MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE FR; CATHETER, THROMBUS RETRIEVER

Model Number SFR-4-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

The mechanical thrombectomy device was not returned for analysis.Attempts have been made to obtain additional information.However, no response has been received.Based on the reported, the device was successful in re-vascularizing the mca vessel.Therefore, the device performed as intended; as indicated by a successful revascularization of the middle cerebral artery (mca) occluded vessels (tici 2b).The cause of the new left-sided hemiplegia cannot be reliably determined; however, the most likely cause was the pathophysiology of the right mca stroke, the patient underlying medical condition and over consumption of energy (caffeine) drinks.Per the instructions for use: do not perform more than three recovery attempts in the same vessel using revascularization devices.Do not use each revascularization device for more than two flow restoration recoveries.

Event Description

Citation: "aneurysmal subarachnoid hemorrhage and severe, catheter-induced vasospasm associated with excessive consumption of a caffeinated energy drink¿.Sagepub.Co.Uk/journalspermissions.Nav doi: 10.1177/1591019916660868.Medtronic received a report case of aneurysmal sah complicated by severe, catheter-induced vasospasm and symptomatic thromboembolism during attempted endovascular coiling of a ruptured anterior communicating artery (acoma) aneurysm in the setting of excessive energy drink consumption.The patient resented with a sudden-onset, severe headache and past medical history was significant for habitual, excessive energy drink consumption.The patient was anticoagulated with a bolus dose of intravenous (iv) heparin (100 units/kg).Additional doses of iv heparin were administered as needed (activated clotting time (act) maintained >250 throughout the procedure).An exchange maneuver was performed in the right external carotid artery to position a 6f flexor shuttle guiding sheath (cook medical, bloomington, in) into the distal right common carotid artery.From this base position, a neuron 6f 070 delivery catheter (penumbra inc, (b)(4) was positioned in the petrous segment of the right internal carotid artery (ica).An occlusion balloon catheter was positioned in the right a1 segment in preparation for a balloon-remodeling technique.Control runs demonstrated anterograde flow with no evidence of vasospasm.During attempts to navigate the balloon catheter across the neck of the aneurysm, back-and-forth movement of the delivery catheter was observed.Control runs demonstrated severe, flow limiting, delivery catheter-induced vasospasm in the petrous ica.This improved over the course of a few minutes with more proximal repositioning of the delivery catheter.A new, non-flow-limiting filling defect was observed in the right supraclinoid ica with rapid clot migration into the right m1 segment.Soon thereafter, the m1 thrombus spontaneously migrated distally and fragmented into multiple m2/3 vessels.Revascularization of much of the mca territory (thrombolysis in cerebral infarction (tici) 2b) was achieved by administration of 325 mg of aspirin via orogastric tube, infusion of 5mg intra-arterial abciximab (reopro) via a microcatheter placed in the distal m1 segment, optimization of systemic heparinization, and multiple passes with the solitaire fr.An mri of the brain performed immediately postintervention demonstrated a right mca territory stroke.The patient had a new left-sided hemiplegia.The aneurysm was successfully coiled the next day.During the second interventional procedure, ica vasospasm was again encountered, but successfully managed with early recognition, in tra-arterial verapamil administration (10 mg), and more proximal positioning of the delivery catheter.The patient¿s postoperative course was complicated by severe, right mca vasospasm resulting in extension of her right mca stroke, and a left lower extremity deep vein thrombosis on post-sah day 9.At her six-month follow-up, the patient was ambulating normally without the use of an assist device; she continued to have severe right arm and hand weakness that did not improve significantly over time (modified ranking scale (mrs:2).There was no evidence of aneurysm recanalization on contrast-enhanced mr angiogram (three-year follow-up).

Manufacturer Narrative

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): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6650996
• MDR Text Key: 77877240
• Report Number: 2029214-2017-00791
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: SFR-4-20
• Device Catalogue Number: SFR-4-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Disability
• Patient Age: 44 YR