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

Model Number	3.5X33
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The attached dhr review complaint description states that dislodgement occurred during the procedure.The dhr was reviewed on (b)(4) 2016 and on (b)(4) 2016 medinol received additional information stating that no dislodgement occurred.
Event or Problem Description
Event occurred during post market clinical study, (b)(4).Description provided via e-mail from (b)(6) on (b)(6) 2016.(b)(6) reported that they enrolled subject (b)(6) today.This was a single vessel lesion, no stent complications were anticipated, and a non-study stent(s) was used to treat the target lesion.They were able to withdraw the stent and the product will be returned to medinol.Additional information was received on (b)(4) 2016:the study coordinator (sc) reported the following: the nirxcell stent would not cross the lesion, when the operator brought the stent back into the guide catheter, some of the stent struts became raised during pullback.The principal investigator (pi) was able to get stent back into the guiding catheter and remove it from the subject.The event was initially inadvertently reported as sae, but it is not ae or sae.Additional information received on (b)(4 2016: during percutaneous coronary intervention (pci), the nirxcell stent would not cross the lesion.The stent was then being brought back into the delivery system/guide catheter and some of the stent struts began to raise during the pullback.The pi was able to get the stent back into the guide catheter before it worsened and remove from the patient.There was no dislodgement.No patient injury.
Additional Manufacturer Narrative
Medinol is expecting to receive angiographic data.
Additional Manufacturer Narrative
Angiographic evaluation performed.No additional information.Final complaint report #(b)(4).

• 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, jerusalem 97775 08; IS 9777508
• MDR Report Key: 5497698
• Report Number: 3003084171-2016-00002
• Device Sequence Number: 19106481
• Product Code: MAF
• UDI-Device Identifier: 07290107010993
• UDI-Public: 07290107010993
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2016

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: 04/30/2017
• Device Model Number: 3.5X33
• Device Catalogue Number: NXL35033US
• Device Lot Number: NUS00163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/14/2016
• Supplement Report FDA Received Date: 04/19/2016; 06/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1