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

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 07/30/2018

Event Type  Death  

Manufacturer Narrative

Currently, since there is no information on the product, no further investigation can be performed at this stage.

Event Description

This initial report refers to an event reported under 3003084171-2018-00039, the information in the mdr report was as follows: initial description of the event: stent stripped off delivery system.It was intended for the lad and stripped off proximal lad and brought back through the guide radial.It would (not) come out of the radial artery and therefore he accessed femoral and snare the stent into the femoral.Patient passed after the procedure on the floor.Additional information received: additional information from cordis, august 06, 2018: the stent delivery system is available for return.The stent was not kept once it was taken out of the patient.It was told that the stent had nothing to do with the death later on.Additional information from cordis, august 13, 2018: the device was not used in an acute mi setting.The lesion was not in stent re-stenosis.There were more than two (2) stents deployed.A guideliner was used as the guide extension system.The physician had difficulty crossing the lesion with the device the physician attempted to retract the system with the guide catheter, which pulled back into the guide liner and then the whole system was removed radially but the stent stayed and was in the radial artery.It is not sure whether an autopsy was performed.As described in 3003084171-2018-00039 report, additional information, received from cordis on august 21, 2018 suggested that in this event, 2 additional stents were used as described below: it is unknown what the reason was for the patient's death, but it is not stent related.The patient was a high risk pci.The patient was conscious while entering the procedure and after the procedure.It is not sure whether there are angio images are available, but they probably won't be shared.Two more stents were used during the procedure, both of them were elunir.Additional information as described in the following revised case detailed report, was received from cordis on september 05, 2018: revised description summary: during a percutaneous coronary intervention (pci) procedure, the physician had difficulty crossing the lesion in the left anterior descending (lad) with a 3.0x33 elunir stent.While attempting to retract the whole system, the stent stripped off the delivery system in the proximal lad and was brought back through the guide via the radial artery.It would (not) come out of the radial artery and therefore the physician accessed the femoral artery and snared the stent into the femoral.Two (2) additional elunir stents were implanted in the same procedure prior to the reported event.The patient passed away after the procedure on the floor.The device will be returned.The devices were not used in an acute myocardial infarction (mi) setting.The lesion was not in stent-restenosis.More than 2 stents were deployed.A non-cordis guide extension catheter was used.The procedure was a high risk pci and for a high risk patient who was conscious while entering the procedure as well as afterwards.Additional information, was received from medinol us on september 05, 2018: the 2 additional elunir stents were placed without incident.

• 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, 97775 08; IS 9777508
• Manufacturer (Section G): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• Manufacturer Contact: marina demishtein ; kiryat atidim; bldg. 8; tel aviv, 61581-01 ; IS 6158101
• MDR Report Key: 7872188
• MDR Text Key: 120105306
• Report Number: 3003084171-2018-00041
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2018
• 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): Death