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

Model Number SFR4-4-40-10

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

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

Medtronic received information that a sfr4 solitaire had resistance in the phenom21 and the solitaire delivery wire broke.The solitaire was selected for ais-m1 occlusion case.Guide catheter was delivered to the ic.Phenom21 was prepared according to the package insert and was regionally crossed to the distal portion of the thrombus occluded in m1 with a guidewire.The wire was removed.Solitaire was prepared according to the package insert and when an attempt was made to perform delivery, the delivery was extremely hard; the delivery wire broke when it was delivered even more vigorously.Because it could not be delivered to the tip of phenom 21, the solitaire was retrieved outside the body.Abnormalities were felt in solitaire but since there was a strong trust in the product, a new solitaire was opened and prepared as per the package insert; this solitaire was delivered smoothly to the inside of phenom21 without any problems; the procedure was completed safely.The products where abnormalities were felt were all retrieved outside the body, and there was no residue in the body.The resistance was felt in the proximal center section of the catheter.Tici postoperative was 3.The patient was being treated for a ischemic cerebral infarction in the m1p location.Vessel tortuosity was moderate.One pass was made with the solitaire device.The devices were prepared according to the package insert.No symptoms were reported.  ancillary devices: optimo9fr guide catheter, traxcess14 guidewire.

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

Analysis found that the pushwire did not break but was kinked.Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates a reportable event.

Manufacturer Narrative

H3.Product analysis: equipment used: vis (m-78210), ruler (m-83361), camera (panasonic lumix dmc-zs5).As found condition: the solitaire x stent device was returned for analysis within the introducer sheath; within the outer carton; inside of a biohazard bag and a shipping box.There was no phenom 21 catheter returned with the stent.However, the phenom 21 catheter appeared to be compatible for use with the solitaire x stent as it has a labeled inner diameter (id) of 0.021".Visual inspection/damage location details: the finger markers were examined inside the introducer sheath and they were aligned properly.The solitaire x stent working and non-working lengths were found in good condition.Visual inspection showed no irregularities outside of the proximal marker.No damage was observed on the marker coil.The pushwire was found intact.However, the pushwire was observed to be bent at 11.5cm to 17.0cm from the distal finger marker.No other anomalies were observed.Testing/analysis: the solitaire x was removed from the introducer sheath with difficulty due the damaged pushwire.The returned solitaire x stent device could not be used for resistance testing due to its damaged conditions.Conclusion: based on the reported information and the device analysis, the customer¿s complaint "pushwire separation" was not confirmed as the pushwire was found intact.No separation was observed on the pushwire.However, the solitaire x stent was confirmed to have "stent resistance during delivery" issue as bends were observed on the pushwire.No damage was found with the stent.The cause for resistance and damages could not be determined.It is possible the damages occurred when the customer attempted to deliver the solitaire x stent device through the catheter against resistance.Possible causes include the use damaged catheter, vessel tortuosity and lack of continuous flush with heparinized saline during delivery.There was no non-conformance to specifications identified that led to reported issue.Since the catheter was not returned; any contribution of the catheter to the resistance issue could not be determined.H6.Coding updated based on analysis results.Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates a reportable event.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: 14332603
• MDR Text Key: 299850544
• Report Number: 2029214-2022-00801
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113455
• 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: 08/15/2022

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 Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B328183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/08/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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