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

Model Number 3.0X33

Device Problems Positioning Failure (1158); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

During the catheterization procedure on the patient with a difficult case of chronic total occlusion (cto) balloons were employed to widen (pre-dilate) the right coronary artery (rca).Blockage was diagnosed in the distal region of the artery.The first stent was successfully implanted and opened correctly, in the distal region (lnrin00019 2.75*20).While attempting to insert a second stent next to the existing one to enhance treating a long lesion the physician experienced difficulty in the arterial passage (which was calcified and full of plaque) while using a lnrin00027 3*33 stent so he therefore pulled back to remove the stent for the purpose of re-inserting it for an additional attempt.While removing the stent from the artery and the patient's body, the operator noticed that the struts had opened and unraveled in the proximal area and the cylinder was opened and damaged.It was decided to implant a new stent in its place, also of the elunir type, (the third one being used, the second in the artery) lnrin00058 3.5*33.The stent was implanted and opened correctly.There was no injury nor damage to the patient; the artery remained open.Additional information received on april 29, 2018: the elunir stent delivery system was stored and handled according to the ifu.There was no damage noted to the product packaging upon inspection prior to use.No excessive force was applied to the device while removing the product from the packaging or while removing it from the patient's vessel.

Manufacturer Narrative

Attached: device analysis report, ifu review, final report.Investigation conclusion: the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Attachment: [(b)(4)_device analysis report.Pdf, (b)(4)_ifu review.Pdf, (b)(4)-final report.Pdf].

Event Description

Complaint outside us.Additional information received: device analysis report (june 10, 2018) - see attached.Ifu review (june 11, 2018) - see attached.Final report (june 13, 2018) - see attached.

Manufacturer Narrative

Corrected data: in the previous mdr, submitted june 20, 2018, the ifu review was attached, with no ifu deviation reported.On august 22, 2018 it was realized that us ifu was reviewed (ifu #(b)(4)) instead of the correct international ifu (ifu #(b)(4)), since the event took place outside us.The correct ifu was reviewed on august 22, 2018.No deviation was reported.

• 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: 7482398
• MDR Text Key: 107211626
• Report Number: 3003084171-2018-00018
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013970
• UDI-Public: 07290107013970
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 3.0X33
• Device Catalogue Number: LUN300R33IN
• Device Lot Number: LNRIN00027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1