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

Model Number 2.50 X 24

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Dhr (device history records) review (dated nov.13, 2019): dhr review indicates that the system successfully passed the release tests.

Event Description

Reported event description, initially was received by the manufacturer on oct 30, 2019 and had the following information: "as reported: defective device" the event happen out the us, in (b)(6).Additional information received on nov 7 stated the following: no patient information available.The intended procedure was ptca.The target lesion was lad.The lesion calcification was described as normal with moderate vessel tortuosity.The device stored and handled as per the instruction for use.No damage was noted to the packaging of the device.The device was preped as per the ifu.By initial description, the word "defective" have meant : "the stent appeared already unfolded on the guidewire before to be in the correct position to deploy it in to the vessel.The operator felt some friction during the entrance into the catheter and into the vessel so he removed to check the situation and he saw the stent unfolded." the malfunction was noted during use.Per initial reporter input, the procedure was extended: "only the time to understand that there was something wrong and then to change stent twice " the event did not cause a condition that required hospitalization or significant prolongation of existing hospitalization.The procedure was completed by implanting a different stent.The device will not be returned for evaluation - the operator threw it.Following a continuous correspondence with the distributor, a revised case detail report was received (nov 17): "as reported, a 2.5mm x 24mm ridaforolimus eluting (elunir) stent was defective.The physician felt some friction during the insertion into the catheter and to the vessel, upon removal of the stent to check the situation, it was noted to be not mounted on the balloon but not expanded.After the device was retrieved, the stent was entirely dislodged and the operator had to change the stent and use another elunir stent however, it got stuck on the unknown guidewire and impossible to be deployed.Therefore, it was replaced with another elunir stent and the procedure was completed.This situation occurred during navigation across the catheter or the artery because the physician doesn't know before inserting into the catheter.There was no reported patient injury.The devices were stored and handled as per the instruction for use (ifu).There were no damages noted to the packaging of the device.The stents were perfectly mounted in the package.The devices were prepped as per the ifu.The intended procedure was percutaneous transluminal coronary angioplasty (ptca).The target lesion was left anterior descending (lad) artery with no calcification.There was moderate vessel tortuosity.The stent appeared already unfolded on the guidewire, before the device was in the correct position to be deployed into the vessel.The event caused a clinically relevant increase in the duration of the procedure when physician felt something wrong and changed the stent twice.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The sales rep thinks that it is not possible that the doctor accidentally applied positive pressure that caused the stent to begin deployment.The device will not be returned for evaluation as it was discarded by the hospital.Additional procedural details were requested but are unknown.".

Manufacturer Narrative

Additional classification ('dislodged' & 'resistance/friction' instead of 'damaged') was added and therefore dhr review was re-conducted (b)(6) 2019) and concluded that the system successfully passed the release tests.Ifu review performed on jan 6, 2020: no deviation form ifu was reported.Overall conclusions from final report dated (b)(6), 2020: 1.The review of the dhr (device history record) indicates that the product was supplied meeting specifications.2.The investigation was limited as we did not receive the used product or the angiogram.It is not possible to reach a definite conclusion as to how and why this event happened with the information that we received.3.There was no patient injury.

• Brand Name: ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 9435050
• MDR Text Key: 219781461
• Report Number: 3003084171-2019-00014
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P170008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 2.50 X 24
• Device Catalogue Number: LUN250R24C
• Device Lot Number: LNRCE00210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1