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

Model Number SFR4-3-20-10

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

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the thrombus was collected using the solitaire.When an attempt was made to check the thrombus attached to the stent, a thread-like substance was attached and it was believed that the solitaire was broken.There was no effect on the patient.It was noted that there was resistance during the procedure, and it was the tip of the stent that was damaged. the event was said to be not associated with the patient. the devices were prepared according to the instructions for use (ifu).Ancillary devices include a sofia 5fr catheter.

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

Additional information received clarified that the thread-like piece was not separated from the rest of the stent.The resistance was in the middle part of the catheter, and the patient's vessel tortuosity was moderate.

Manufacturer Narrative

H3: the solitaire x working length was found in good condition.The non-working length was found to be kinked at the tear-drop struts.Visual inspection showed no irregularities outside of the proximal marker.The marker coil was found damaged.No bend was found on the pushwire.The solitaire x was found intact.No separation or "threat-like substance" was observed on the returned stent.The sofia 5f tip and marker band were examined; no damages were found.The catheter body was found flattened at 3.0cm to 15.0cm from the distal tip.In addition, the catheter body also found kinked at 13.0cm and 31.5cm from hub.No other anomalies were observed.The catheter was flushed with water and found to be patent.The returned solitaire x and sofia 5f catheter could not be used for resistance testing due to the damaged conditions.Based on the reported information and the device analysis, the customer complaint of "resistance during delivery/retrieval" was confirmed as the returned solitaire stent was found to be damaged at the tear-drop struts.The marker coil was damaged.In addition, the sofia 5f catheter was flattened and kinked at several locations.It is possible the damage occurred when the customer attempted to deliver/retrieve the solitaire x device through the catheter against resistance.However, the root cause and the cause for damages could not be determined.Possible causes include but are not limited to the use damaged catheter, vessel tortuosity and lack of continuous flush with heparinized saline during delivery.Regarding to the "separation" issue, the customer complaint was not confirmed as the returned solitaire x was found intact.No separation or "threat-like substance" was observed on the returned stent.There was no non-conformance to specifications identified that led to reported issues.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

H3: the solitaire x and sofia 5f catheter were returned for analysis.The sofia 5f catheter appeared to be compatible for use with the solitaire x as it has a labeled inner diameter (id) of 0.055".The solitaire x working length was found in good condition.The non-working length was found to be kinked at the tear-drop struts.Visual inspection showed no irregularities outside of the proximal marker.The marker coil was found damaged.No bend was found on the pushwire.The solitaire x was found intact.No separation or "thread-like substance" was observed on the returned stent.The sofia 5f tip and marker band were examined; no damages were found.The catheter body was found flattened at 3.0cm to 15.0cm from the distal tip.In addition, the catheter body also found kinked at 13.0cm and 31.5cm from hub.No other anomalies were observed.The catheter was flushed with water and found to be patent.The returned solitaire x and sofia 5f catheter could not be used for resistance testing due to the damaged conditions.Based on the reported information and the device analysis, the customer complaint of "resistance during delivery/retrieval" was confirmed as the returned solitaire stent was found to be damaged at the tear-drop struts.The marker coil was damaged.In addition, the sofia 5f catheter was flattened and kinked at several locations.It is possible the damage occurred when the customer attempted to deliver/retrieve the solitaire x device through the catheter against resistance.However, the root cause and the cause for damages could not be determined.Possible causes include the use damaged catheter, vessel tortuosity and lack of continuous flush with heparinized saline during delivery.Regarding to the "separation" issue, the customer complaint was not confirmed as the returned solitaire x was found intact.No separation was found on the stent.Based on the photo in japan-tac, a thread-like substance with dried blood was observed on the distal end of the stent.However, no "thread-like" substance with dried blood was observed on the distal end of the returned stent.There was no non-conformance to specifications identified that led to reported issues.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 X
• 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: 14307327
• MDR Text Key: 299691407
• Report Number: 2029214-2022-00786
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2024
• Device Model Number: SFR4-3-20-10
• Device Catalogue Number: SFR4-3-20-10
• Device Lot Number: B214795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 05/10/2022; 06/15/2022
• Supplement Dates FDA Received: 06/01/2022; 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1