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 04/09/2022

Event Type  malfunction  

Event Description

Medtronic received information that a solitaire had resistance in the catheter when being retracted and the solitaire broke.The devices were prepared as indicated in the instructions for use (ifu). solitaire broke off inside cat 6 aspiration catheter when being retracted post thrombectomy.The resistance was in the distal section of the catheter.No symptoms were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: ¿ as found condition: the solitaire x revascularization device and catalyst 6 (cat-6) catheter were returned for analysis within a shipping box and within four various biohazard pouches.¿ visual inspection/damage location details: no damages or irregularities were found with the cat-6 hub.The distal catheter was cut into 5 segments.The distal catheter was found accordioned.No bends or kinks were found with the solitaire x pusher.The marker coil was found stretched.The solitaire x stent was found to have detached from the pusher at the attachment zone.No evidence of electrical etching was found on the detach wire.The stent was found extending out of one of the cat-6 catheter segments.The stent was extracted out of the segment against resistance.Two solitaire x stent non-working (teardrop) length struts were found separated.The distal stent and finger markers were found cut from the remaining stent and found within a different catheter segment.¿ testing/analysis: the separated stent and distal wire was sent out for sem analysis.The stent could not be used for resistance testing as the catheter and stent were returned damaged.¿ conclusion: based on the device analysis and reported information, the customer report of ¿resistance during delivery/retrieval¿ was confirmed as the damages found (accordioned catheter, marker coil stretch, stent separation) is consistent with resistance.Possible causes are incompatible catheter, damaged catheter, patient vessel tortuosity, user does not maintain continuous flush, user uses same catheter for multiple solitaire devices, rhv loose during delivery, or introducer sheath damaged.The customer¿s report of ¿separation¿ was confirmed.Per sem report: ¿the distal wire failed via ductile overload¿.It is likely the separation occurred due to retracting the device against the reported resistance.The non-working length struts were reported per sem to be cut: ¿strut failed via mechanical cutting¿.It is likely the stent struts were cut during the attempts by the physician to remove the stent from the catheter when the catheter was cut.The cat-6 catheter has an inner diameter of 0.060¿, which is not compatible for use with the soli taire x (compatible for micro catheter with an inner diameter of 0.021¿-0.027¿).It is likely the resistance and subsequent separate occurred due to the incompatible devices.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.

Event Description

Additional information received reported that the lesion characteristics (location, size, type, side, dimension, etc.) m1 occlusion.Vessel tortuosity was moderate.The device broke inside cat6 aspiration catheter.Both devices were able to be removed together along with the clot.The procedure was successful and no additional action was needed to treat the patient.The was no adverse outcome.

• 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: 14168940
• MDR Text Key: 291952108
• Report Number: 2029214-2022-00686
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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