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

Model Number 3.00 X 12

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

As the case detail report include information on four (4) sizes of the elunir product and since each mdr present only one (1) product, this report is related to one (1) out of four (4) elunir's products, involved in this event.Attempts to obtain additional information and identify the related product {out of the four (4) sizes of the elunir} will continue.Mfr report # for the other related cases: 3003084171-2019-00015, 3003084171-2019-00017, 3003084171-2019-00018.

Event Description

The initial case report was obtained on nov.17, 2019 and included the following "description as reported": "as reported by the sales rep, patient came in with a stemi on (b)(6) due to in stent thrombosis.Patient was on brilinta and went off due to financial reasons.After procedure the patient was put on plavix.It is unknown if the patient's dosage was correct for plavix or if the patients body didn't respond to the medication as well as it wasn't in the patients system long enough after the procedure which could have caused the elunir stents to shut down.Boston sci synergy stents were placed in the mid circ and mid lad" in addition, the information detailed in 'product information' in the same report included four (4) products.There have been several attempts to get information about which product within the reported four (4) was involved, but no answer has been received on this matter.Additional information received from distributor on dec 3, 2019 stated as follows: the device stored and handled as per the instruction for use (ifu).No damage was noted to the packaging of the device.The device prep as per the ifu 1 stent in mid circ and 1 stent in mid lad none were overlapped.The patient did not have any medical history found relevant for this case (e.G.Bleeding disorder, coronary artery disease.) neither site pre-dilated.Mid circ was inflated for 12atm for 11 seconds and mid lad was inflated for 14atm for 24 seconds.Good wall apposition was observed via angio.Patient is currently doing fine.Additional information received from distributor on dec 6, 2019 stated as follows: the stents for were implanted on 11/6 and it was 3.0x12 and 3.0x17 to the mid circ and also a 2.5x12 to the mid lad.

Event Description

Additional information (dated dec.08, 2019).The physician knew that the stemi was due to in-stent thrombosis based on the ekg from the stemi's and the fact the stents were all shut down in both patients.

Manufacturer Narrative

Device history record (dhr) review performed on dec 23, 2019 have indicated the product was supplied meeting.Specifications.Ifu review (dated jan.15, 2020) no deviation/violation from ifu was reported.Final report (dated jan 16, 2020 ) overall conclusions: 1.The review of the dhr (device history record), along with the information from the customer indicate that the product was supplied meeting specifications.2.Stent thrombosis and myocardial infarction are well-known potential adverse events that may be associated with the implantation of a coronary stent in coronary arteries and are listed as such in section 8 of the elunir ifu.In this case the events may have been caused by the patient going off brilinta and/or by inappropriate dosage / insufficient time / absence of response with plavix.3.The current status of the patient is fine.

• 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
• MDR Report Key: 9458205
• MDR Text Key: 187269095
• Report Number: 3003084171-2019-00016
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013703
• UDI-Public: 07290107013703
• 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: 11/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 3.00 X 12
• Device Catalogue Number: LUN300R12US
• Device Lot Number: LNRUS00171
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 79