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

Model Number 2.5X17

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 04/26/2018

Event Type  Death  

Manufacturer Narrative

Device not returned to manufacturer.Dhr and ifu reviews are attached.Final report is attached.Per general instructions - for form fda 3500a medwatch (for mandatory reporting), since the procedure was performed with two (2) devices from two (2) different lots (lnrus00031 and lnrus00037), two (2) separate mdrs were issued.The second lot (lnrus00037) is provided in the mdr under mfr report #3003084171-2018-00022.(b)(4).

Event Description

Initial information received ((b)(6) 2018): a (b)(6) female came into the er nonresponsive, dnr.Patient was then sent, intubated, to the cath lab for emergent catheterization.Initial angio revealed totally occluded lad.Physician performed multiple inflation angioplasty with apex 2.0x12 balloon over a bmw wire.Physician then deployed the 3.0x12 and the 2.5x17 elunir, proximal to distal, overlapped, and performed follow up angiography.Physician removed his guidewire, performed another angio and then determined the artery needed a third elunir distal to the two that had been deployed.At that time, thrombus was noted in the midsection of the stented segment, the physician was unable to rewire the lad and the patient succumbed while on the cath lab table additional information received ((b)(6) 2018): dnr= do not resuscitate / revive the products were stored properly according to the instructions for use (ifu).The products were prepped according to instructions for use (ifu).The patient came to cath lab on heparin iv 100 units / hour.And additional 2000 units of heparin were administered during the procedure.Two acts were performed: 240 and 300 the patient prediagnosis was hypertension, chf and cva.The patient came to cath lab with st elevation mi.Totally occluded lad.There was no note on difficulty delivering the first two stents.The deployed stents order was proximal to distal.Post dilation was performed.The angiographic result of the first 2 stents was satisfactory.The physician did not note the thrombosis on the follow up angiogram performed before the wire was removed.The physician remove the wire after the first two stents since he felt he was finished with the intervention of the lad.The 3rd stent was required since the physician did angio after the wire was pulled and noted a third lesion, distal, that he felt needed another stent.The physician fail to rewire the lad since it began shutting down.Cardiac arrest was the cause of death.The angiographic results are not available for review.Per general instructions - for form fda 3500a medwatch (for mandatory reporting), since the procedure was performed with two (2) devices from two (2) different lots (lnrus00031 and lnrus00037), two (2) separate mdrs were issued.The second lot (lnrus00037) is provided in the mdr under mfr report #3003084171-2018-00022.

• 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
• Manufacturer (Section G): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• Manufacturer Contact: marina demishtein ; beck tech bldg; kiryat atidim, bldg. 8; tel aviv, israel 61581-01 ; IS 6158101
• MDR Report Key: 7555848
• MDR Text Key: 109609504
• Report Number: 3003084171-2018-00021
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013543
• UDI-Public: 07290107013543
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: 2.5X17
• Device Catalogue Number: LUN250R17US
• Device Lot Number: LNRUS00031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 95 YR