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

Model Number 2.5X17

Device Problems Crack (1135); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

Dhr review indicates that the product was supplied meeting specifications.Ifu review was preformed and no deviation from the ifu was reported.Conclusions of the final report of the complaint investigation: the review of the dhr (device history records), along with the information from the customer and the device analysis report indicate that the product was supplied meeting specifications.According to the device analysis, it may be assumed that the failure to cross, the broken shaft and the damage observed to the stent and tip evidently are the consequence of one or a combination of the common issues mentioned above and the use of excessive force, and are not related to medinol's manufacturing processes.There were no indications of any product anomalies or manufacturing issues.There was no injury to patient.No corrective action is required for this complaint.

Event Description

Initial report from the distributer received on (b)(6) 2019 stated: "broken shaft, calcified, circumflex " and noted that the device problem occurred during use.Further information was received on june 10, 2019 from the distributor: the patient was (b)(6) years old, male.The damage noted while trying to get across a severe stenosis.The device used in the patient.The shaft had bent during the procedure and cracked outside the patient body the product was stored and handled according to the instructions for use.There wasn't any damage noted to the packaging of the device.There was no difficulty removing the products from the package.There wasn't any difficulty experienced in prepping the device.The device was not damaged in any way prior to insertion into the patient.There wasn't any difficulty inserting the device into the patient.There was difficulty crossing the lesion.The procedure was completed with a different brand.There wasn't any patient injury.The product was removed in one piece from the patient except for the mid shaft that was broken.

• 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
• Manufacturer (Section G): MEDINOL LTD.; beck-tech bldg.; har hotzvim b, 8 hartom st.,; jerusalem, 97775 08; IS 9777508
• Manufacturer Contact: marina tikhonov demishtein ; kiryat atidim; bldg. 8, p.o.b. 58165; tel aviv, 61581-01 ; IS 6158101
• MDR Report Key: 8762249
• MDR Text Key: 209400864
• Report Number: 3003084171-2019-00010
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 2.5X17
• Device Catalogue Number: LUN250R17US
• Device Lot Number: LNRUS00069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• 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 Age: 85 YR