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

Model Number	2.5X17
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
The physician had passed the nirxcell stent past a proximal / mid rca lesion that the xience stent would not pass.Upon passing the lesion the physician began the inflation of the nirxcell stent and quickly noticed that blood was filling up the endoflater.The physician immediately stopped as it was apparent that the balloon the stent was crimped to was defective or something and he removed the nirxcell.Upon removal he noticed that the nirxcell stent was scrunched all the way to the distal end.He then opened 3 more nirxcell stents with no issues and finished the case.No patient injury reported.
Event or Problem Description
Additional information received on apr 08, 2018: i had initially tried to pass a xience stent with the intent of stenting the distal rca.It did not pass because it was getting 'caught' on a proximal stent (mild tortuosity was present but nothing unusual).I then decided to try the nirxcell stent given its excellent deliverability.It passed into position with zero resistance.The stent was prepped at the lesion site, which had already undergone angioplasty.Upon inflating (i had planned to deploy at 12 atm), the pressure gauge did not advance.I thought maybe there was a leak in the hook-up so i checked the attachments, which were all tight.I stepped on fluoro again, and the balloon was not inflated at all.I had the tech pull negative, and blood came back into the inflation device syringe.The stent was 'mangled' into the balloon and had perforated it.There had been no noticeable defect prior to insertion, and it passed without any difficulty whatsoever as noted above.
Additional Manufacturer Narrative
The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
Additional information received: ifu review (may 23, 2018).Device analysis (may 27, 2018).Final report (may 28, 2018).

• 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: 7395280
• Report Number: 3003084171-2018-00006
• Device Sequence Number: 16155406
• Product Code: MAF
• UDI-Device Identifier: 07290107010771
• UDI-Public: 07290107010771
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P110004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

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: 04/30/2019
• Device Model Number: 2.5X17
• Device Catalogue Number: NXL25017US
• Device Lot Number: NUS01022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/08/2018; 05/10/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/29/2018; 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1