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

Model Number SFR4-4-40-10

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

Medtronic received a report that after deployment, when the stent was pulled back, a rupture occurred at the tip part of the shaft.The solitaire could not be collected so it was placed as it was.The patient's condition was the same as before the surgery.There was no vascular stenosis proximal to the thrombus formation site.The physician did not apply torque to the delivery pusher.There were 3 passes performed with the same stent.There was no resistance or difficulties during the procedure.The proximal marker of the stent was located within the microcatheter.The stent was placed in the middle cerebral artery.There was no surgical or medicinal intervention required.The surgeon did not attempt to dislodge the stent.The device was prepared as indicated in the package insert.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: the solitaire x pusher was returned for analysis.No bends or kinks were found with the solitaire x pusher.The pusher was found broken within the shrink tubing at ~189.2cm from the pusher proximal end (~38.0cm from proximal end of shrink tubing).When compared to the product drawing, ~11.0cm of the solitaire x pusher and the solitaire x stent were not returned.The solitaire x pusher was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the broken end failed via fatigue at the kink/bend area and the rest of the surface failed via overload.Based on the device analysis and reported information, the customer¿s ¿separation¿ report was confirmed.As the solitaire x pusher broke due to fatigue it is likely the pusher became bent subsequently breaking upon removal.However, it was reported there was no resistance or difficulties during the procedure.Therefore, the cause for the separation could not be determined.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

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 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: 14569257
• MDR Text Key: 293166295
• Report Number: 2029214-2022-00925
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B210993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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: 52 YR
• Patient Sex: Male