MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number SAB-6-30

Device Problem Material Deformation (2976)

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

Event Date 04/10/2024

Event Type  malfunction  

Event Description

Medtronic received information that a solitaire stent was damaged during preparation.The healthcare provider (hcp) performed a thrombectomy for a base artery occlusion.He planned to remove the thrombus with a stent.After establishing access to the diseased blood vessel, the assistant prepared to apply the stent for the next step of the surgery.During the process of hydrating and flushing the stent, it was found that the water at the end of the sheath was not returning well.The assistant checked the situation, pushed out the stent, and found that the stent was kinked near the detachment point.For the safety of the operation, the surgeon replaced the stent with the same model of stent and recanalized it once, successfully completing the operation.The stent was suspected to be kinked near the proximal detachment point.The surgeon was worried about breakage and replaced the stent with the same model.The devices were prepared according to the instructions for use (ifu).The patient was being treated for an ischemic stroke in th basilar artery  mrs: baseline 4, mrs: procedure 4, nihss score: baseline 16, nihss score: post procedure 4, tici score: baseline 0, tici score: post procedure 3.Vessel tortuosity was normal.No patient symptoms or complications were reported.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received reporting the stent was not kinked before handling, and when flushing, followed the routine operation.The surgeon thought the cause might be the stent itself.

• Brand Name: SOLITAIRE AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• 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: 19093917
• MDR Text Key: 340696769
• Report Number: 2029214-2024-00645
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAB-6-30
• Device Catalogue Number: SAB-6-30
• Device Lot Number: B519393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Date Device Manufactured: 02/15/2023
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG