured to be ~135.0cm which is within specifications (specification: 132cm +3/-0cm).Upon visual inspection, no damages or irregularities were found with the react 71 hub.The catheter body appeared to be stretched at ~20.0cm to 32.0cm from the distal tip.The catheter body also found to be kinked at ~63.8cm from the catheter hub.In addition, the react 71 distal marker band/tip was found to be separated.The tubing material of the react 71 catheter separated end exhibited with stretching and jagged edges with the inner wire stretched and exposed.Due to its damaged condition, the react 71 catheter could not be used for resistance testing.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed as the returned react 71 catheter was found kinked and stretched.Additionally, the react 71 distal marker band/tip was found to be separated.The broken end of the catheter exhibited with plastic deformation (jagged edges and stretching) which indicated that the catheter separated when exceeding the tensile strength of the tubing material.It is likely that these damages occurred when the customer attempted to remove the velocity catheter from the react 71 catheter against the resistance.However, the root cause for the resistance could not be determined.Since the velocity catheter was not returned; any contribution of the velocity catheter to the resistance could not be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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