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

Model Number 2.5X24

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

Dhr review received (july 04, 2018) - all manufacturing and release test documentation is present and meets requirements.Crimping, crossing profile, and securement measurements are all in compliance with requirements.All the released systems met specifications.

Event Description

Ptca and stenting was performed on ramus vessel.Trek 2.25x24 ptca balloon was used to pre dilate vessel over a choice pt floppy wire with no complications.Elunir 2.5x24 was advanced to lesion and stent was deployed.After deployment, physician stated the deployment pta balloon was stuck.Physician stated there was resistance withdrawing the pta balloon causing cordis xb 3.5 guide to deep seat and the choice wire to advance further into vessel.Physician was able to remove balloon with no complications or harm to patient.

Manufacturer Narrative

Ifu review was updated on august 28, 2018: no deviation of ifu was reported.Final report was revised to include additional information (september 02, 2018): overall conclusions: 1.The review of the dhr (device history record) along with the information received from the customer 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 or the angiogram.It is not possible to reach a definite conclusion as to how and why this event happened with the limited information that we received.4.The procedure was successfully completed and there was no injury to patient.

Event Description

Additional information received on august.22, 2018: the lesion was mildly calcified.The product was stored and handled according to the instructions for use (ifu).No damage was noted to the product packaging.The product was stored in the cath lab in a cabinet for 1 week.The preparation of the stent delivery system was performed according to the ifu.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped normally (i.E., maintained negative pressure).Excessive force was not applied on the stent delivery system during prep.The guide catheter did not exhibit any damage during the procedure and did not exhibit any kinks/bends.Excessive force was not applied on the stent delivery system while advancing it through the guide catheter.Nominal pressure was used to inflate the balloon.The balloon deflated normally, but experienced difficulty removing balloon post stent deployment.It is unknown whether the balloon re-wrapped properly.The product/ delivery system was removed intact (in one piece) from the patient.The physician did not use the balloon from elunir stent delivery system for post dilation.Excessive force was not applied to the delivery system during withdrawal.Elunir system was removed by advancing the balloon slightly forward and then pulled back into the sheath with slight tension.

Manufacturer Narrative

Device not available for return.Additional information: ifu review was performed (august 02, 2018): no additional information was received, therefore it's unknown whether there was any deviation/violation of the ifu.Final report (august 08, 2018): the review of the dhr (device history record) indicates that the product was supplied meeting specifications.There is no evidence to suggest that there were any manufacturing issues that contributed to the reported event.The investigation was limited as we did not receive the used product and the additional information that we requested.It is not possible to reach a definite conclusion as to how and why this event happened with the information that we received.The procedure was successfully completed and there was no injury to patient.

• 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, israel 97775 08; IS 9777508
• MDR Report Key: 7718232
• MDR Text Key: 115372360
• Report Number: 3003084171-2018-00037
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013567
• UDI-Public: 07290107013567
• 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,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: 2.5X24
• Device Catalogue Number: LUN250R24US
• Device Lot Number: LNRUS00156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 100