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

Model Number	4.0X33
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After reviewing the file on apr.30, 2018, a complaint classification was added: stent delivery system, withdrawal difficulty, in patient.This classification changed the status of the complaint to "reportable".Dhr review, ifu review, final report, device analysis.
Event or Problem Description
A case was reported in which the spring tip stretched out while taking out the balloon, after a 4.0 x 33 deployment.There was no patient injury.Additional information received on february 27, 2018: the target lesion was in the mid right coronary artery (rca), the lesion was tight and severely tortuous, calcification unknown.The product was stored properly according to the ifu.No damage to the product packaging was noted upon inspection prior to use.No difficulty was reported removing the product from the packaging.The device was prepped according to ifu.No anomaly was noted during or after the device was prepped.The product, or any of the other devices used with it, had not been re-sterilized.The guidewire port was flushed as outlined in the ifu prior to loading on the guidewire.Size sheath used was 6 and guide wire 0.014.Prior to inserting the stent delivery system (sds) in the catheter, the balloon was not inflated or partially inflated.Negative pressure was applied to the sds.The balloon was sticking and difficult to remove from the patient, it took a couple of attempts.When the spring was coming out of the sheath, the physician noticed that something seemed wrong, so he told the technician to stop pulling out the sds.The physician pinched down on the very tip of the spring, which was slightly stretched, but the scrub tech didn't stop pulling so the tip stretched further.This happened outside the body.It was confirmed that the balloon was fully deflated prior to withdrawal.It is unknown whether the inflation device was in the neutral position when the system was being advanced/withdrawn.It is unknown whether the negative pressure was maintained on the inflation device during withdrawal of the system.The device was removed intact (in one piece) from the patient.The procedure was successfully completed.

• 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, israel 97775 08; IS 9777508
• MDR Report Key: 7517499
• Report Number: 3003084171-2018-00020
• Device Sequence Number: 13799391
• Product Code: NIQ
• UDI-Device Identifier: 07290107013963
• UDI-Public: 07290107013963
• 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
• Report Date (Section B): 02/21/2018

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: 11/30/2019
• Device Model Number: 4.0X33
• Device Catalogue Number: LUN400R33US
• Device Lot Number: LNRUS00059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1