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

Model Number	3.0X12
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombus (2101); Stenosis (2263)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available, dhr review is attached.
Event or Problem Description
(b)(6) male patient who is active drug user (heroin) had high risk bifurcation lesion at mid lad and 2nd diagonal branch; one 3.0 x 17 nirxcell was successfully deployed at mid lad.However, plaque shifted distally creating the need for a second stent placement.At that time, a second nirxcell size 3.0 x 12 was selected to be placed distal to the 3.0 x 17 but was unable to recross the just deployed 3.0 x17.The physician pulled out the 3.0 x 12 nirxcell and was able to successfully deploy a 3.0 x 12 stent from other company which did recross the just deployed 3.0 x 17 nirxcell.Procedure was then completed with other company's stent size 2.5 x18 deployed in the 2nd diagonal.Staff noted that they had difficulty keeping patient still which resulted in patient losing his iv and repeated attempts to introduce heparin were unsuccessful as a result they were unable to get act to target.The lost iv was noticed at completion of case as a puddle of heparin solution was found on the floor.Per the rn and rt in the case, this likely led to the thrombus that occurred during the procedure while trying to deliver the 2nd nirxcell stent (3.0 x 12).Patient's blood was in a hypercoaguable state due to the lack of heparin being introduced in the body.Hospital staff do not believe that the attempted delivery of the second nirxcell stent caused the thrombus.Location of lesion: mid lad, de novo, stenosis 85%, bifurcation, pre-existing clot, lesion and vessel calcification low.The vessel was not tortuous.There was pre-dilation with pressure of 12.Stent dilation pressure was 14.There was post dilation with pressure 14.Timi flow before procedure 2 and after procedure 3.There was no injury to patient.Further information was received on (b)(6) 2017: the doctor does not attribute the thrombus to nirxcell.He administered reopro after the thrombus appeared after nirxcell stent 3.0x17 was deployed successfully.The doctor felt the tip catching and hanging up on the struts of the newly deployed 3.0x17 nirxcell, and he believes that this was the issue behind not being able to recross and successfully deploy the second nirxcell 3.0x12.Further information was received on (b)(6) 2017: the patient presented with a stemi.

• 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, 97775 08; IS 9777508
• MDR Report Key: 6525274
• Report Number: 3003084171-2017-00011
• Device Sequence Number: 11079789
• Product Code: MAF
• UDI-Device Identifier: 07290107010870
• UDI-Public: 07290107010870
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2017

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: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: 3.0X12
• Device Catalogue Number: NXL30012US
• Device Lot Number: NUS00186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/28/2017
• 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: Required Intervention
• Patient Age: 51 YR