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

Model Number 2.5X33

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Dhr review was conducted on feb.21st, 2019, in concluded that the product was supplied meeting specifications.

Event Description

The initial complaint received from the distributer: "after pre-dilation of the circumflex artery, there was an attempt to inflate the balloon.The physician saw that the balloon did not inflate and did not respond properly to nominal pressure and in parallel the contrast material leaked out of the distal portion of the shaft.There was no tear visible in the balloon itself.It was decided at this stage to insert another balloon and inflate the stent.The stent was successfully opened and implanted.No harm was done to the patient".Additional information was received on mar.4th, 2019 and on mar.5th 2019: the lesion was calcified and there wasn't any vessel tortuosity.Guiding catheter xb3.5 6f cordis was used.Filder asahi 0.014 guide wire was used.The sds was washed for release of air according to the ifu.There weren't any leaks or bubbles observed.No excessive force was applied on the stent delivery system while inserting it over the guide wire.A guideliner or other guide extension system was used.A buddy-wire was not used, the balloon catheter did not kink while being used.There wasn't any resistance/friction while inserting the balloon through the guide catheter over the guide wire.The device prep normally (i.E.Maintain negative pressure).The current status of the patient is well.The catheter was never in an acute bend.There was no difficulty crossing the lesion.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the device.There were no kinks or other damages noted prior to inserting the product the product into the patient.

Event Description

Additional information received from distributor, on mar 12 2019: total of three elunirs were implanted in the circ: 4x17mm , 2.5x17mm and the reported 2.5x33mm.A different stent brand (3.5x13mm) was implanted in ostial lad.

Manufacturer Narrative

Corrected data: initial reported for the case is as listed above and not as reported in the initial mdr submitted mar.11, 2019.Although same size and model, the involved device has an international catalog number (lnr250r33in) and thus the udi codes listed in the report submitted on mar.11, 2019 does not apply to it.Manufacturer narrative: angioram evaluation has been performed for this case and documented as (b)(4) on mar 12, 2019 with the following conclusions: the 2.5x33 mm elunir final result appeared normal; there aren't images showing unusual under expansion of this stent; the leakage of contrast is not seen on this angiogram.Ifu review has been performed for this case on mar 18, 2019: no deviation from ifu was reported.Device analysis for this investigation is attached herein.Final report for of this investigation, dated apr 1, 2019, have concluded the following: the review of the dhr (device history record) indicates that the product was supplied meeting specifications.The leakage of contrast and under expansion of the stent were not seen on the angiogram.According to the device analysis report, the reported system leak was confirmed and observed to be in the rx port region.The balloon did not exhibit any leaks or abnormalities.Although the device analysis concluded that it is unclear whether the leak in the rx port region is related to medinol's manufacturing processes, the dhr review indicates that it is unlikely that there were any manufacturing issues that contributed to the reported event.The procedure was completed successfully; the stent was successfully opened and implanted.

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD.; beck-tech bldg.; har hotzvim b, 8 hartom st.,; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 8406874
• MDR Text Key: 139076356
• Report Number: 3003084171-2019-00006
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013581
• UDI-Public: 07290107013581
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 2.5X33
• Device Catalogue Number: LUN250R33IN
• Device Lot Number: LNRIN00254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2019
• Date Manufacturer Received: 03/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1