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

Model Number	3.5X17
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Reported on (b)(6) 2016: short description: tracking difficulties (inside patient).Description: "a nirxcell 3.5x17 lot nus00117 stent was advanced toward the mid rca lesion but it wouldn't cross the lesion.It was removed from the body intact.Outside the body, it was noted to be somewhat loose on the delivery balloon and was discarded.The mid rca lesion was then predilated with a 3.5 balloon and a new 3.5x17 nirxcell was successfully placed across the mid rca lesion.A second stent, nirxcell 3.5x12, was deployed successfully in the proximal rca lesion." the device was used in acute mi.There was no harm / injury to patient.Additional classifications: stent lost off balloon (outside patient), stent uncrimped on balloon (outside patient).Additional information was received on september 28, 2016: the device was removed from its packaging and it looked normal.It was inspected and prepped properly.No issues were noted.When the doctor was removing the stent delivery system and the tip had completely exited the touhy, the doctor looked down to tighten the touhy and he saw the stent off the balloon on the stent delivery system catheter.Complaint classification based on the information: stent delivery system, failure to cross, in patient; stent, partially dislodged, outside patient.
Event or Problem Description
Additional information on oct 20, 2016: the delivery system was retracted through the guiding catheter and was removed by itself not with the guiding catheter.Additional information on october 31, 2016: results of the device investigation together with the customer report indicate that the returned product was supplied meeting specifications.No anomalies were detected that could elucidate the circumstances for the customer reported failure to cross and subsequent stent dislodgement after removal of the system from the patient.It may be surmised that the reported issues are not related to medinol manufacturing processes.Device investigation report is attached.Additional information on november 8, 2016: instructions for use was reviewed.The review noted that the system was retracted back through the guiding catheter and not together with the guiding catheter as indicated in the ifu.In addition nirxcell was used in the acute myocardial infarction which is not indicated in the instructions for use.Dhr review revealed no new information that would change the initial report.The report is attached.The following information was inadvertently omitted from the initial mdr report:de novo, 70% stenosis.Lesion calcification was high and vessel calcification medium.Timi flow before procedure 3, after procedure 3.

• Brand Name: NIRXCELL COCR CORONARY STENT ON RX SYSTEM
• Common Device Name: CORONARY, STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, jerusalem 97775 08; IS 9777508
• MDR Report Key: 6025458
• Report Number: 3003084171-2016-00004
• Device Sequence Number: 10776774
• Product Code: MAF
• UDI-Device Identifier: 07290107010955
• UDI-Public: 07290107010955
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2016

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: 01/31/2017
• Device Model Number: 3.5X17
• Device Catalogue Number: NXL35017US
• Device Lot Number: NUS00117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/13/2016
• Supplement Report FDA Received Date: 11/15/2016; 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1