MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER; CATHETER, PERCUTANEOUS

Model Number UNK-NV-RFX

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

Patient Problems Fistula (1862); Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426)

Event Date 07/31/2019

Event Type  Injury  

Event Description

James yeomans, lilian sandu, and anand sastry; the neuroradiology journal; 2020; 33(6) 471¿478; pipeline flex embolisation device with shield technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes; doi: 10.1177/19 71400920966749journals.Sagepub.Com/home/neu.Medtronic received information in a literature article that complication including stroke, dissection, and foreshorting occurred with third generation pipeline flex with shield and navien catheter.  this prospective, single-arm study reviewed a total of 31 patients (26 patients were women) with 32 aneurysms, 28 of which were treated electively and four of which were treated acutely, over a 21-month time period between 1 october 2017 and (b)(6) 2019 at a tertiary centre for interventional neuroradiology. the pipeline shield is supplied in multiple sizes, from 2.5mmx10mm to 5mmx35 mm.Pipeline sizing is aided by the use of the software application sim size. the mean age of the cohort was 58.8 years.The elective cases received dual antiplatelet therapy post-procedure.The acute cases received single antiplatelet therapy post-procedure.Of the target aneurysms, 16/32 (50%) were small 10 mm), 13/32 (41%) were large (10¿25 mm) and 3/32 (9%) were giant (> or = 25 mm).There were three aneurysms treated with a second pipeline shield device due to fore-shortening of the first device post-deployment or suboptimal neck coverage. there was no post-procedure mortality in the series. however, one patient had a hemorrhagic stroke affecting the left-sided basal ganglia and left temporal lobe. the stroke occurred during a complex procedure. the patient presented with a wide-necked 20mm x15mm left posterior communicating artery aneurysm. a navien catheter was advanced to the left internal carotid artery (ica).The left ica was dysplastic and narrowed in several segments.Two pipeline shield devices were deployed across the neck of the aneurysm.The second device was required due to immediate foreshortening of the device and subsequent migration following angioplasty. the aneurysm was coiled through an echelon microcatheter.Attempts to widen the dysplastic left ica led to the formation of a traumatic left carotico-cavernous fistula. the patient woke up with a right-sided neurological deficit.Ct imaging demonstrated a left-sided basal ganglia and left temporal lobe intracranial hemorrhage, probably secondary to wire perforation.A ct angiogram showed the pipeline device remained patent and correctly sited.The patient underwent neurorehabilitation and had moderate disability.  another patient experienced a dissection which occurred during an elective procedure. this patient underwent flow diversion of a large 8mmx10mm right posterior communicating artery recurrence that had previously been coiled twice.There was a small clot at the distal end of the pipeline device due to poor opposition.The distal end of the device was balloon angioplastied with good apposition.During this maneuver, there was dissection of the petrocavernous segment of the ica by the advancing tip of the intermediate catheter.A single solitaire stent  sized 6mmx30mm was deployed across the dissection, reopening the vessel.The patient woke up with no new neurological deficits.

Manufacturer Narrative

See attachments for literature article.Event related to regulatory report: 2029214-2022-00168.If information is provided in the future, a supplemental report will be issued.

• Brand Name: REFLEX CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 13476725
• MDR Text Key: 288797139
• Report Number: 2029214-2022-00169
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-RFX
• Device Catalogue Number: UNK-NV-RFX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2022
• 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): Disability; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female