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

Model Number	SFR3-6-40-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The solitaire has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the solitaire platinum separated and remained in the patient.Prior to the event, there were two aspiration only attempts.After the aspiration attempts, the solitaire was deployed in the right middle cerebral artery (mca) and opened for five minutes.Upon pulling the stent out of the cavernous internal carotid artery (ica) after one pass, the reported event occurred.A stent was deployed inside the solitaire stent as intervention.The patient was undergoing mechanical thrombectomy for treatment of an ischemic stroke located in the right middle cerebral artery (mca).The patient¿s mrs, nihss, and tici scores were unknown.The patient¿s vasculature was moderate in tortuosity.
Additional Manufacturer Narrative
D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the device was returned for evaluation and the clinical observation was confirmed.As received, only solitaire platinum pushwire was returned for analysis.Solitaire platinum stent was not returned as it was remained in the patient.No bends or kinks were found with the pushwire or marker coil.The pushwire appeared to be broken from the distal marker coil.The broken end was sent out for sem (scanning electron microscopy) analysis.No other anomalies were observed.Per the sem (scanning electron microscopy) analysis report, the broken end exhibit similar dimple features indicative of tensile overload failure mechanism.This indicates that the pushwire separated as the tensile strength of the pushwire was exceeded.It is likely the pushwire broke as a result of high force used (pulling).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.¿ 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 PLATINUM REVASCULARIZATION DEVICE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9386841
• Report Number: 2029214-2019-01178
• Device Sequence Number: 16705104
• Product Code: NRY
• UDI-Device Identifier: 00847536034792
• UDI-Public: 00847536034792
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: SFR3-6-40-10
• Device Lot Number: A872474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention