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

Model Number	SFR4-6-40-10
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Medtronic received information that a solitaire device had difficulty recapturing during a thrombectomy.The physician felt resistance when the sfr entered the microcatheter.Upon inspection, it appears to be a partial (to near complete) fracture of the device from the wire.Everything was removed from patient and still in the microcatheter.The pushwire broke/separated.The pushwire was not torqued during the procedure.Resistance was encountered.All broken segments of the pushwire were removed as all were in the microcatheter when it was removed.The devices were prepared as indicated in the instructions for use (ifu).The patient was treated for an ischemic stroke in the m1 location.2 passes were made with the device.No patient symptoms or complications were reported.
Additional Manufacturer Narrative
Product analysis: as found condition: the solitaire x revascularization device was returned for analysis within a shipping box and within an opened solitaire x outer carton (b299400).Visual inspection/damage location details: no bends or kinks were found with the solitaire x marker coil.The stent attachment zone was found in good condition.The solitaire x stent non-working length struts were found knotted.The remaining solitaire x stent was found in good condition.No breaks or separations were found with the solitaire x revascularization device.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s ¿pushwire break/separation¿ report could not be confirmed.No breaks or separations were found with the solitaire x revascularization device.Regarding the customer¿s ¿resistance during retrieval¿ report, the issue was confirmed.It is likely the damage found with the returned solitaire x stent (knotting) contributed to the reported resistance.Based on the device analysis and reported information, the customer¿s report was confirmed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary (see tr-nv13887 - solitaire knotting).Based on the investigation conducted, it is unlikely that the knot formation occurred during manufacturing or missed inspection as there are multiple processing steps and/or in-process controls throughout the production processes.The potential for forming a knot exists related to the standard interventional procedures where the physician/technician loops around the device for placement in the fluid filled basin on the sterile table or to minimize contamination and potential device drop on the floor.In conclusion, the knot does not occur due to failure of the product to meet its specification as designed.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 or Problem Description
Additional information received reported there was no definite cause given.

• Brand Name: SOLITAIRE FR4
• Common Device Name: 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: 15059898
• Report Number: 2029214-2022-01196
• Device Sequence Number: 5455088
• Product Code: NRY
• UDI-Device Identifier: 00763000425739
• UDI-Public: 00763000425739
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2024
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B299400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown