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

Model Number SFR4-6-40-10

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/04/2023

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.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

Medtronic received a report that the doctor introduced the red 68 aspiration catheter, then inside it he introduced the phenom 21 microcatheter and inside it the solitaire 6x40 stent.In the first step, the doctor noticed that the solitaire was very tight inside the phenom 21 but he still managed to raise the device and remove it intact.The doctor tried again to passed the solitaire in which he indicated that it felt softer to the step compared to the first step, he deployed the solitaire and waited the indicated time to remove it.When trying to remove the solitaire, the doctor noticed that it was softer than normal and that the device did not retract when he realized that it had become loose from the push wire, leaving the solitaire inside the patient.The doctor used a second solitaire stent to recover the first solitaire from the patient.The resistance occurred at the hub of the phenom 21 microcatheter.The rotating hemostatic valve (rhv) was not loose during deliver and the sheath was secured in the hub of the phenom 21.The pushwire was not torqued during the procedure.The pushwire broke in the distal segment and all parts of the pushwire were removed from the patient using another solitaire stent.The solitaire and any accessories were prepared as indicated in the instructions for use (i fu).  the patient was undergoing surgery for treatment of an ischemic stroke at the m2 region.Two passes were made with the solitaire stent.It was noted that the patient's vessel tortuosity was moderate.The stroke onset to reperfusion time was 30 minutes.  ancillary devices include a red 68 aspiration catheter.

• 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: 18116054
• MDR Text Key: 328042225
• Report Number: 2029214-2023-02190
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K183022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2023

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
• Device Operator: Health Professional
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B577559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/10/2023
• Date Device Manufactured: 06/23/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 62 KG