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

Model Number SAB-4-20

Device Problem Separation Failure (2547)

Patient Problems Intracranial Hemorrhage (1891); Rupture (2208)

Event Date 01/03/2023

Event Type  Death  

Event Description

Medtronic received a report that the stent could not be detached.The patient was undergoing surgery for treatment of a fusiform, unruptured left side aneurysm with a max diameter of 4mm and a 5mm neck diameter.The landing zone was 4mm at the distal end and 3.8mm at the proximal end.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.The parent vessel was the internal carotid artery with 4mm diameter.The branch vessel was the anterior cerebral artery with 3mm diameter.It was reported that after operating according to the normal procedure, the stent could not be detached.Then, by checking the details of the detacher, positive and negative poles, insertion depth, etc.One by one, it still couldn't be detached.Finally, the patient's aneurysm ruptured and was immediately converted to open surgery for rescue.The reported device and any accessory devices were prepared as indicated in the ifu.New information was received.The patient had died.There are no procedural / post-procedural imaging (ct,angio, etc.) available.The physician did not feel any resistance while delivering the stent.The stent was deployed more than two times prior to detachment.The physician attempted to detach the stent with the detachment box three times.Which lasted more than 2 minutes for each attempt.The covidien detachment box was used.The condition of the detachment box was re-used.The condition of the detachment cable was re-used.The catheter tip was located 3 mm from the detachment zone during the detachment attempt.The needle was a 20g needle used during the detachment.The detachment box was displayed as indicated per ifu.The cable polarity was set up as indicated in the ifu.The needle was placed in the shoulder, then after not detaching, switch to thigh.The needle was in muscle.The black cable was connected to the needle.The red cable was connected to pusher wire.The pushwire was on a dry clean surface.The stent was not in a bend.The physician did use a new battery during the detachment.There were no visible damages on the detachment cable.

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

The event does not meet reportability criteria and is no longer reportable.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

The event does not meet reportability criteria and is no longer reportable.

• 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: 16158911
• MDR Text Key: 307301341
• Report Number: 2029214-2023-00061
• 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,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2024
• Device Model Number: SAB-4-20
• Device Catalogue Number: SAB-4-20
• Device Lot Number: B376749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Date Device Manufactured: 04/28/2022
• 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 Outcome(s): Life Threatening; Death
• Patient Age: 52 YR
• Patient Sex: Female