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

Model Number	2.75X17
Medical Device Problem Codes	Bent (1059); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation in progress.
Event or Problem Description
Event description: per (b)(6), the cath lab supervisor in (b)(6).During lhc turned into pci, after predilating lesion a new 2.75 x 17 nirxcell stent was opened.The device was properly handled and the physician (b)(6) delivered the device.It was noted that there was no stent in the vessel.The stent was located on the scrub table.It never entered the body.Dr.(b)(6) properly handled the stent.The team also properly handled the stent to dr (b)(6).The location of lesion is lhc/pci.There was no harm to the patient.Additional information was received on nov 24, 2016: during inspection prior to use nothing appeared abnormal, except the physician did not notice that the stent was not on the balloon, he said he will check this more carefully in the future, he assumes now that maybe the stent was not crimped properly onto the delivery system.The product was prepped according to ifu.There were no problem during preparation.There was no resistance experienced while tracking the stent deployment system to the lesion nor when crossing the lesion.Upon visualization in the patient anatomy it was noticed that there was no stent visible so the staff began searching for the stent and found it on the table, they were initially concerned that the stent may have been lost in the patient anatomy but were relieved to find that it never entered the patient's body.The stent was located on the sterile table where the delivery system was prepped.
Additional Manufacturer Narrative
Device history record review, ifu review, stent securement investigation report (b)(4) and final report (b)(4) attached.

• Brand Name: NIRXCELL COCR CORONARY STENT OM RX SYSTEM
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, jerusalem 97775 08; IS 9777508
• MDR Report Key: 6131738
• Report Number: 3003084171-2016-00008
• Device Sequence Number: 970666
• Product Code: MAF
• UDI-Device Identifier: 07290107010818
• UDI-Public: 07290107010818
• 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,Followup
• Report Date (Section B): 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: 2.75X17
• Device Catalogue Number: NXL27517US
• Device Lot Number: NUS00101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 12/20/2016; 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1