MAUDE Adverse Event Report: MEDINOL LTD. NIRXCELL COCR CORONARY STENT ON RX SYSTEM; STENT, CORONARY

Model Number	3.5X20
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/01/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
This report is for subject (b)(6), a 6(b)(6) female participating in the (b)(6) study.The (b)(6) study is "a prospective, post-marketing, non-randomized, multicenter, single arm clinical study.This study is designed to collect and analyze additional information about the safety and effectiveness of the nirxcell stent system in the treatment of de novo stenotic lesions in native coronary arteries in the us population." the subject's medical history includes family history of premature coronary artery disease (cad), atrial fibrillation, peripheral vascular disease, hypertension, hypercholesterolemia, hypertension, chronic renal disease, current smoker and lvef 65%.The subject's concomitant medications included: aspirin and clopidogrel on (b)(6) 2016, due to unstable angina the subject underwent index procedure with deployment of nirxcell stent system in the mid lad.On (b)(6) 2017, the subject had out-of-hospital cardiac arrest.According to the er physician, the subject was intubated at the time of presentation.Subsequently she pulled her tube out.He re-intubated her after sedation and gave her iv amiodarone.Her vital signs were blood pressure 96/44, heart rate ventricular-paced in the 80s, underlying atrial mechanism may be atrial fibrillation.Laboratory tests showed abg ph of 7.4 l, p02 of 242, c02 of 34, saturations of 100%.Sodium was 142, potassium 3.3, bun and creatinine 15 and 2.0 respectively.Troponin was 0.571.Cardiac cath at 11:41 showed lad: ostial 80% stenosis and proximal 60% stenosis.The subject underwent a successful pci of ostial and proximal/mid lad with bms no residual stenosis.The subject had recurrent intra-procedure v-fib which was successfully defibrillated, final av paced rhythm.An ecg at 17:11 showed atrial-sensed ventricular-paced rhythm with prolonged av conduction, ventricular rate 70 bpm, pr interval 304 ms, qrs duration 216 ms qt/qtc 536/578 ms.On (b)(6) 2017, the subject remained critically ill and had anasarca.She had ecchymosis marking and diffuse ecchymosis of the left calf site of the intraosseous administration of medications by the paramedic team.In addition she had acute-an-chronic renal failure, multiorgan failure, shock, markedly reduced l vef with respiratory failure.At 17:04, no pulse or respirations, subject pronounced death.Per death certificate, the cause of death was coronary artery disease.In the investigator's opinion, the event of myocardial infarction was considered severe in intensity, unrelated to the study device and unrelated to the study procedure.The sponsor considers the event of myocardial infarction , anticipated, possibly related to the study device and unrelated to the study procedure.Because the study stent was implanted in the mid lad and this event involved ostial and prox/mid lad stenosis, coded as pr to device.The patency of the study stent was not specifically described in the cath report.
Additional Manufacturer Narrative
Device was not returned to manufacturer.
Event or Problem Description
Additional information received: angiogram analysis ((b)(6) 2018):the clinical events are unrelated to the index procedure and study device.Ifu review ((b)(6) 2018):no deviation of ifu was reported.Three (3) events have occurred on the same setting: lad stenosis ((b)(6) 2017); myocardial infarction ((b)(6) 2017); multi-organ failure ((b)(6) 2017).As per the cec adjudication meeting dated (b)(6) 2018: (the revasc for this subject is pending (pending data)).Event term: myocardial infarction myocardial infarction (arc) adjudicated event term: spontaneous mi (target vessel); myocardial infarction (historic definition): non-q wave mi (target vessel); device relatedness: possibly related.Event term: multi organ failure death adjudicated event term: death, cardiac; device relatedness: possibly related.

• Brand Name: NIRXCELL COCR CORONARY STENT ON RX SYSTEM
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, israel 97775 08; IS 9777508
• MDR Report Key: 7482402
• Report Number: 3003084171-2018-00019
• Device Sequence Number: 1543238
• Product Code: MAF
• UDI-Device Identifier: 07290107010962
• UDI-Public: 07290107010962
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 3.5X20
• Device Catalogue Number: NXL35020US
• Device Lot Number: NUS00109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; CLOPIDOGREL
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR