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

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

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Linked mrds: 2029214-2019-00679, 2029214-2019-00681.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report the literature review of ¿cardiac arrest induced by carotid sinus reflex activation during flow-diverter stent deployment¿ (shunsaku goto, takashi izumi, masahiro nishihori, mamoru ishida, tetsuya ishida, masato otawa, tomoki kawaguchi, ryosuke oshima, asuka kropp, mizuka ikezawa, toshihiko wakabayashi).Case report: a (b)(6) woman was previously diagnosed with right multiple internal carotid artery (ica) aneurysms, and her status was yearly monitored as an outpatient.A coil embolization had been performed for the anterior choroidal artery aneurysm; after 6 months, the residual ica aneurysms were treated using ped deployment.She was started on double antiplatelet agents (clopidogrel 75 mg/day and aspirin 100 mg/day) beginning 14 days before intervention.Ped deployment was performed under local anesthesia via femoral puncture.She was intravenously administered pentazocine (15 mg) and hydroxyzine pamoate (25 mg) before the femoral puncture; afterward, she was administered dexmedetomidine hydrochloride 0.3 g (after an initial loading of 5 g for 5 minutes) for mild sedation.An 8-french roadmaster (goodman, aichi, japan) was placed in the right cervical ica using a 6-french envoy (cerenovus, new brunswick, new jersey, usa) and 4-french hk inner catheter (hanako, saitama, japan).The marksman (medtronic) was triaxially advanced through a 5-french navien (medtronic).The navien was placed in the cavernous segment of the ica, and the marksman was then navigated to the second segment of the middle cerebral artery.The patient¿s blood pressure and heart rate at that time were 110/70 mm hg and 66 bpm, respectively.A pipeline flex (4 x16 mm) was inserted and deployed from the proximal end of the ica posterior communicating artery bifurcation.During the deployment, cardiac arrest occurred when the navien and marksman were pushed farther to promote adequate opening and apposition of the ped against the vessel wall and increase the neck coverage by the device.Immediately before the arrest, her blood pressure and heart rate were 90/50 mm hg and 60 bpm, respectively.By pulling the delivery system back down and reducing tension to the carotid sinus, a normal sinus rhythm was immediately restored; the cardiac arrest lasted approximately 30 seconds.The procedure resumed after administration of intravenous atropine (0.5 mg), with care not to excessively push the system.Neither severe hypotension nor bradycardia were observed for the remainder of the procedure, and after successfully deploying the ped, a postoperative neurologic examination was negative.Because her modified rankin scale score was negatively affected, she was discharged on postoperative day 4.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8759817
• MDR Text Key: 150017889
• Report Number: 2029214-2019-00680
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• 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): Required Intervention
• Patient Age: 60 YR