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

Model Number SFR4-4-40-10

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Medtronic received information that a solitaire sfr4 stent had resistance in the distal section of the catheter ad disconnected.There was considerable resistance from the first time of thrombus collection.The stent had resistance, but the entire blood vessel was calcified and the ic's arteriosclerosis was strong.Somewhat the resistance was convincing.Resistance was felt in the second pass, but it seemed to be slightly open.When the 3rd pass was performed, the stent was cut off, leaving the stent in the ic to m1, resulting in m1 blockage.In the 3rd pass, the react was removed and was pulled only with the stent.The microcatheter was not covered by the stent's proxy marker when the stent was being pulled.The resistance was at the time of collection.The blood vessel had strong tortuosity.There vascular stenosis proximal to the thrombus formation site.3 passes were preformed with the same stent.The proximal marker of the stent was not located within the microcatheter when the stent was collected.The stent is within the patient's body in the ic top to m1.No surgical or medical intervention is required.The surgeon did not attempt to dislodge the stent.The patient was being treated for an ischemic cerebral infarction in the m2 location. nihss (pre-operative) 21.Nihss (postoperative) 21.The patient had health damage.  ancillary devices: optimo 9f guiding catheter, track21 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.

Event Description

Additional information received reported that delivery was cut off at the 3rd pass, but the 2nd and 3rd passes were torqued when the solitaire stopped moving.The solitaire itself did not rotate.The 1st and 2nd passes covered, but the 3rd pass did not cover.The vessel was not revascularized after the solitaire was removed, and the m1 is still blocked.

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.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

Product analysis: as found condition: the solitaire x revascularization device pusher was returned for analysis within a shipping box and within two resealable plastic biohazard pouches.The stryker trak-21 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the solitaire x proximal pusher.The distal marker coil was found stretched.The solitaire x stent was found separated from the pusher under the marker coil.The stent was not returned for analysis and reported remaining within the patient.Testing/analysis: the broken end was sent out for sem analysis.Sem results: ¿the wire failed via overload¿.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿separation¿ was confirmed.It is likely the failure occurred due to retraction against the reported high resistance.Other potential causes are patient stenosis, vessel tortuosity, pre-existing stents, user makes more than 2 passes, or a new microcatheter was not used with each solitaire.Customer reported blood vessel was calcified, 3 passes were performed, vessel had ¿strong tortuosity¿, and solitaire was not rotated.Possible causes of resistance are damaged catheter, patient vessel tortuosity, user uses same micro catheter with multiple solitaire devices, damage to stent/pushwire, user does not maintain continuous flush, user does not maintain correct flush rate, rhv loose during delivery or introducer sheath damage.As the stent and the microcatheter used in the event were not returned for analysis, any contribution of the stent and the micro catheter towards the resistance and the separation could not be determined.The trak-21 micro catheter has an inner diameter of 0.021¿ which is compatible for use with the solitaire x device.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.

• 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: 15238186
• MDR Text Key: 298025911
• Report Number: 2029214-2022-01387
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2024
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B187771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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 Age: 75 YR
• Patient Sex: Female