MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number 105-5081-153

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Stenosis (2263); Thromboembolism (2654)

Event Date 11/22/2022

Event Type  Injury  

Event Description

Medtronic received information that a solitaire fr stent had resistance in a rebar 18 catheter and broke.When another solitaire was used there were complications.Guided by the micro-guide wire with a micro-catheter (rebar 18), using coaxial technology, guided the intermediate catheter to the lower end of the basilar artery, passed the micro-guide wire and micro-catheter through the occlusion segment, withdrew the micro-guide wire.Microcatheter microangiography showed that the distal vascular bed was well developed, intermediate catheter angiography showed that the thrombus load capacity.Then the solitaire fr 6mm"30mm stent was slowly pushed through the microcatheter.During the pushing process, the stent was difficult to push, and the push was dry.After pushing the stent into the microcatheter for 15cm, it was still difficult to push the stent, and then retracted the stent.During the retraction process, the stent broke.The distal end of the stent remained in the microcatheter, and the microcatheter was withdrawn (rebar 18).Under the guidance of the micro-guide wire with microcatheter (rebar 27), passed the micro-guide wire and the micro-catheter through the occluded segment of the basilar artery, withdrew the micro-guide wire.The solitaire fr6mm*30mm stent was replaced, and then the solitaire fr 6mm*30mm stent was slowly pushed and deployed through the microcatheter to cover the thrombus.The microcatheter was withdrawn, and the angiography showed that the blood vessel was partially recanalized.After the stent self-expanded for 5 minutes, the stent was recovered and continuously sucked through the intermediate catheter, and a large number of thrombus was seen.The dark red thrombus attached to the stent was seen; the guide catheter angiography showed recanalization of the basilar artery, the distal blood flow mtic1 was grade 2b, the lower end of the basilar artery was severely narrowed, and theblood flow was difficult to maintain.Delivered the micro guide wire to the left posterior cerebral artery, delivered the intracranial balloon (2.75*20) to the stenosis alo ng the micro guide wire, after the alignment was accurate, filled the balloon with 6atm pressure, withdrew the balloon, and delivered the system , re-examination angiography, stenosis improved than before.The stent was delivered to the stenosis along the micro-gu ide wire, deployed after the alignment was accurate, the stent delivery system was withdrawn, reexamined the angiography, and the stenosis was significantly improved, and the stenosis rate was less than 20%.The forward blood flow improved, the intermediate catheter was withdrawn, and the guiding catheter angiography showed bilateral posterior cerebral arteries and bilateral superior cerebellar arteries in the brain, which were well developed.Withdrew the guiding catheter and ended the operation.The resistance was in the distal section of the catheter.It broke at the detachment point.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an ischemic stroke in the basilar artery.Mrs: baseline 0.Mrs: procedure 4.Nihss score: baseline 30.Nihss score: post procedure 30.Tici score: baseline 0.Tici score: post procedure (level 3).Iv tpa was not contraindicated.One pass was made with the device.Vessel tortuosity was severe.Ancillary devices: 5f navien 125 distal access catheter, avigo guidewire, intracranial dilatation balloon.

Manufacturer Narrative

Event related to regulatory reports: 2029214-2022-02005, 2029214-2022-02006.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.

Manufacturer Narrative

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.

Event Description

New information was received.The patient's weight at the time of the reported event was 65 kg.The patient improved slightly after the surgery, and could move the lower limbs according to the instructions, and the muscle strength of the upper limbs was paralyzed at level 2.The patient experienced related symptoms, this time was acute onset related to the stenosis.The relationship between stenosis and thrombus couldn't be determined.It was considered as post-stenosis thrombosis.Solitare lot #'s: lot number that had resistance and broke: b315735, second fr lot number: b316305.The rebar lot#'s: rebar18 lot number:b230926;rebar27 lot number:b344536.

Manufacturer Narrative

Product analysis: as found condition: the solitaire fr stent device and rebar-18 microcatheter were returned for analysis within a shipping box; within a sealed plastic bio-pouch, and within an opened solitaire fr outer carton.The solitaire fr stent device was returned within the rebar-18 microcatheter.Damage location details: the solitaire fr pusher was found extending out from within the rebar 18 microcatheter hub for ~0.5cm.No damages were found with the rebar-18 microcatheter hub.The rebar-18 catheter body was found damaged (kinked) at ~ 27.7cm from the catheter distal end.The solitaire fr stent pusher was found to be broken at ~38.7cm from the pusher distal end.The solitaire fr pusher marker coil was found bent.The stent was found to be still attached to the pusher.The stent's teardrop and non-working length struts were found bent.The stent¿s working length struts were in good condition.Testing: the solitaire fr stent device was pulled out from within the rebar-18 microcatheter.The rebar-18 micro catheter was flushed, water exited from the distal tip.An in-house 0.021¿ mandrel inserted through rebar 18 catheter with resistance at the catheter kink.The solitaire fr pusher was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the wire failed via ductile overload.Conclusion: based on the device analysis and the reported information, the customer¿s reports of ¿resistance during delivery/retrieval¿, ¿separation¿ and ¿catheter resistance¿ were confirmed.Resistance was encountered during testing and the solitaire fr pusher was found broken.In this event, the cause of the separation was likely due to the user advancing/retrieving the device against resistance.Possible causes of resistance during delivery are user does not maintain a continuous flush, patient¿s vessel tortuosity, use of an incompatible catheter, or catheter damage.Information regarding a continuous flush was not provided; therefore, ¿user does not maintain continuous flush¿ could not be ruled out as a potential cause.The rebar 18 microcatheter has a labeled id (inner diameter) of 0.021¿.As per the solitaire fr ifu (instructions for use), the solitaire fr stent device is compatible for use with microcatheters with a minimum id of 0.027¿.Therefore, the rebar 18 microcatheter was found not compatible for use with the solitaire fr stent device.In this event, it is likely the patient¿s ¿severe¿ vessel tortuosity, the damage to the rebar-18 microcatheter (kinking), and the use of an incompatible catheter contributed to the reported resistance.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.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15872859
• MDR Text Key: 304417696
• Report Number: 2029214-2022-02007
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: 00847536026834
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: B230926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male