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

Model Number 2.5X20

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Device has not arrived yet dhr review (june 24, 2018) - all manufacturing and release test documentation is present and meets the requirements.Crimping, crossing profile, and securement measurements are all in compliance with the product requirements.All the released systems met specifications.

Event Description

The physician deployed the stent in distal lad at bifurcation of diag.Stent was deployed properly.After deployment, the physician brought the stent balloon up to 20 atm for 27 seconds for a second inflation.On a third inflation, he brought the balloon up to 20 atm for 10 seconds.When he went to remove the stent balloon delivery system, the balloon got stuck and split in half.He removed the catheter but the distal end of the system (markers and tip) were still on the wire in the artery.He was able to use a trap technique and pull everything out.A 7f cordis vista brite tip, 7f guidezilla, and a prowater wire were being used at the time of the event.The balloon either burst or got stuck on the guidezilla.The physician returned the product used.There was no injury to the patient.Additional information received on july 04, 2018: no excess force was used during prep.There was no difficulty removing the device from the packaging.Target lesion characteristics:(b)(4)% stenosis, (b)(4) degree tortuosity, the product was stored and handled according to the instructions for use (ifu).No damage was noted to the packaging of the device.The preparation of the stent delivery system was performed according to the ifu.The physician checked for any damage to the stent delivery system after removing the protective sleeve with shipping mandrel/stylet, and he didn't note any other damage prior to inserting the stent delivery system into the patient.The device was prepped normally (i.E., maintained negative pressure).Contrast media used was conray (b)(4) by (b)(6).Contrast:saline ratio was 100% contrast.There was no damage to guide wire during the procedure.Type and brand of inflation device used (indeflator/syringe): boston scientific encore 26.The guide catheter didn't exhibit any kinks/bends/damage.The guide wire didn't exhibit any kinks/bends/damage.Resistance/friction was noted when being delivered, stable push had to be maintained to deliver.No excessive force was applied on the stent delivery system while inserting it over the guide wire.The balloon deflated normally the first time.Both second and third post-dilatations were done with the same balloon from elunir stent delivery system from lot #lnrus00078.It is not clear when the balloon burst:at 20 atm (during post dilation) or when the balloon was deflated after the third inflation.Physician tried to remove sds and noticed it was split in half.The balloon that was split into two was still left on the delivery system.It is possible that the elunir system/balloon got caught on the guidezilla used during the procedure and damaged/split the balloon into two.The physician noticed that the balloon was split into two.The stent was successfully deployed.Excessive force was applied to the delivery system during withdrawal to remove it, because it was stuck.There was no injury to the patient.The patient is currently recovering at home.The procedural cd/angiogram is available.The device is available for analysis, and was already shipped.The devices were stored properly in the cath lab.The devices were stored in the cath lab for one month.Additional information received on july 08, 2018: images of the angio.Additional information received on july 10, 2018: a.014 guidewire and a boston scientific guidezilla were used in the procedure.

Manufacturer Narrative

Device analysis report conclusions (august 06, 2018; based on this investigation and the customer report, no determinant conclusion can be made as to the sequence of events that brought about the reported complaint.While the guidewire and the distal part of the product were apparently "locked" together it is not clear whether it is the result of the product, the guidewire or a combination of both.However, based on this investigation and the customer report it may be surmised that the product was supplied meeting specifications.This assumption is further supported by controls in place to prevent deformed or damaged products from being released.While no definite conclusion can be made as to the circumstance(s) of the reported failure, there are no signs of any product manufacturing issues.Angiogram images analysis on (b)(6) 2018): three (3) still angiogram images were received and analyzed.The overall conclusion is:"the images provided show no evidence of device malfunction or adverse patient events".Ifu review (august 08, 2018): according to the complaint description, "after deployment, the physician brought the stent balloon up to 20 atm for 27 seconds for a second inflation.On a third inflation, he brought the balloon up to 20 atm for 10 seconds".This was violation of section 12.5 of ifu.According to section 12.5, sub-section 4, "do not exceed the labeled rated burst pressure (rbp) of 18 atm (1824 kpa).Final report (august 09, 2018) overall conclusions: 1.The review of the dhr (device history record), results of device analysis investigation together with the customer report indicate that the returned product was supplied meeting specifications.2.Based on device analysis conclusion and the customer report, no determinant conclusion can be made as to the sequence of events that brought about the reported complaint.The reported severing of the system was confirmed.However, it is unclear whether the reported complaint was the result of issues with the product or the guide wire or a combination of both.Nonetheless, multiple inflations above product rbp and/or excessive forces exerted on the product likely led to the severing of the balloon and inner tube.There is no indication that the failure is related to medinol's manufacturing processes.3.Three still images of angiogram that were provided were reviewed and analyzed by medinol's interventional cardiologist.According to him, the images provided show no evidence of device malfunction or adverse patient events.4.The physician exceeded the labeled rated burst pressure (rbp) for second and third inflation of balloon at 20 atm.This was violation of section 12.5 of ifu.According to section 12.5, sub-section 4, "do not exceed the labeled rated burst pressure (rbp) of 18 atm (1824 kpa)".This may have contributed to the severing of the balloon and inner tube.5.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: 7688849
• MDR Text Key: 114025979
• Report Number: 3003084171-2018-00031
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013550
• UDI-Public: 07290107013550
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 2.5X20
• Device Catalogue Number: LUN250R20US
• Device Lot Number: LNRUS00078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2018
• Date Manufacturer Received: 07/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1