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

Model Number 3.0X20

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

The following information was received from the distributor on february 12, 2024: stent 3x20 was insert after predilation.The physician tried to move the stent to the lesion several times and because in the past after several attempts he knew that there was a problem with the struts, he took the stent out to check it and saw that the strut of the stent was bend outside.No death or serious injury was reported.Additional information was received from the distributor on march 03, 2024.The following was mentioned: 1.The target vessel was the lad.2.There was no vessel tortusity/angulation.3.The physician couldn't reach the target lession 4.The size of the guiding catheter been used is ebu 3.5 5.No damage observed/noted on the device packaging.6.No other damage been observed by the physician prior to inserting the stent delivery system into the patient.7.The device was prepared normally.8.No excessive force was applied on the stent delivery system while trying to reach the lesion.9.No excessive force was applied on the stent delivery system during withdraw.10.No resistance or abnormal friction was noticed by the physician while inserting the balloon over the guide wire.11.The procedural angiogram of the process is not available.

Manufacturer Narrative

On 04 march, 2024 dhr (device history record) review was performed and concluded that the device was supplied, meeting its specifications.

Manufacturer Narrative

On 04 march, 2024 the dhr (device history record) of lot# elmil0090a was reviewed.No deviations and no rejections were found.The device was supplied, meeting all the specifications.Following the device arrival, a device analysis was signed on 15 april, 2024 (see enclosed).On 17 april, 2024 a review of ifu for customer complaint was performed, conclusions of which does indicate upon any deviation/s (ifu # 91200016).Final complaint report, signed on 06 may, 2024 revealed the following conclusions: a.The dhr (device history record) of lot # elmil0090a was reviewed.No unusual percentage of rejects related to the stent or to the balloon were observed.B.According to the device analysis report, there was a strut uplift that probably occurred during withdrawal.C.The results of this investigation indicate that the returned product was supplied to the customer meeting specifications.D.Failure to cross is usually the consequence of one or a combination of the common issues such as patient anatomy, lesion disposition/ composition, operator technique, ancillary equipment and/or appropriate device selection.E.The events of this complaint are addressed in the elunir-perl dfmea report, and the risk remains low.No new risks were identified.F.There was no injury to the patient.

Event Description

The following information was received from the distributor on february 12, 2024: stent 3x20 was insert after predilation.The physician tried to move the stent to the lesion several times and because in the past after several attempts he knew that there was a problem with the struts, he took the stent out to check it and saw that the strut of the stent was bend outside.No death or serious injury was reported.Additional information was received from the distributor on march 03, 2024 the following was mentioned: 1.The target vessel was the lad.2.There was no vessel tortuosity/angulation.3.The physician couldn't reach the target lesion 4.The size of the guiding catheter been used is ebu 3.5 5.No damage observed/noted on the device packaging.6.No other damage been observed by the physician prior to inserting the stent delivery system into the patient.7.The device was prepared normally.8.No excessive force was applied on the stent delivery system while trying to reach the lesion.9.No excessive force was applied on the stent delivery system during withdraw.10.No resistance or abnormal friction was noticed by the physician while inserting the balloon over the guide wire.11.The procedural angiogram of the process is not available.Further clarification was received from the distributor on march 18, 2024 the previously reported "the physician couldn't reach the target lesion" replaced with "the physician reached the target lesion but couldn't cross it".

• Brand Name: ELUNIR-PERL RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD; bech-tech bldg. har hotzvim b,; 8 hartom st.,; jerusalem, israel 97775 08; IS 9777508
• Manufacturer (Section G): MEDINOL LTD; har hotzvim beck tech bldg.,; 8 hartom st.; jerusalem, israel 97775 08; IS 9777508
• Manufacturer Contact: marina tikhonov demishtein ; kiryat-atidim; bldg., 8; tel aviv, israel 61581-01 ; IS 6158101
• MDR Report Key: 18854206
• MDR Text Key: 337809008
• Report Number: 3003084171-2024-00001
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IS
• PMA/PMN Number: P170008/S037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.0X20
• Device Catalogue Number: ELM300R20IL
• Device Lot Number: ELMIL0090A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1