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

Model Number SFR-6-30

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2022

Event Type  malfunction  

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.

Event Description

Medtronic received a report that the solitaire experienced resistance and separated.The patient was undergoing treatment for an ischemic stroke located in the middle cerebral artery.The patient's baseline mrs, nihss, and tici scores were 0, 2, and 3 respectively.Post procedure these were 4, 2, and 3 respectively.Iv tpa was not contraindicated.The patient's vessel tortuosity was normal.The stroke onset to reperfusion time was 4 hours.It was reported that it was difficult for the solitaire stent to fully enter the microcatheter and the resistance was very large.Therefore, the surgeon withdrew the stent and found that the mesh in the invalid segment of the stent was ruptured.A replacement solitaire was able to be pushed smoothly and the surgery was successfully completed.No additional surgical or medical intervention was needed.There was not vessel stenosis proximal to the thrombus site, and the pushwire was not torqued during the procedure.The microcatheter tip did not cover the stent proximal marker during retrieval.No detachment attempts had been made. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a rebar 27 microcatheter.

Event Description

Additional information received reported that the resistance was large and in the proximal end.

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

Product analysis: as found condition: the solitaire fr revascularization device returned for analysis within a shipping box; and within a plastic bio- pouch.The rebar-27 micro catheter used in this event was not returned.The rebar-27 micro catheter has a labeled id (inner diameter) of 0.027¿.The solitaire fr stent device is compatible for use with a micro catheter with a minimum id of 0.021¿.Therefore, the rebar-27 micro catheter is compatible for use with the solitaire fr stent device.Visual inspection/damage location details: the solitaire fr stent was returned outside the introducer sheath.No defects were found with the marker coil or pushwire.Visual inspection showed no irregularities outside of the attachment zone area.The solitaire fr stent non-working (tear drop) strut was found to be broken.The working length strut was in good condition.No other anomalies were observed.Testing/analysis: the solitaire fr could not be used to test with an in-house micro catheter due to its damaged condition and separation.The broken end was sent out to element labs for sem (scanning electron microscopy) analysis.Per the sem result, the broken end failed via fatigue at the kink/bend area and the rest of the surface failed via over.Conclusion: based on the device analysis and reported information, the customer's report of ¿separation¿ was confirmed.However, the cause for the resistance could not be determined.A formal investigation has been conducted regarding solitaire separation issue.The review of lot history records shows that the finished device has met all manufacturing requirements and specification ns during final assembly and quality inspection.As per our instruction for use (ifu): ¿to prevent device separation: do not oversize device; do not recover (i.E.Pull back) the device when encountering excessive resistance.Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration.If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration; do not treat patients with known stenosis proximal to the thrombus site.There was no non-conformance to specifications identified that led to the reported issue.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 FR
• 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: 14978334
• MDR Text Key: 304517373
• Report Number: 2029214-2022-01142
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: SFR-6-30
• Device Catalogue Number: SFR-6-30
• Device Lot Number: B312681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG