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

Model Number 3.0X17

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problem Vascular Dissection (3160)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Dhr review was performed (october 17, 2018): the review of the dhr (device history record) indicates that the product was supplied meeting specifications.Ifu review was performed (october 18, 2018): no deviation of ifu was reported.The angiogram has arrived to medinol (november 04, 2018) review of angiogram by medinol's interventional cardiologist (november 06, 2018): patient has a crtp pacemaker.Radial approach.Baseline angiogram reveals 2 vessel disease: a moderate lesion in the mid-rca and a tight lesion at the mid-lad at the bifurcation of d2.The rca is wired but no pci done (negative ffr?).Double wiring of lad-d2.Pre-dilation with a 2*12mm sc balloon performed successfully.Elunir 3*17mm positioned in the mid-lad and inflated to 16 atm.At 11:20:36 there is an image of the inflated stent with what appears to be an intact stent-balloon the next image at 11:21:40 shows that there is an edge dissection of the lad at the distal end of the stent with extravasation of contrast into the surrounding tissue.There is no image showing the bursting of the stent balloon, maybe this was seen on fluoro but was not saved.The dissection is treated by implanting a 2.75*18 resolute onyx stent with overlap of the elunir stent.Post dilation of the stents is done.Final angiogram shows good flow in the lad and d2.The following conclusions were made: the lad lesion was tight but not heavily calcified.There is no evidence of balloon burst on the initial stent delivery.The lad was dissected possibly as a result of over-inflation of the elunir stent relative to the size of the mid-lad.Possibly the high pressure inflation (though below rated burst pressure) relative to the size of the vessel had some relationship to the bursting of the stent-balloon.

Event Description

Initial description of the case (sent by cordis on (b)(6) 2018), occurring at (b)(6) hospital, (b)(6): "i was unfortunately in a case today with a customer at (b)(6) hospital where they used an elunir and the delivery balloon burst.Fortunately, there was no impact of this to the patient.They have kept hold of the delivery catheter and packaging" an overview of the case: pci to lad - initially looking to do bifurcation stenting with diagonal vessel.Pre-dilated vessel with a 2.0mm x 12mm ikzauchi zero semi-compliant balloon to 14atm.3.0mm x 17mm elunir used, balloon inflated to 16atm and burst.2.75mm x 18mm resolute onyx stent used inside of the elunir positioned at the outflow.Post-dilated vessel with a 3.25mm x 10mm raiden3 inflated to 12atm.The customer stated that he would not have expected the balloon to have burst in this case, as the lesion was not particularly calcified, and he also prepped the lesion well.Additional information (received from cordis on (b)(6) 2018): the product was stored and handled according to the instructions for use (ifu).No damage was noted to the packaging of the device.The device was stored in a cabinet in the lab.The product has been stored in the cabinet in the labs for around 3 months.The preparation of the stent delivery system was performed according to the ifu.The physician didn't check whether there was any damage to the stent delivery system after removing the protective sleeve with shipping mandrel/stylet.The physician 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).There was no damage to guide wire during the procedure.Type and brand of inflation device was used (indeflator/syringe) - needed to be confirmed.Vessel/target lesion characteristics (calcified,% stenosis, etc.) - the physician said that it wasn't heavily calcified.The guide catheter/guide wire didn't exhibit any kinks/bends/damage.Resistance/friction noted at any time - needed to be confirmed.Excessive force applied on the stent delivery system while inserting it over the guide wire - needed to be confirmed.The balloon did not deflate normally, it burst on inflation.The stent was successfully deployed.Excessive force applied to the delivery system during withdrawal - needed to be confirmed.Current status of the patient - was fine when he left the labs.Additional information (received from cordis on (b)(6) 2018), complementing/clarifying the information received from cordis on (b)(6) 2018 above (same clause numbers used): type and brand of inflation device was used (indeflator/syringe) - boston scientific.Vessel/target lesion characteristics(calcified,% stenosis, etc.) - no significant tortuosity or calcification.No resistance/friction was noted at any time.No excessive force was applied on the stent delivery system while inserting it over the guide wire.The balloon burst on inflation at 16 atm.No excessive force was applied to the delivery system during withdrawal.Additional information (received from cordis on (b)(6) 2018): the event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.

Manufacturer Narrative

Additional manufacturer data: device analysis report(b)(6)2018: the returned product was received at the r&d lab on (b)(6)2018.Results of this investigation reveal that the balloon did not leak or burst.Furthermore, the distal section of the outer (about 12 cm immediately proximal to the balloon) also did not exhibit a leak.However, the large amounts of red residues (blood) in the system outer indicate that there was a leak in the system.While the blockage of the tubes by the dried blood did not allow verification, it may be assumed that the leak was located in the rx port region.The system also exhibited bends.The bends are likely the result of post procedure handling.Often the used products are "coiled/folded" and "thrusted" into a receptacle in a manner that leads to deformation/bends in the system.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.It should be noted that elunir¿ coronary stent systems undergo 100% in-line leak testing to prevent the release of products with such defects.Final report (b)(6)2019 overall conclusions: 1.The review of the dhr (device history record) and the results of device analysis investigation together with the customer report indicate that the returned 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.According to the angiogram review, there is no evidence of balloon burst on the initial stent delivery.The lad was dissected possibly as a result of over-inflation of the elunir stent relative to the size of the mid-lad.4.Based on the device analysis report, it was determined that the system balloon did not leak/burst.However, the large amounts of red residues in the system outer indicate that there was a leak in the system.Although it could not be confirmed, due to the blockage in the system tubes, it is surmised that the leak occurred in the rx port region.The cause/circumstances leading to the leak in the rx port region are unclear.5.There was no injury to the patient.------------------------------------------------------------------------------------------------------------------------------------------------------------------------- corrected data: section h6 - device code: in the initial mdr, a balloon leak was suspected.Hence, the code "1074: burst container or vessel" was used.However, following device analysis it was found out that the balloon did not burst, but rather there was a leak in the rx port region.Therefore, the h6 code was updated to:"4210 - leakage/seal".Section h10 - additional manufacturer data: 1.In the original mdr (submitted (b)(6)2018), the angiogram analysis included the following conclusion: "possibly the high pressure inflation (though below rated burst pressure) relative to the size of the vessel had some relationship to the bursting of the stent-balloon".Nonetheless, the device analysis had shown that the balloon had not burst, and it is surmised that the leak occurred in the rx port region (see conclusion #4 in the final report overall conclusions above).2.In the original mdr (submitted (b)(6)2018), the date of angiogram analysis was (b)(6)2018.The correct date is (b)(6)2018.

• 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: 8047149
• MDR Text Key: 126512938
• Report Number: 3003084171-2018-00050
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 10/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 3.0X17
• Device Catalogue Number: LUN300R17C
• Device Lot Number: LNRCE00016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention