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

Model Number SFR-6-30

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

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

Medtronic received information a stent had resistance in the rebar18 and the stent wire was broken.The patient was being treated for an ischemic stroke in the end of the internal carotid artery. mrs: baseline 6 mrs: procedure 5 nihss score: baseline 15 nihss score: post procedure 15 tici score: baseline 0 tici score: post procedure 2b.Iv tpa was not contraindicated.1 pass was made with the device.Vessel tortuosity was normal.The devices were prepared as indicated in the instructions for use (ifu).When the stent entered the microcatheter, the resistance was obvious.After pulled it out, it was found that the welding point of the stent was broken, and the stent wire was separated from the welding point.The resistance occurred during the delivery procedure.The resistance was at the catheter hub.The rotating hemostatic valve  was not loose during delivery.The sheath was secured in the hub of the microcatheter.There was no vessel stenosis proximal to the thrombus site.The pushwire was torqued during the procedure.1 pass was made using the stent.There was friction or difficulty during the procedure.The microcatheter tip covered the stent proximal marker during retrieval.The stent was removed from the patient.The physician did not attempt to detach the stent.No surgical intervention was required.

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 reported that a rebar 18 catheter was used.

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

H3: as found condition (condition of returned device): the solitaire fr revascularization device was returned for analysis within a shipping box and within a sealed biohazard pouch.The rebar-18 catheter used during the event was not returned for analysis.Visual inspection/damage location details: as per the solitaire fr stent ifu (instructions for use) the 6-30 stent must be used with a micro catheter with a minimum id (inner diameter) of 0.027in.Per the rebar-18 catheter product labeling, the id is 0.021¿.Therefore, the solitaire fr stent was found to be not compatible for use with the rebar catheter.The solitaire fr revascularization device was returned without its introducer sheath.No bends or kinks were found to be the pushwire.The marker coil was found to be in good condition.Visual inspection of the detachment zone revealed no electrical etching.The detachment zone was found to be damaged.The stent was found to be still attached to the pushwire.The stent non-working (tear drop) length struts were found to be damaged (bent) but not broken at proximal end.The middle and working length struts were in good condition.The finger markers were found to be intact.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿resistance during retrieval¿ could not be confirmed and the root cause could not be determined.Resistance can be caused by lack of continuous flush.It is also likely the resistance was caused by incompatible catheter.Based on the device analysis and reported information, the customer¿s report of ¿kink/damaged¿ was confirmed as the non-working length struts were found to be damaged.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 FR
• 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: 13815761
• MDR Text Key: 297428605
• Report Number: 2029214-2022-00439
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 07/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: SFR-6-30
• Device Catalogue Number: SFR-6-30
• Device Lot Number: B255585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2021
• 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: 65 YR
• Patient Sex: Male