MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-325-20 |
Device Problems
Retraction Problem (1536); Material Deformation (2976); Unintended Movement (3026); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The react-71 catheter was returned for analysis within a shipping box; within a tyvek bio-pouch; within a plastic bio-pouch and within a re-sealable plastic bio-pouch.The react-71 catheter total length was measured to be 145.0cm and the useable length was measured to be 138.0cm which is not within specification (specification: 132cm +3/-0cm).No damages or irregularities were found with the react-71 hub.No bends or kinks were found with the react-71 catheter body.However, the react-71 catheter body was found stretched from 33.5cm to 29.0cm from the distal end.Upon microscopic inspection, the catheter inner wire was found intact.The react-71 distal marker/tip was found separated from the catheter.The tubing material of the separated end exhibited with stretching, necking and jagged edges with the inner braid exposed.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter accordion¿ was confirmed.The react-71 catheter body was found stretched and the distal marker/tip was found separated from the catheter.The react-71 catheter appears to have been stretched for -8cm.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.Possible causes for the event could be attributed to tortuous anatomy and/or other contributing factors such as kink/damage in guide catheter / balloon guide catheter /guidewire/stents which can cause the react-71 catheter to become damaged.It is unlikely for the distal shaft to become separated without experiencing excessive resistance.In addition, hard clots /calcifications in the navigation tract can snag the catheter causing damage, resistance, and subsequent separation.However, there is insufficient information to determine the cause of the damages found with the returned react-71 catheter.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 pipeline flow diverting stent (ped2-325-20, lot a822938) was deployed without any problem.However, when capturing the delivery wire, the tip coil did not enter inside the microcatheter, and the stent dropped when the system was removed: the distal part of the stent stayed on the aneurysm neck.There was no friction, the pipeline did not miss the landing zone or jump, the stent was placed at least 3 mm on each side of the aneurysm neck, and the ophthalmic artery side branch was covered.As a result, a second pipeline stent (ped2-350-16, lot a859164) had to be deployed in the distal zone of the artery, telescoping the first one.The second pipeline was deployed without any issue, using the same marksman microcatheter.When observing the delivery wires, it was noticed that the ptfe sleeves of the first stent are apparently deformed and it could have prevented the tip coil to enter inside the microcatheter.When comparing both delivery wires, we can see that the distal tip coil of the second stent is more smooth.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results were ok.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery with a max d iameter of 5 mm and a 3.5 mm neck diameter.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was administered.Ancillary devices include a fargo max 070 guidecatheter, marksman microcatheter, avigo guidewire.
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Event Description
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No additional information received.
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Manufacturer Narrative
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H6: device code a010402 does not apply to the event and has been corrected to a0512.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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