MAUDE Adverse Event Report: MEDINOL ELUNIR 2.75X12 US; CORONARY DRUG-ELUTING STENT

Model Number LUN275R12US

Device Problems Loss of or Failure to Bond (1068); Burst Container or Vessel (1074)

Patient Problem Vascular Dissection (3160)

Event Date 10/09/2018

Event Type  Injury  

Event Description

As reported, the physician pre-dilated 90% of the lesion with a semi compliant balloon near the ostium of the saphenous vein graft (svg).The elunir (2.75x12 us) stent was taken to the lesion; however, when the scrub tech turned the indeflator twice, the balloon burst at approximately 2 atmospheres (atm).The stent was severely under-deployed, and floating on the wire in the svg.The physician was able to remove the stent balloon and go in with a non-compliant post-dilatation balloon to appose the stent to the walls.The physician then saw a dissection, treated the dissection with a second elunir stent, and used ivus at the end to ensure that the first stent was truly apposed.There was no patient injury and the procedure results were good.The product was clinically used and will be returned for analysis.The dissection was proximal to the lesion, and it was not believed to be caused by the burst, but not 100% sure.The target lesion was the lad.The target lesion was calcified and had 90% stenosis.The product was stored and handled according to the instructions for use (ifu).The product looked normal when removed from its packaging.The product was prepped according to the ifu.The device was prepped normally (i.E.Maintain negative pressure).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.The sds was washed for release of air according to the ifu.There were no leaks nor bubbles observed.A non-cordis guide catheter was used.A buddy-wire was not used.There were no kinks nor other damages noted prior to inserting the product into the patient.The balloon catheter did not kink while being used.The contrast to saline ratio was 50:50.A non-cordis indeflator device was used.The same indeflator was used successfully with other devices.A little resistance was felt crossing the lesion with the device.Resistance was felt with the non-cordis pre-dilation balloon as well.The catheter was never in an acute bend.The device was not used for a chronic total occlusion (total occlusion >3 months).The device did not have to pass through a previously placed stent.The balloon inflated normally until it burst during its initial inflation.The product was removed intact (in one piece) from the patient.There were no other anomalies noted when the device was removed from the patient.Pursuant to the fda code of federal regulations, cordis is an importer of elunir¿ ridaforolimus eluting coronary stent system, a distributed product made by medinol.Therefore, cordis is required to report all complaints of deaths and serious injuries to the fda associated with this product.

• Brand Name: ELUNIR 2.75X12 US
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL; 8th hartom st. beck-tech bldg.; p.o.b. 45026; jerusalem 97775 08; IS 9777508
• MDR Report Key: 8048508
• MDR Text Key: 126508286
• Report Number: 1016427-2018-02228
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2018,11/07/2018

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: 11/30/2019
• Device Model Number: LUN275R12US
• Device Catalogue Number: LUN275R12US
• Device Lot Number: LNRUS00074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2018
• Distributor Facility Aware Date: 10/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention