MAUDE Adverse Event Report: MEDINOL NIRXCELL 3.5X17 US; CORONARY DRUG-ELUTING STENT

Catalog Number NXL35017US

Device Problem Occlusion Within Device (1423)

Patient Problems Cardiac Arrest (1762); Death (1802); Thrombosis (2100)

Event Date 10/16/2017

Event Type  Death  

Event Description

This complaint is from (b)(6) (post approval study).As reported, six hundred two (602) days after successful implantation of a nirxcell 3.5 x 17 us stent, the patient experienced cardiac arrest.The patient was brought to the emergency room (er) by emergency medical services (ems) in full cardiac arrest with cardiopulmonary resuscitation (cpr) in progress after the family reported the patient passing out at home.Vital signs were 92.8 t, unlabored, 74/40.The subject was intubated, chest compressions initiated and acute cardiac life support (acls) protocol was initiated.The patient expired in the er.In the investigator's opinion, the event of cardiac arrest was considered severe in intensity, unrelated to the study device and unrelated to the study procedure.The sponsor considered the event of cardiac arrest anticipated, possibly related to the study device and unrelated to the index procedure.Sponsor comment: the subject presented to medical facility in cardiac arrest with ongoing cpr.Idioventricular rhythm.Cause of arrest unknown.The patient¿s index procedure was due to stable angina (ccsc ii).A nirxcell 3.5 x 17 us stent was deployed in the mid left anterior descending (lad) target lesion.The target lesion was reported to be: de novo, a seventy-five percent (75%) stenosis, not calcified, and grade 3 timi flow.The residual stenosis was zero (0%) and the flow was timi 3.The patient¿s ejection fraction (ef) at the time of the index procedure was fifty-five percent (55%).Additional information received indicated that no autopsy was performed.The cause of death was reported to be cardiac arrest.The patient was on antiplatelet therapy and was compliant with the medical regimen.No additional information is available.Please note that due to system limitations, the type of reportable event was selected.Pursuant to the fda code of federal regulations, (b)(4) is an importer of nirxcell¿ coronary stent system, a distributed product made by medinol.Therefore, (b)(4) is required to report all complaints of deaths and serious injuries to the fda associated with this product.

• Brand Name: NIRXCELL 3.5X17 US
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL; 8th hartom st. beck-tech bldg; p.o.b. 45026; jerusalem ; IS
• MDR Report Key: 7562136
• MDR Text Key: 109830670
• Report Number: 1016427-2018-01512
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/08/2018,06/01/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: NXL35017US
• Device Lot Number: NUS00113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2018
• Distributor Facility Aware Date: 05/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81MG QD, PLAVIX 75 MG QD, BYSTOLIC 5 MG QD
• Patient Outcome(s): Death
• Patient Weight: 81