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

Model Number	2.75X15
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr was reviewed on june 19, 2018: all manufacturing and release test documentation is present and meets the requirements.Crimping, crossing profile, and securement measurements are all in compliance with the product requirements.All the released systems met specifications.
Event or Problem Description
During a case observation, the balloon on this elunir stent failed to release from the stent/wire after full deflation.The physician then reinflated the balloon to 3 atm and deflated the balloon once again.This time the balloon released from the stent and was able to be removed from the patient.Additional information received on june 19, 2018: the device is not available to return as it was not saved post procedure.Additional information received on june 27, 2018: the product was stored and handled according to the instructions for use (ifu).Device has bees stored in the cath lab.In the lab, the device has been stored on a shelf placed upright on an edge with the product info facing outward.No damage was noted to the packaging of the device.The preparation of the stent delivery system was done according to the ifu.The physician did not check whether there was any damage to the stent delivery system after removing the protective sleeve with shipping mandrel/stylet.There were no kinks or other damages noted prior to inserting the stent delivery system into the patient.The device prepping happened normally, i.E maintained negative pressure.Contrast media used was isovue 370 by bracco.Media contrast ratio used was 50/50 with saline.Brand of guide catheter used was boston scientific lbu 3.5, no kinks/bends observed on the guide catheter.Guide wire: comet ffr wire by boston scientific.Inflation device brand: boston scientific.Target lesion location was mid lad artery, characterised as 70% stenosis.No pre-dilitation performed.No excessive force was applied on the stent delivery system while inserting it over the guide wire was applied.The balloon inflation was performed at 16 atm, and deflated normally.Additional force was required to remove the system.The delivery system removed intact (in one piece) from the patient.No patient injury currently the patient condition is normal.Additional information received on july 8, 2018: there was no difficulty removing the device from the packaging.No excess force used during prep.Target lesion characterised as ramus, untortuous, with 80% stenosis and mild calcification.Guide catheter used was cordis xb 3.5 brand.No damage to guide catheter during the procedure.The guide catheter did not exhibited any kinks/bends.No excessive force was applied on the stent delivery system while advancing it through the guide catheter.Balloon inflation accrued at nominal pressure.Balloon deflated normally, but experienced difficulties in post stent deployment removal.The delivery system removed intact (in one piece) from the patient, but experienced difficulty removing balloon post stent deployment the elunir delivery system was removed when balloon advanced forward slightly and then pulled back into the sheath with slight tension prior to use, the device was stored in the cath lab in a cabinet for 1 week.No excessive force applied to the delivery system during withdrawal.
Event or Problem Description
Initial description of the event as received on (b)(6)2018: during a case observation, the balloon on this elunir stent failed to release from the stent/wire after full deflation.The physician then reinflated the balloon to 3atm and deflated the balloon once again.This time the balloon released from the stent and was able to be removed from the patient.Additional information received on (b)(6)2018:the device is not available to return as it was not saved post procedure.Additional information was also received on (b)(6)2018 and on (b)(6)2018 (both reported in the initial mdr dated (b)(6)2018).As notified by the distributor on (b)(6)2018, only the information received on june 27, 2018 is the correct information.This information appears below: the product was stored and handled according to the instructions for use (ifu).Device has bees stored in the cath lab.In the lab, the device has been stored on a shelf placed upright on an edge with the product info facing outward.No damage was noted to the packaging of the device.The preparation of the stent delivery system was done according to the ifu.The physician did not check whether there was any damage to the stent delivery system after removing the protective sleeve with shipping mandrel/stylet.There were no kinks or other damages noted prior to inserting the stent delivery system into the patient.The device prepping happend normaly, i.E maintained negative pressure.Contrast media used was isovue 370 by bracco.Media contrast ratio used was 50/50 with saline.Brand of guide catheter used was boston scientific lbu 3.5, no kinks/bends observed on the guide catheter.Guide wire: comet ffr wire by boston scientific.Inflation device brand: boston scientific.Target lesion location was mid lad artery, characterised as 70% stenosis.No pre-dilitation performed.No excessive force was applied on the stent delivery system while inserting it over the guide wire was applied.The balloon inflation was performed at 16atm, and deflated normally.Additional force was required to remove the system.The delivery system removed intact (in one piece) from the patient.No patient injury.Currently the patient condition is normal.This clarification serves as the trigger for this follow-up mdr.
Additional Manufacturer Narrative
Ifu review was done (b)(6)2018: no deviation of ifu was reported.Final report (b)(6)2018 overall conclusions: 1.The review of the dhr (device history record) together with the customer report indicates that the product was supplied meeting specifications.2.There is no evidence to suggest that there were any manufacturing issues that contributed to the reported event.3.The investigation was limited as we did not receive the used product.It is not possible to reach a definite conclusion as to how and why this event happened with the information that we received.4.There was no injury to patient and the condition of patient is normal.

• 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: 7682615
• Report Number: 3003084171-2018-00033
• Device Sequence Number: 848513
• Product Code: NIQ
• UDI-Device Identifier: 07290107013611
• UDI-Public: 07290107013611
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2018

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: No Information
• Device Expiration Date: 10/31/2019
• Device Model Number: 2.75X15
• Device Catalogue Number: LUN275R15US
• Device Lot Number: LNRUS00041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 100