MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number SAB-6-30

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

Medtronic received a report that the solitaire stent was accidentally detached in react71.The patient was undergoing surgery for treatment of an ischemic stroke of the right middle cerebral artery.The patient's mrs baseline was 6 and procedure was 4.The nihss score was 42 and tici 2 at baseline.The nihss was 20 and tici 3 post procedure.Iv tpa was not contraindicated.There was 1 pass with the device.It was noted the patient's vessel tortuosity was moderate.The access vessel was the femoral artery with 7.6mm diameter.Stroke onset to reperfusion time was 6 hours.No patient symptoms or further complications were reported as a result of this event.It was reported that the sab-6-30 stent was used during thrombectomy.When the doctor pulled the stent back into the react71 suction catheter, the stent accidentally detached in the react71 catheter.The reported devices and any accessory devices were prepared and catheter was flushed as indicated in the ifu.

Manufacturer Narrative

H3: product analysis #705545000: equipment used: vis (m-81805), 203cm ruler (m-83360).Drawing(s) referenced: none.As found condition: the react-71 catheter (pli-20), rebar-18 catheter (pli-30), and solitaire ab stent device (pli-40) were returned for analysis within a shipping box and within plastic bio-pouches.The react-71 catheter (pli-20) was returned within an opened react 71 inner pouch (b435065) and within a dispenser coil.The rebar-18 catheter (pli-30) and solitaire ab stent device (pli-40) were returned within an opened solitaire ab inner pouch (b442721) and within a dispenser coil.The solitaire ab stent device (pli-40) was returned within the rebar-18 catheter (pli-30).Damage location details: (pli-20) ¿ no damages were found with the react-71 catheter hub.The react-71 catheter body was found kinked at ~17.5cm from the proximal end of the catheter hub.The distal ~19.5cm of the react-71 catheter body was found stretched.The react-71 catheter distal tip was found intact.The solitaire ab stent (pli-10) was observed to be stuck within the react-71 catheter at ~13.0cm from the catheter distal end.The react-71 catheter was dissected (cut) to remove the solitaire ab stent (pli-10).The solitaire ab stent non-working length struts were found damaged (bent).The stent's working length struts were found to be in good condition.The stent keyway finger struts were found fractured/separated.The solitaire ab stent was found separated from the pusher, and the pusher was not returned.(pli-30/40) ¿ the solitaire ab pusher was found extending out from within the rebar-18 catheter hub for ~27.4cm.The rebar-18 catheter distal tip was found damaged (kinked).The solitaire ab stent device was pushed out from within the rebar-18 catheter without issue.No bends or kinks were found with the solitaire ab pusher or marker coil.The stent was found still attached to the pusher.The stent non-working and working length struts were found to be in good condition.Testing/analysis: (pli-10) the solitaire ab stent was sent out for sem (scanning electron micrographic) failure analysis.Per the sem report, one strut broken end failed via fatigue then overload.The other strut's broken end failed via ductile overload.Conclusion: (pli-10) based on the device analysis and reported information, the customer's "premature detachment/separation" report was confirmed as the stent was found separated from the pusher.Device separation can occur due to delivery and retrieval friction, a higher number of device passes, guide catheter integrity issues such as kinking, the presence of a pre-existing extra/intracranial stenosis or calcified plaque, presence of hard clots/thrombus entanglement with overbending during the retraction process, the proximal end of the solitaire device not aligning with the microcatheter, or removal of the microcatheter prior to retrieval of the solitaire device with or without clot.There was one pass made with the device, ruling out a "higher number of device passes" as a potential cause.It is possible the damage found with the returned react-71 catheter (stretching) contributed to the reported event.Catheter damage can occur if advanced/retrieved against resistance or an intralumenal device is advanced/retrieved against resistance.However, the cause for the catheter damage could not be determined.Information regarding if there was any delivery or retrieval friction, presence of a pre-existing extra/intracranial stenosis or calcified plaque, if the proximal end of the solitaire device was aligned within the microcatheter, or if the microcatheter was removed prior to solitaire retrieval was not reported.However, as the sem report indicated, the stent strut failed via fatigue and then overload this likely indicates the strut became bent before breaking.However, the cause of the device separation could not be determined due to insufficient information.(rosaj10 2023-07-28).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 AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• 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: 17603703
• MDR Text Key: 321749309
• Report Number: 2029214-2023-01462
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAB-6-30
• Device Catalogue Number: SAB-6-30
• Device Lot Number: B442721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• 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