MAUDE Adverse Event Report: MEDINOL LTD. NIRXCELL 3.5X20 US; STENT, CORONARY

Model Number	NXL35020US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	07/01/2017
Type of Reportable Event	Death
Event or Problem Description
As reported, the patient underwent index procedure with deployment of nirxcell (3.5x20 us) stent system in the mid lad due to unstable angina.Approximately one year later, 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 7.4i, p02 of 242, co2 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 showed lad: ostial 80% stenosis and proximal 60% stenosis.The patient underwent a successful pci of ostial and proximal/mid lad with bms no residual stenosis.The patient had recurrent intra-procedure v-fib which was successfully defibrillated, final av paced rhythm.An ecg showed atrial-sensed ventricular-paced rhythm with prolonged av conduction, ventricular rate 70 8pm, pr interval 304ms, qrs duration 216 ms qt/qtc 536/578 ms.The next day, the patient 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-and-chronic renal failure, multiorgan failure, shock, markedly reduced l vef with respiratory failure.On the same day, no pulse or respirations, the patient was pronounced dead.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 possibly related to device.The patency of the study stent was not specifically described in the cath report.
Additional Manufacturer Narrative
Per additional information received, the clinical events previously reported is not related to the nirxcell stent nor the procedure.Therefore, the events described were considered a non-complaint.

• Brand Name: NIRXCELL 3.5X20 US
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem 97775 08; IS 9777508
• MDR Report Key: 7504917
• Report Number: 1016427-2018-01446
• Device Sequence Number: 1788627
• Product Code: MAF
• UDI-Device Identifier: 07290107010962
• UDI-Public: 07290107010962
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018
• Report Date (Section F): 05/10/2018

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: NXL35020US
• Device Catalogue Number: NXL35020US
• Device Lot Number: NUS00109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR