MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number SFR4-4-40-10

Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/07/2022

Event Type  malfunction  

Event Description

Medtronic received information that a solitaire sfr4 stent pushwire broke.The stent unintentionally detached.The sfr4 tracked through system and deployed at m1ca.Traction applied and sfr4 pulled back to terminal internal carotid artery (ica) where it became stuck.Operator believed that the ica may have been heavily calcified - preventing recapture of the sfr4 via the phenom 21.Operator states applied considerable traction to the sfr4 and system yet it would not move.Operator states that usually resolution of this kind of complication can be found by recapturing the phenom 21 microcatheter with a long intermediate catheter.However, 115cm axs was not long enough to achieve this.Operator states that detachment of the sfr4 from the push wire was the best outcome in the situation.The pushwire separation occurred in the distal portion proximal to the stent.Unsure how much of the pushwire remains in the patient.Resistance occurred.All broken segments of the pushwire was removed from the patient.The stent remains in patient.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an ischemic stroke.She was being treated for a ica m1ca occlusion.No patient symptoms were reported.Operator states no iatrogenic event.  ancillary devices: axs cat 5 115cm intermediate catheter, phenom 21 160cm microcatheter.

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.

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.

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

Additional information received reported mca occlusion no visible calification, some ica califcation.Vessel tortuosity was moderate.The patient¿s baseline was nihss 0.The patient¿s post-thrombectomy condition was nihss 3, tici3.The resistance was in the distal part of catheter, but this was not an issue as the stent was deployed normally.One pass was made prior to separation.The stent co uld not be retrieved.Tried to resheath with phenom 21 but it was not successful.No torquing was attempted.Some califcations in the ica supra clinoid was noted.The microcatheter tip did not cover the solitaire device proximal marker during the attempted retrieval.The anatomical location of the solitaire was in the supra clinoid ica left side.

Manufacturer Narrative

Product analysis: ¿as found condition: the solitaire x was returned for analysis within a shipping box; and within a plastic bio-pouch.¿visual inspection/damage location details: no damages or irregularities were found with the solitaire x marker coil.The solitaire x pushwire was found broken at distal from marker coil.The stent will not be returned as it remains within the patient.No other anomalies were observed.¿testing/analysis: the pushwire broken end will be sent out for sem (scanning electron microscopy) analysis.¿conclusion: based on the device analysis and reported information, the customer¿s report of ¿separation¿ and ¿resistance¿ were confirmed.Per the sem analysis report, the wire failed via overload.A formal investigation has been conducted regarding this issue.Product labeling was reviewed and provides several contraindications, complications, warnings, and instructions for the use and handling of the device in order to prevent damage and separation.Based on the formal investigation conducted, device separation can occur due to anatomical considerations such as level of tortuosity or variants of anatomy at the aortic arch or neurovasculature, delivery and retrieval friction, resistance where the forces applied to the binding of the solitaire device may be greater, higher number of device passes, guide catheter technique, guide / balloon catheters or intermediate catheter integrity issues such as kinking within the shaft, presence of a pre-existing extra/intracranial stenosis or calcified plaque, presence of hard clots / thrombus entanglement with over bending during the retraction process, alignment of the microcatheter with the proximal end of the solitaire device, removal of the microcatheter prior to retrieval of the solitaire device with or without clot.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: SOLITAIRE FR4
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: 15230148
• MDR Text Key: 303741394
• Report Number: 2029214-2022-01371
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113455
• 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,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B393173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 84 YR
• Patient Sex: Female