MAUDE Adverse Event Report: MEDINOL LTD. ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number	4.0X20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event was re-evaluated on (b)(6) 2018 and assessed as mdr reportable.Attached documents: ifu review.Device analysis report.[ifu review.Pdf, device analysis report.Pdf, lnrus17 fr.Pdf].
Event or Problem Description
After successfully deploying the elunir 4.0 x 20mm stent, the stent balloon was used to post-dilate the proximal portion of the stent.When the balloon was about to be removed after post-dilatation, it got stuck into the wire.It seemed like the balloon and the wire were fused together.Both the wire and the balloon were eventually removed and both items (bmw wire and the elunir stent) will be returned for evaluation.No reported patient injury.Additional information received on march 09, 2018: the product was stored properly according to the instructions for use (ifu); there was no damage noted to the product packaging upon inspection prior to use; there was no reported difficulty removing the product from the packaging; the product, or any of the other devices used with were not resterilized; the device was prepped according to instructions for use (ifu); no anomalies were noted during or after the device was prepped; it was verified prior to insertion that stent was contained within the outer sheath/introducer of the system; the guidewire port was flushed as outlined in the ifu prior to loading on the guidewire; the device was removed intact (in one piece) from the patient; additional information received on march 10, 2018: location of (b)(6) characteristics: it was an in stent restenosis; pre-dilation preformed at 16atm; 20atm was used to inflate the stent balloon; no balloon inflation difficulty or deflation difficulty; size/brand of guide catheter: 7f jr4 with sideholes; size of guide wire used:.014; no excessive force was applied on the stent delivery system while inserting it over the guide wire; the guide catheter exhibited no kinks/bends; no excessive force was applied to the device during withdrawal; the physician check whether there was any damage to the stent delivery system after removing the protective sleeve with shipping mandrel; the preparation of the system was preformed according to the ifu; the stent was successfully deployed, the issue was the stent balloon got stuck to the wire when they used it to post-dilate the proximal portion of the stent; the physician was trained on the product; angiogram is unavailable; the system is available for analysis; patient condition after procedure: patient was ok there was no negative impact on the patient at all.
Event or Problem Description
Information received on apr.11, 2018: the product was stored and handled according to the instructions for use (ifu); there was no damage noted to the packaging of the device; the device was stored on a cart in the cath lab and the consignment was relatively new.There was no difficulty removing the product from the hoop; there was no difficulty removing the protective balloon cover; there was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient; the device was prepped normally (i.E.Maintained negative pressure); the same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve; there was no resistance/friction while inserting the balloon through the guide catheter.Vessel / lesion characteristics: nothing unseal there was no difficulty advancing the balloon catheter through the vessel; there was no difficulty crossing the lesion.; the catheter was not in an acute bend; the balloon deflated normally; the balloon re-wrapped properly; the catheter appeared to be caught on the wire.They were not able to walk off the catheter off the wire after the stent was deployed.The balloon catheter did not kink while being used; it was not easy to remove the balloon catheter: the stent deployment system, sheath and guide needed to be removed all as one.The product was removed intact (in one piece) from the patient.Patient condition at present is stable.

• Brand Name: ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 7449967
• Report Number: 3003084171-2018-00009
• Device Sequence Number: 1575505
• Product Code: NIQ
• UDI-Device Identifier: 07290107013901
• UDI-Public: 07290107013901
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P170008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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 Model Number: 4.0X20
• Device Catalogue Number: LUN400R20US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR