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

Model Number SRD3-4-40-10

Device Problem Break (1069)

Patient Problem Paralysis (1997)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

The solitaire stent will not be returned as it was lost; however, the pushwire is expected to be return.Upon receipt of the device, a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that solitaire stent separation occurred during the procedure.The patient underwent thrombectomy treatment for a middle cerebral artery (mca) occlusion + severe stenosis at internal carotid artery origin.It was reported that the patient in conscious sedation, aspiration and stent retrieval (sr) attempt was performed 3 times with non-medtronic preset 4\20 without success.Due to agitation patient got general anesthesia (ga), and then a carotid occlusion was seen.Pta and aspiration didn¿t succeed to open the internal carotid artery (ica).500 mg iv aspirin was administered followed by a thrombectomy attempt to the mca with a solitaire stent through a medtronic catheter.During retrieval aspiration of the solitaire and non-medtronic guide catheter, solitaire stent was detached approximately 5cm from the radiopaque proximal marker.Digital subtraction angiography (dsa) showed the detached srd3 from the m2 to ica with no flow to the m1.Snaring and percutaneous transluminal angioplasty (pta) attempts followed for solitaire retrieval with no success.A new srd2-4-20 was used to snare the unintended detached srd3 with success.Dsa showed an mca lower branch open and upper branch occluded and distal anterior cerebral artery (aca) occlusion.Complete ica occlusion lead to 3 unsuccessful attempts to pta this occlusion.Ct post showed no subarachnoid hemorrhage (sah) at mca region, with distal pre central sulcus suspected sah.Patient was transmitted to nicu intubated and ventilated.2 days post procedure patient is awake, talking with left arm & leg hemiplegia.The patient pre-existing condition - nihss 0 the patient current medical condition - nihss 10.

Manufacturer Narrative

The solitaire platinum pushwire was returned without the stent as it was lost after it was removed from the patient anatomy.The solitaire platinum pushwire was decontaminated.The solitaire platinum pushwire total length was measured and found broken at the distal end.The end with the broken wire was cut and sent out to element labs for scanning electron microscopy (sem) analysis.No other anomalies were observed.Based on the report of ¿separation¿, the event was confirmed.Per the sem analysis report, the crack was initiated via fatigue.Most of the fracture failed via ductile overload.Based on the investigation conducted, device separation can occur due to anatomical considerations such as level of tortuosity or variants of anatomy at the aortic arch or neurovasculature, delivery and retrieval friction, resistance where the forces applied to the binding of the solitaire device may be greater, higher number of device passes, guide catheter technique, guide / balloon catheters or intermediate catheter integrity issues such as kinking within the shaft, presence of a pre-existing extra/intracranial stenosis or calcified plaque, presence of hard clots / thrombus entanglement with overbending during the retraction process, alignment of the microcatheter with the proximal end of the solitaire device, removal of the microcatheter prior to retrieval of the solitaire device with or without clot.Information on delivery and retrieval friction, and removal of the micro catheter prior to retrieval of the solitaire device was not given therefore any contributing factors could not be assessed.In this event it is likely the patient¿s ¿severe stenosis¿ caused the solitaire device separation.Per the instructions for use (ifu): contraindications - patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the solitaire¿ platinum revascularization device.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 PLATINUM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9538059
• MDR Text Key: 207390195
• Report Number: 2029214-2020-00003
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K153071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: SRD3-4-40-10
• Device Lot Number: A828842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 69 YR