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

Model Number 3.5X15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Intimal Dissection (1333); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 11/09/2019

Event Type  Injury  

Manufacturer Narrative

Device history record review indicated the device was supplied meeting specifications.

Event Description

Initial description was obtained on nov 17, 2019 as follows: as reported, patient came in with a stemi on (b)(6) 2019 due to in stent thrombosis.Per evaluation from physician elunir stent appeared to be adequately apposed but possibly under deployed.A different stent was placed within current elunir stent to remove possible outflow obstruction that may have contributed to in stent thrombosis.There was a possible proximal edge dissection so additional lad stent was placed.Thrombosis traveled to om1 and circ so stents were placed in both vessels.Product malfunction/failure mode as reported: inaccurate placement: the stent is deployed in the wrong location or does not fully cover the target lesion.Vessel: mid left anterior descending.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 one stent was implanted.The patient did not have any medical history found relevant for this case (e.G.Bleeding disorder, coronary artery disease.) the site pre-dilated prior to stent placement: 10atms for 15 seconds.Inflation pressure was used to deploy the stent: 12atms for 40 seconds.Good wall apposition was observed via angio.Patient is currently doing fine.

Manufacturer Narrative

Device history record performed on dec 29, 2019 indicated the device was supplied meeting its specifications.Ifu review performed on jan 1, 2020 indicated:" no deviation/violation of the ifu was reported," final investigation report concluded, on jan 16, 2020 the following: 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 a well-known potential adverse event 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.Moreover, the physician mentioned that it is possibly that the stent was under deployed.3.The current status of the patient is fine.

Event Description

Clarification received from the distributor have stated: "the physician knew that the stemi was due to in-stent thrombosis based upon the ekg from the stemi and the fact the stent was shut down.".

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD; beck-tech bldg.; har hotzvim b, 8 hartom st.,; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 9458540
• MDR Text Key: 185931552
• Report Number: 3003084171-2019-00019
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013871
• UDI-Public: 07290107013871
• 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
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 3.5X15
• Device Catalogue Number: LUN350R15US
• Device Lot Number: LNRUS00128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 86