MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-REBAR

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Intracranial Hemorrhage (1891); Obstruction/Occlusion (2422); Respiratory Insufficiency (4462)

Event Date 11/16/2014

Event Type  Injury  

Manufacturer Narrative

Akpinar s, yilmaz g.Spontaneous solitaire¿ ab thrombectomy stent detachment during stroke treatment.Cardiovascular and interventional radiology.2015;38(2):475-478.Doi:10.1007/s00270-014-1022-y.If information is provided in the future, a supplemental report will be issued.

Event Description

Akpinar s, yilmaz g.Spontaneous solitaire¿ ab thrombectomy stent detachment during stroke treatment.Cardiovascular and interventional radiology.2015;38(2):475-478.Doi:10.1007/s00270-014-1022-y.Medtronic literature review found a report of patient complications in association with a solitaire ab.The purpose of this article was to present the case of spontaneous solitaire stent retriever detachment during stroke treatment for a middle cerebral artery m1 occlusion resulting in progressive thrombosis.The following intra- or post-procedural outcomes were noted: after reaching the occlusion site using a rebar 27 microcatheter, the solitaire ab was distally unsheathed and allowed 4 min to deploy.While drawing the deployed retriever stent, resistance to withdraw was noticed and they partially resheathed the stent into the delivery microcatheter to free the stent where it was entangled.During this maneuver, the thrombectomy stent spontaneously detached.Following control runs, the thrombus progressed from the occlusion at the mca medioinferiorly to the distal ica segment without responding to two consecutive infusions of abciximab.Because there was no recanalization at the occlusion site and access distal to the detached stent with the micro guidewire was not achieved, the proximal branch of the mca was catheterized and another solitaire stent was deployed to capture the first stent.After two unsuccessful attempts through the mca route, the right anterior cerebral artery (aca) a1 segment was catheterized.The distal markers of the second stent deployed at the aca a1 segment caught the proximal strands of the detached first stent, and removal of both stents was achieved using the 8fr guiding catheter.After this maneuver, the occluded mca m1 segment was recanalized, resulting in a tici score of 2b.The patient was kept in an intensive care unit because of poor oxygen saturation.A ct after 6 hours showed a non-progressive ecass hi type 2 hemorrhage at the right putamen, and a right mca repeat stroke, which was assumed due to atrial fibrillation and low ejection fraction.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 13403488
• MDR Text Key: 289196027
• Report Number: 2029214-2022-00127
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-REBAR
• Device Catalogue Number: UNK-NV-REBAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male